Kombinace lifileucelu a pembrolizumabu dosáhla ve studii fáze 2 u 24 pacientů s pokročilým melanomem 62,5% míry objektivní odpovědi a 29,2% kompletních remisí.
62.5% Confirmed Objective Response Rate (ORR) and 29.2% Complete Response (CR) Rate in Final Phase 2 Analysis
Median Overall Survival (OS) Not Reached at More than 4 Years of Median Follow-up
Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2026 Reinforces Ongoing TILVANCE-301 Phase 3 Trial
PHILADELPHIA and MADRID, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that one-time lifileucel combined with pembrolizumab demonstrated a 62.5% ORR and a 29.2% CR rate, with median OS not reached at 50.9 months of median study follow-up in the final Phase 2 analysis in frontline advanced melanoma. The Phase 2 results were presented on October 23, 2026 in a Proffered Paper oral session at the ESMO Congress 2026 in Madrid, Spain.
In frontline advanced melanoma, approximately half of patients treated with combination immune checkpoint inhibitor (ICI) therapy do not achieve long-term benefit, a widely recognized unmet need.1 Following successful adoption of lifileucel in the post-anti-PD-1 therapy setting, this Phase 2 data supports the earlier use and potential approval of lifileucel plus pembrolizumab in frontline advanced melanoma. Iovance estimates that 70,000 patients with frontline advanced melanoma are addressable each year in global markets with high prevalence.2
ESMO Presentation Highlights: Cohort 1A of the IOV-COM-202 Trial (NCT03645928)
IOV-COM-202 is a multicohort, multicenter Phase 2 trial of lifileucel plus pembrolizumab in patients with solid tumors. The final analysis in frontline advanced melanoma (Cohort 1A) included 24 patients treated with one-time lifileucel that met pre-determined manufacturing specifications and pembrolizumab monotherapy for up to 24 months.
The physician-assessed confirmed ORR by RECIST v1.1 was 62.5% (15/24; 95% CI: 40.6, 81.2), including a 29.2% CR rate. The disease control rate was 83.3% (20/24; 95% CI: 62.6, 95.3). Median duration of response (DOR) was not reached (range: 4.3 to 57.7+ months) at a median follow-up of 26.9 months for DOR.
Median progression-free survival (PFS) was 19.8 months (95% CI: 3.6 months to not reached). Median PFS after second line of therapy was 34.3 months (95% CI: 6.8 months to not reached), indicating that subsequent systemic therapy remains feasible after frontline lifileucel and pembrolizumab, including additional ICI therapy. Median OS was not reached (95% CI: 19.2 months to not reached) at a median study follow-up of 50.9 months.
Safety was consistent with the underlying disease and known safety profiles of one-time lifileucel and pembrolizumab. Late adverse events were consistent with continuous use of pembrolizumab monotherapy, further differentiating lifileucel plus pembrolizumab from ICI combinations used in the frontline setting.
“About half of patients do not experience lasting benefit with frontline combination immunotherapy for advanced melanoma,” stated Dr. Andrew J.S. Furness, Consultant Medical Oncologist and Solid Tumour Cellular Therapy Lead at The Royal Marsden National Health Service Foundation Trust, Leader of the Cellular Therapy and Translational Immunology Group at The Institute of Cancer Research, London, and Principal Investigator in IOV-COM-202 and TILVANCE-301 trials. “A single administration of lifileucel plus pembrolizumab demonstrated compelling response rates and durability that compare favorably to other ICI combination approaches in frontline advanced melanoma, with median overall survival not reached at more than four years of follow-up. These remarkable Phase 2 results provide a strong scientific rationale to investigate earlier treatment with lifileucel in the TILVANCE-301 trial.”
Translational analyses support the positive clinical results in Cohort 1A. T-cell receptor (TCR) sequencing detected clones from the infused lifileucel product in the peripheral blood for as long as 12 months after infusion (n=13), consistent with the strong DOR benefit of lifileucel.
