Iovance Announces Data Showing Durable Responses with Lifileucel TIL Cell Therapy in Advanced Soft Tissue Sarcomas at ESMO 2026

Four partial responses remained ongoing at the data cutoff, while the registrational SARATOGA study is enrolling patients.

Rhea-AI Summary

Iovance Biotherapeutics (IOVA) reported a 50% confirmed objective response rate with lifileucel in a pilot trial of advanced soft tissue sarcomas. Among the first eight evaluable patients, four had partial responses: two with undifferentiated pleomorphic sarcoma (UPS) and two with dedifferentiated liposarcoma (DDLPS). All responses remained ongoing at 6+, 26+, 40+, and 46+ weeks at the September 9, 2026 data cutoff. Responses were physician-assessed using RECIST v1.1, standardized tumor-response criteria.

Patients had received 1–7 prior systemic therapies. The safety profile was consistent with the lifileucel treatment regimen in other indications. FDA fast track designation for advanced UPS and DDLPS was granted in the second quarter of 2026. The Phase 2 SARATOGA registrational trial is enrolling, with independently reviewed objective response rate as its primary endpoint.

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point50% confirmed objective response rate in eight evaluable patients, including two partial responses in each sarcoma subtype.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Phase 2 SARATOGA is enrolling to support Iovance’s pursuit of two new lifileucel approvals.
• Minor pointAll four responses ongoing at 6+, 26+, 40+, and 46+ weeks at September 9, 2026 cutoff.
• Minor pointFDA fast track designation granted for advanced UPS and DDLPS in the second quarter of 2026.
• Minor pointAdditional metastatic soft tissue sarcomas are being explored in Iovance’s clinical development program.

Negative

• Minor pointPilot efficacy results cover the first eight evaluable patients and use physician-assessed responses.

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Key Figures

Confirmed ORR: 50% Evaluable patients: 8 patients Ongoing partial responses: 4 responses; at 6+, 26+, 40+, and 46+ weeks +4 more

Confirmed ORR

50%

First eight evaluable patients; physician-assessed by RECIST v1.1

Evaluable patients

8 patients

Lifileucel pilot trial

Ongoing partial responses

4 responses; at 6+, 26+, 40+, and 46+ weeks

As of the September 9, 2026 data cut-off

Second-line treatment ORR

Less than 5%

Current options cited for metastatic UPS and DDLPS

Second-line treatment mPFS

~2–3 months

Current options cited for metastatic UPS and DDLPS

Second-line treatment mOS

~9–10 months

Current options cited for metastatic UPS and DDLPS

FDA fast track designation

Second quarter of 2026

Lifileucel in advanced UPS and DDLPS

Key Terms

orr, recist v1.1, mos, mpfs

4 terms

orr medical

"Confirmed Objective Response Rate (ORR) with All Responses Ongoing"

Objective Response Rate (ORR) is the percentage of patients in a clinical trial whose tumors shrink or disappear by a predefined amount after treatment. For investors, ORR is a quick, measurable signal of a therapy’s effectiveness—like early sales numbers for a new product—and strong ORR data can boost a drug’s commercial prospects and company valuation, while weak ORR can temper expectations.

recist v1.1 medical

"confirmed ORR by RECIST v1.1 was 50%"

RECIST v1.1 is a standardized set of rules used in cancer trials to measure how solid tumors change over time, defining when tumors shrink, grow, or stay the same based on imaging scans. Investors care because these consistent measurements determine key trial results and regulatory decisions—like whether a drug is seen as effective—so RECIST-based outcomes directly affect a therapy’s approval prospects, market potential, and company valuation.

mos medical

"median overall survival (mOS) of less than two years"

mos is a common abbreviation for months, used to indicate a time span in financial statements, forecasts, contracts, or trial timelines. Timeframes matter to investors because they show how long cash, obligations, or expected results will play out—similar to seeing how many months your household budget must cover expenses, it helps assess risk, liquidity, and when returns or obligations are likely to occur.

mpfs medical

"median progression-free survival (mPFS) of only 5 to 6 months"

The MPFS (Medicare Physician Fee Schedule) is the official price list Medicare uses to set how much it will pay doctors and other clinicians for specific medical services. Think of it like a menu of reimbursement rates: changes to the MPFS raise or lower what providers earn for each procedure, which can directly affect health-care providers’ revenue, profit margins and the valuations of companies that rely heavily on Medicare payments — information investors use to judge financial risk and growth prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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50% Confirmed Objective Response Rate (ORR) with All Responses Ongoing in an Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2026

Unprecedented Efficacy in Both Refractory Undifferentiated Pleomorphic Sarcoma (UPS) and Dedifferentiated Liposarcoma (DDLPS)

PHILADELPHIA and MADRID, Oct. 26, 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, today announced that one-time lifileucel monotherapy demonstrated unprecedented efficacy with deep, durable responses across two difficult-to-treat soft tissue sarcomas with limited treatment options, metastatic UPS and DDLPS, in a pilot trial presented orally at the ESMO Congress 2026 in Madrid, Spain.

