Press Release

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.

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