Noah Berkowitz, M.D., Ph.D., Chief Medical Officer of Iovance, stated, “The final Cohort 1A results demonstrate unprecedented efficacy and a potentially best-in-class clinical profile for lifileucel combined with pembrolizumab in frontline advanced melanoma. These data, together with supportive translational findings, reinforce the importance of our ongoing TILVANCE-301 Phase 3 randomized trial to support a new approval for lifileucel in frontline advanced melanoma.”
The presentation is available at www.iovance.com. Iovance will also present the first clinical data for lifileucel in soft tissue sarcomas in a Rapid Oral presentation on Monday, October 26, 2026 (Abstract #3725RO).
About TILVANCE
TILVANCE-301 (NCT05727904) is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. The trial is enrolling at more than 80 sites in the U.S., Canada, Europe, and Asia-Pacific. The dual primary endpoints are ORR and PFS assessed by independent review committee. TILVANCE-301 is designed to support approval for lifileucel in combination with pembrolizumab in frontline advanced melanoma and to serve as the confirmatory trial for full U.S. approval of Amtagvi® in previously treated advanced melanoma.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at nearly 100 authorized treatment centers (ATCs). The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. Headquartered in Pennsylvania with offices and laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.
About the ESMO Congress
The ESMO Congress is organized by the European Society for Medical Oncology (ESMO) and is one of the world’s most influential annual oncology meetings, bringing together more than 37,000 clinicians, researchers, patient advocates, and industry representatives from around the world. The ESMO Congress 2026 takes place October 23–27, 2026, at IFEMA Madrid, Spain, and features presentations of practice-changing clinical data, translational science, and educational programming across all major tumor types. For more information, visit www.esmo.org.
References
Larkin J, et al. N Engl J Med. 2019;381:1535-46.SEER and GLOBOCAN epidemiology data and internal data on file. Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events, or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the size of the addressable patient populations for, and the acceptance by the market of, our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our iCTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial supply or clinical supply; the risks related to our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our clinical studies and cohorts, and meetings with regulatory authorities, may support registrational studies and subsequent approvals by regulatory authorities, including the risk that our registrational trials, including TILVANCE-301, may be delayed, may not meet their primary endpoints, or may not support approval; clinical results, whether preliminary, interim, or final, which may include efficacy and safety results, from clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior or future trials or cohorts, including the risk that the Cohort 1A results of IOV-COM-202 may not be predictive of results in the ongoing TILVANCE-301 trial; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities or others; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control.
Iovance Advances TIL Cell Therapy into a New Chapter in Solid Tumor Treatment
Two Oral Presentations to Showcase Deep, Durable Responses with TIL Cell Therapy in Frontline Melanoma and Previously Treated Soft Tissue Sarcomas
PHILADELPHIA, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, will present five abstracts from its TIL platform at the European Society for Medical Oncology (ESMO) Congress 2026, including two oral presentations of new clinical data in previously untreated advanced melanoma and, for the first time, in two soft tissue sarcomas. The congress takes place October 23–27, 2026, in Madrid, Spain.
The oral presentation of results with lifileucel in two previously treated soft tissue sarcomas, undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), are from a pilot clinical trial led by Memorial Sloan Kettering Cancer Center (MSKCC) and supported by Iovance. Soft tissue sarcomas are rare and highly heterogeneous cancers comprising approximately 80 tumor subtypes, with an estimated incidence of 4–5 cases per 100,000 people annually in Europe and ~3.5 new diagnoses per 100,000 people in the United States each year.1, 2 For patients with advanced UPS and DDLPS who progress following standard therapies, treatment options remain limited and prognosis is often poor, highlighting the need for new approaches that can deliver meaningful and durable responses.
“This is our first congress presentation of TIL cell therapy in two soft tissue sarcomas with significant unmet need,” said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer of Iovance. “The efficacy and durability observed in this early cohort are what moved us quickly toward our ongoing SARATOGA registrational trial of lifileucel in UPS and DDLPS. This is the broadest look yet at how Iovance’s growing TIL platform performs across solid tumors.”
A second oral presentation, as a proffered paper, highlights the final Phase 2 results for lifileucel in combination with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-naive advanced melanoma. Additional posters will highlight emerging translational and real-world evidence, including an indirect comparison suggesting that lifileucel may approximately double four-year overall survival rates compared with standard-of-care therapies in anti-PD-1-resistant advanced melanoma. Together, these data continue to expand the evidence base for Iovance’s TIL platform.
“Our Phase 2 results in frontline, advanced melanoma show deep, durable responses with a single treatment of lifileucel added to pembrolizumab,” Berkowitz continued. “These data reinforce the scientific rationale behind TILVANCE-301, our Phase 3 trial evaluating lifileucel earlier in the treatment of advanced melanoma, highlighting the opportunity this approach may offer patients who don’t achieve lasting benefit from today’s frontline treatments.”
Oral Presentations
Proffered Paper (Abstract #2072O): Efficacy and Safety of Lifileucel and Pembrolizumab in Patients with Immune Checkpoint Inhibitor-Naïve Advanced Melanoma: Final Results from IOV-COM-202 Study
Authors: Andrew J.S. Furness, et al.
Session: Friday, October 23, 2026, 16:15–17:45 CEST Rapid Oral (Abstract #3725RO): Lifileucel in Patients with Undifferentiated Pleomorphic Sarcoma (UPS) or Dedifferentiated Liposarcoma (DDLS)
Authors: Lauren Banks, et al.
Session: Monday, October 26, 2026, 08:30–10:00 CEST Poster Presentations
Poster (Abstract #4359P): Enrichment of Putative Tumor-Reactive Clones in NSCLC Patients Responding to Lifileucel: Temporal Single Cell Analysis from a Clinical Trial
Authors: Martin Wermke, et al.
Session: Friday, October 23, 2026, 15:15–16:00 CEST Poster (Abstract #2117P): Indirect Comparison of Overall Survival (OS) between Lifileucel versus Standard-of-Care (SoC) in US Real-World Settings in Anti-PD-1 Resistant Advanced Melanoma
Authors: Barbara Ma, et al.
Session: Saturday, October 24, 2026, 12:00–12:45 CEST Poster (Abstract #2125P): Lifileucel versus Nivolumab plus Relatlimab (NIVO+RELA) in Anti–PD-(L)1-Resistant Advanced Melanoma: A Match-Adjusted Indirect Comparison (MAIC) of Efficacy Outcomes
Authors: Gino K. In, et al.
Session: Saturday, October 24, 2026, 12:00–12:45 CEST The ESMO Congress 2026 scientific program and abstracts are available at https://www.esmo.org/meeting-calendar/esmo-congress-2026. Presentations will be available following the conclusion of each session on www.iovance.com and the ESMO Congress virtual platform.
About SARATOGA
SARATOGA (NCT07741877) is a registrational Phase 2 clinical trial evaluating the safety and efficacy of lifileucel in patients with advanced (metastatic or unresectable) undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy. UPS and DDLPS are high-grade, aggressive soft tissue sarcomas associated with poor prognosis and limited treatment options for patients who progress on chemotherapy.
About TILVANCE
TILVANCE-301 (NCT05727904) is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at nearly 100 authorized treatment centers (ATCs). The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. Headquartered in Pennsylvania with offices and laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.
About the ESMO Congress
The ESMO Congress is organized by the European Society for Medical Oncology (ESMO) and is one of the world’s most influential annual oncology meetings, bringing together more than 37,000 clinicians, researchers, patient advocates, and industry representatives from around the world. The ESMO Congress 2026 takes place October 23–27, 2026, at IFEMA Madrid, Spain, and features presentations of practice-changing clinical data, translational science, and educational programming across all major tumor types. For more information, visit www.esmo.org.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “achievable,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
References
1. Gronchi A, et al. Soft tissue and visceral sarcomas: ESMO-EURACAN-GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(11):1348-1365. doi:10.1016/j.annonc.2021.07.006.
2. National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2026 Estimates. Cancer Stat Facts: Soft Tissue including Heart Cancer https://seer.cancer.gov/statfacts/html/soft.html . Accessed October 13, 2026.
Iovance Biotherapeutics zvýšila výhled tržeb za celý rok 2026 na 410 až 420 milionů USD díky silné poptávce v USA po Amtagvi a Proleukin. Střed rozpětí je o 55 milionů USD výše než dříve.
New Guidance Represents an Increase of $55 Million at the Midpoint from the Prior Range of $350 to $370 Million
Strong U.S. Demand for Amtagvi and Proleukin Drives Increased Outlook
PHILADELPHIA, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today raised its full year 2026 total revenue guidance range to $410 to $420 million, driven by strong U.S. demand for Amtagvi® (lifileucel) and Proleukin. The midpoint represents an increase of $55 million, or ~15%, over the previous guidance range of $350 to $370 million and implies nearly 60% annual growth in total revenue.
“Our record second quarter and sustained demand for Amtagvi and Proleukin led us to raise our full year 2026 total revenue guidance by $55 million at the midpoint,” said Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer. “Increasing patient demand and our current manufacturing schedule provide strong visibility into our third and fourth quarter revenues. In addition, lifileucel continues to advance across our registrational programs in new solid tumor indications, while continued manufacturing and operating efficiencies accelerate our progress toward profitability.”
Iovance most recently reported record second quarter 2026 total product revenue of $99.3 million, has grown its authorized treatment center (ATC) network to ~100 centers, and remains on track for expansion to at least 110 ATCs by year-end 2026.
Iovance expects to report third quarter 2026 financial results in early November 2026. This update completes the guidance review announced with the Company’s second quarter 2026 results.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at nearly 100 authorized treatment centers (ATCs). The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. Headquartered in Pennsylvania with offices and laboratories in California and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.
Forward-Looking Statements
Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events, or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products; the acceptance by the market of our products and product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture our therapies at our iCTC facility, including the risk that our ability to increase manufacturing capacity at our facility may adversely affect our commercial launch; the risks related to our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain regulatory authority approval of our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with regulatory authorities, may support registrational studies and subsequent approvals by regulatory authorities, including the risk that any of our planned registrational trials may not support approval; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities; the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.
Why 2 Small Biotechs May Hold the Key to New Cancer TreatmentsIovance Biotherapeutics NASDAQ: IOVA said it is expanding its tumor-infiltrating lymphocyte, or TIL, therapy platform across multiple solid-tumor indications after reporting a record second quarter marked by nearly $100 million in revenue and a 56% margin.
Speaking at the H.C. Wainwright 28th Annual Global Investment Conference, Brian Gastman, Iovance’s executive vice president of translational medicine and research, said the company has moved TIL therapy from academic research into commercial use. He said Iovance has treated more than 2,000 patients clinically and commercially and has two approved and commercialized therapies: Amtagvi, its flagship TIL therapy, and Proleukin, also known as interleukin-2.
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3 Biotech Stocks to Watch: Iovance, Neurocrine & VikingGastman said the company’s cash runway exceeds $300 million and extends into mid-2028, providing what he described as a “clear line of sight to profitability.”
TIL Manufacturing and Market Access TIL therapy is a one-time, patient-specific treatment made from immune cells collected from a patient’s tumor. The cells are expanded into the billions and then returned to the same patient after preparatory treatment, Gastman said.
The Top 5 Analysts Ranked by MarketBeat and Stocks They CoverIovance manufactures the therapy at its Iovance Cell Therapy Center in Philadelphia. The facility supports clinical and commercial supply and has modular capacity for more than 5,000 patients, according to Gastman. He said the facility is a strategic asset for controlling supply, expanding margins and creating operating leverage as treatment volumes increase.
The company has more than 95 authorized treatment centers, including roughly one-third in community settings, and expects to reach 110 centers by year-end. Gastman said more than 95% of U.S. patients are within 200 miles of a treatment center, while more than 80% are within 100 miles.
He also said Iovance has payer policies covering more than 250 million lives, including Medicare and commercial coverage, representing more than 75% of the U.S. population.
Melanoma Program and Frontline Trial Gastman said the data supporting Amtagvi’s FDA approval, as well as approvals in Canada and Australia, showed durable responses in heavily pretreated melanoma patients. In an analysis of four experienced treatment centers, Iovance reported a 44% response rate, with response rates above 50% among patients treated in the second-line setting, he said.
The company is also studying TIL therapy earlier in advanced melanoma. In the IOV-COM-202 Cohort 1A trial, Amtagvi combined with pembrolizumab in immune checkpoint inhibitor-naïve patients produced response rates in the mid-60% range and a 30% complete-response rate at the time of analysis, according to Gastman.
Gastman said more mature data from the study are scheduled for an oral presentation at the European Society for Medical Oncology meeting. The regimen is also the experimental arm in Iovance’s international Phase III TILVANCE-301 confirmatory trial, which is intended to support confirmation of the company’s second-line accelerated approval and potentially support frontline approval.
Pipeline Targets Lung Cancer, Sarcoma and Endometrial Cancer Iovance is advancing its standard TIL platform in non-small cell lung cancer, soft-tissue sarcoma and endometrial cancer. For non-squamous non-small cell lung cancer without EGFR, ROS or ALK alterations, Gastman said the company has previously reported a response rate of nearly 26%. With more than two years of follow-up, median duration of response had not been reached, he said.
The company expects to complete the lung cancer trial soon and present a larger data set by the end of the year, with a supplemental biologics license application planned for 2027. The program has received Fast Track designation from the FDA.
In soft-tissue sarcoma, Iovance is studying TIL therapy in undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. Gastman said an initial patient group showed a 50% response rate, with all responses ongoing and, in some cases, deepening. The program has progressed into a registrational trial called SARATOGA.
For advanced endometrial cancer, the company identified a signal in serous endometrial carcinoma. Gastman said TIL therapy produced a 40% response rate and 100% disease-control rate in the studied population. Iovance is engaging with the FDA and evaluating potential expedited development pathways, he said.
Next-Generation Programs Iovance is also developing genetically modified TIL therapies and an engineered interleukin-2 program. IOV-4001 is a PD-1-inactivated TIL therapy that has been tested in melanoma and has moved into non-small cell lung cancer.
The company’s IOV-5001 program is designed to express IL-12 at the cell surface within the tumor microenvironment, an approach intended to limit broader systemic exposure. Gastman said Iovance plans to evaluate the therapy in tumors that have historically been more difficult for TIL therapy, including colorectal cancer, triple-negative breast cancer and head and neck cancer.
Its IOV-3001 engineered IL-2 program is currently in dose escalation, with additional information expected soon, Gastman said.
About Iovance Biotherapeutics (NASDAQ:IOVA)Iovance Biotherapeutics, Inc is a biotechnology company focused on developing and commercializing individualized cell therapies for patients with cancer. Its platform uses tumor-infiltrating lymphocytes (TILs), immune cells collected from a patient's tumor, expanded in a manufacturing facility and returned to the patient to help recognize and attack cancer cells.
The company's lead product, Amtagvi (lifileucel), is an autologous TIL therapy approved by the U.S. Food and Drug Administration for certain adults with unresectable or metastatic melanoma that has progressed following prior treatment.
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Iovance Biotherapeutics se dostala na 52týdenní maximum, přestože k pohybu nebyla žádná vlastní zpráva; od začátku roku akcie vzrostly o více než 200 %.
Iovance Biotherapeutics Inc. (NASDAQ:IOVA) is trading at a 52-week high on Thursday, despite having no news to justify the move. Year to date, the stock has surged over 200%.
• Iovance Biotherapeutics shares are testing new highs. Why did IOVA hit a new high?
The momentum seems to come from breakthrough data from Moderna Inc. (NASDAQ:MRNA) and Merck & Co Inc.‘s (NYSE:MRK) individualized cancer therapy for advanced skin cancer.
On Wednesday, the companies said that at a pre-planned interim analysis, the investigational combination delivered statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to standard Keytruda alone.
Iovance’s Amtagvi Targets Advanced MelanomaInvestors should note that in February 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Iovance’s Amtagvi (lifileucel), a one-time tumor-infiltrating lymphocyte (TIL) therapy.
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It is derived from a patient’s surgically removed tumor, expanded in a lab, and then reinfused into patients.
Indication covers adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.
Moderna/Merck’s intismeran autogene is an mRNA-based individualized neoantigen therapy (INT) designed specifically for each patient based on the unique set of mutations within their tumor to train and activate the immune system to recognize and fight cancer.
Iovance Reports Early Soft-Tissue Sarcoma DataIn February, Iovance shared positive early data from a pilot clinical trial for its TIL cell therapy in advanced soft-tissue sarcomas.
Among the first six evaluable patients treated with lifileucel monotherapy, the trial showed a 50% confirmed objective response rate.
Most recently, the cancer drug company reported a second-quarter loss of 11 cents per share, beating the consensus loss of 14 cents per share.
Sales reached $99.313 million, beating the consensus of $87.832 million. U.S. Amtagvi revenue reached approximately $91 million.
Iovance Biotherapeutics reaffirmed fiscal 2026 sales guidance of $350 million-$370 million versus the consensus of $362.083 million.
Analysts Raise Price ForecastsUBS maintains Iovance Biotherapeutics with a Neutral rating and raises the price target from $4 to $7.
Mizuho reaffirms the Outperform rating for IOVA stock and raises the price target from $10 to $11.
IOVA Stock Price Activity: Iovance Biotherapeutics shares were up 9.64% at $8.76 at the time of publication on Thursday, according to Benzinga Pro data.
Iovance Biotherapeutics oznámila za 2. čtvrtletí tržby ve výši 99,3 milionu USD, což je meziročně o 66 % více, a čistá ztráta klesla na 47,3 milionu USD. Akcie zároveň dosáhly nového 52týdenního maxima.
Shares of biopharmaceutical company Iovance Biotherapeutics (IOVA +0.95%) have been skyrocketing lately. The California-based business reported earnings recently, which pleased investors, and that's putting it lightly, as the stock also hit a new 52-week high.
What's gotten investors so bullish on the healthcare stock, and is now a good time to buy it?
Image source: Getty Images.
Amtagvi drives significant sales growth for Iovance in Q2 On Aug. 6, Iovance released its second-quarter earnings numbers, which showed strong growth for its promising cancer treatment, Amtagvi (lifileucel). The company's revenue for the June quarter totaled $99.3 million, which was an increase of 66% from the prior-year period. The lion's share of the company's revenue comes from Amtagvi, which was responsible for $91 million.
The Food and Drug Administration approved Amtagvi in early 2024 as a treatment for unresectable or metastatic melanoma. It has the potential to be a blockbuster for Iovance, as it may bring in more than $1 billion in revenue at its peak. However, how much it generates will depend on its approval for other indications.
In addition to generating significant revenue growth this past quarter, the company also drastically reduced its losses during the period. Iovance's net loss came in at $47.3 million, which was less than half the $111.7 million loss it incurred in the same period last year. As Amtagvi continues to reach more patients and sales grow, there is hope that the business may have a path to profitability, which would make the stock a more attractive investment option for more risk-averse investors.
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Can Iovance's stock soar higher this year? Although Iovance's stock has been red hot of late, I think it can still rise higher. It's down more than 70% over the past five years, and now, with the business having an approved treatment and significant revenue to show for, it's not nearly as risky an investment as it was in the past. And with terrific margins, there's reason to be optimistic that it may get to breakeven in the future. The stock may even become an attractive acquisition target for a larger healthcare company, given its modest market cap of around $3 billion.
There will inevitably be some risk with the stock because of its lack of profitability, but with some tremendous progress and positive signs around Iovance, I wouldn't be surprised if it were to rise a whole lot higher in the long run. This can be an excellent growth stock for investors who are comfortable taking on some risk and uncertainty.
Iovance Biotherapeutics (IOVA - Free Report) came out with a quarterly loss of $0.11 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to a loss of $0.33 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +35.29%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.19 per share when it actually produced a loss of $0.19, delivering no surprise.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Iovance Biotherapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $99.31 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 13.73%. This compares to year-ago revenues of $59.95 million. The company has topped consensus revenue estimates two times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Iovance Biotherapeutics shares have added about 59% since the beginning of the year versus the S&P 500's gain of 12.8%.
What's Next for Iovance Biotherapeutics?While Iovance Biotherapeutics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Iovance Biotherapeutics was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.15 on $93.41 million in revenues for the coming quarter and -$0.60 on $359.12 million in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
One other stock from the same industry, ADC Therapeutics SA (ADCT - Free Report) , is yet to report results for the quarter ended June 2026.
This company is expected to post quarterly loss of $0.19 per share in its upcoming report, which represents a year-over-year change of +62%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
ADC Therapeutics SA's revenues are expected to be $20.15 million, up 7% from the year-ago quarter.
Iovance Biotherapeutics letos posílila o 74 % a její tržby v 1. čtvrtletí vzrostly meziročně o 45 % na 71,4 milionu USD. Akcie ale zůstává vysoce riziková kvůli regulačním a výrobním překážkám.
After several years of underperforming the market, Iovance Biotherapeutics (IOVA 1.61%) is finally bouncing back. The biotech company's shares have soared 74% this year. However, the stock still looks pretty cheap -- it is trading for just under $5 apiece. And for what it's worth, several Wall Street analysts think it could rise even more. Its average price target (according to Yahoo! Finance) is $8.80. Should investors rush to buy the company's shares?
Image source: The Motley Fool.
A high-risk, high-reward play Iovance Biotherapeutics developed Amtagvi, an approved medicine for treating melanoma. Amtagvi is manufactured from patients' own cancer-fighting cells, which are harvested, grown in a lab, and then reinserted back into the patient. Amtagvi's sales are growing at a good clip. In the first quarter, Iovance Biotherapeutics' revenue (mostly from this product) increased 45% year over year to $71.4 million. Meanwhile, Iovance Biotherapeutics is making progress in regions outside the U.S. It earned approval for Amtagvi in Canada last year, and could see the medicine's sales improve meaningfully as it ramps up commercial efforts in the country.
Further, Iovance Biotherapeutics could obtain approval for Amtagvi in several other countries, including across the European Union. Launching the medicine in these regions would significantly expand its addressable opportunity, likely even more so than the Canadian market. Elsewhere, the company is making clinical progress. Iovance Biotherapeutics is developing Amtagvi for the treatment of endometrial cancer. The company also boasts several other pipeline candidates. Provided the biotech company can earn significant clinical wins over the next few years while also making solid commercial progress with Amtagvi, it could maintain the momentum it has had so far this year.
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However, several factors could derail Iovance Biotherapeutics' plans, including the very real risk of clinical or regulatory setbacks every drugmaker faces. It has already encountered several. For instance, Iovance Biotherapeutics announced earlier this year that it was withdrawing its regulatory application for Amtagvi in the United Kingdom due to "procedural reasons," although it said it would resubmit it promptly. Beyond potential regulatory roadblocks, there is a much bigger issue with the Company. The medicines it develops are complex to manufacture and administer.
It takes about a month for Amtagvi to be manufactured after patients' cells have been harvested. And before receiving treatment, they have to undergo chemotherapy. Can Iovance Biotherapeutics eventually turn a profit, given that its therapies are so complex and expensive to administer? It's not clear that it can, and the company's bull case depends on a lot of things going right. Iovance Biotherapeutics may maintain its momentum if it continues to post strong financial results while eventually earning new approvals and label expansions. But the company is trading at a low price for a reason, and it could fall much further if it faces headwinds. So, Iovance Biotherapeutics is fairly risky, and only investors comfortable with volatility should consider initiating a position.