Among the first eight evaluable patients, physician-assessed confirmed ORR by RECIST v1.1 was 50%. Four partial responses (2 in UPS and 2 in DDLPS) were all ongoing (at 6+, 26+, 40+, and 46+ weeks) as of the data cut-off on September 9, 2026. The eight evaluable patients had deep responses despite significant disease burden (range in baseline target sum of diameters: 39.0 to 177.6 mm), were refractory to prior lines of systemic therapy (range: 1-7), and received lifileucel that met pre-determined manufacturing specifications. The safety profile was consistent with the lifileucel treatment regimen across other indications.

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}

“The unprecedented efficacy for one-time lifileucel in UPS and DDLPS sets a new bar for response rates with TIL therapy in refractory patients and underscores the powerful potential of our TIL platform across many solid tumor cancers,” said Brian Gastman, M.D., Executive Vice President, Translational Medicine and Research at Iovance Biotherapeutics. “UPS and DDLPS patients also experienced deepening responses over time, consistent with lifileucel’s responses in melanoma, non-small-cell lung cancer, and other solid tumors. On the heels of this pilot trial, we are rapidly enrolling the SARATOGA registrational study to support two new approvals for lifileucel. Iovance is strongly positioned to drive potential adoption in refractory UPS and DDLPS patients that are highly concentrated at academic centers that overlap with our existing commercial footprint.”

“Lifileucel showed encouraging response rates and lasting benefits in patients with UPS and DDLPS who are refractory to frontline standard of care,” said Lauren Banks, M.D., Ph.D., Sarcoma Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSKCC) and principal investigator of the pilot and SARATOGA trials of lifileucel. “This level of durability provides meaningful time for patients with refractory UPS and DDLPS suffering from high disease burden, poor quality of life, and a lack of effective treatments, including no approved immunotherapy options.”

Patients with metastatic UPS and DDLPS have a devastating prognosis, with median overall survival (mOS) of less than two years and median progression-free survival (mPFS) of only 5 to 6 months after first-line chemotherapy.³ In recent clinical studies, the current second-line treatment options delivered an ORR of less than 5%, mPFS of ~2-3 months, and mOS of ~9-10 months.^4-6

The U.S. Food and Drug Administration (FDA) granted fast track designation for lifileucel in advanced UPS and DDLPS in the second quarter of 2026 based on initial results from the pilot trial. Iovance is exploring lifileucel in additional metastatic soft tissue sarcomas with high unmet need as part of its clinical development program.

The presentation is available at www.iovance.com.

About the SARATOGA (IOV-SAR-201) Trial

SARATOGA (NCT07741877) is a registrational Phase 2 clinical trial evaluating the safety and efficacy of lifileucel in patients with advanced (metastatic or unresectable) UPS or DDLPS who were refractory to at least one prior line of anthracycline-based chemotherapy. SARATOGA is now enrolling at MSKCC and other major U.S. cancer centers. The primary endpoint is ORR per RECIST v1.1 by independent review committee (IRC), with secondary endpoints including complete response rate, duration of response, disease control rate, PFS, OS, and safety and tolerability.

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 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

1. Gronchi A, et al. Ann Oncol. 2021;32(11):1348-1365. doi:10.1016/j.annonc.2021.07.006.
2. National Cancer Institute SEER Program. 2026 Estimates. Accessed October 13, 2026.
3. Banks L, et al. ESMO 2026.
4. Parikh RC, et al. Cancer. 2018.
5. Italiano A, et al. Ann Oncol. 2012.
6. Jones RL, et al. Ann Oncol. 2023.

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 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; 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.

CONTACTS

Investors
IR@iovance.com
650-260-7120 ext. 150

Media
PR@iovance.com
650-260-7120 ext. 150

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Iovance’s lifileucel sarcoma pilot trial show at ESMO 2026?

Lifileucel produced a 50% physician-assessed confirmed objective response rate among the first eight evaluable patients. Four partial responses, two in UPS and two in DDLPS, remained ongoing at 6+, 26+, 40+, and 46+ weeks at the September 9, 2026 data cutoff.

Who is eligible for Iovance’s SARATOGA lifileucel trial?

SARATOGA evaluates lifileucel in patients with advanced, metastatic or unresectable UPS or DDLPS refractory to at least one prior line of anthracycline-based chemotherapy. The Phase 2 registrational trial is enrolling at Memorial Sloan Kettering Cancer Center and other U.S. cancer centers.

What secondary outcomes will Iovance’s SARATOGA trial measure?

SARATOGA’s secondary endpoints include complete response rate, duration of response, disease control rate, progression-free survival, overall survival, and safety and tolerability. These supplement its primary endpoint of objective response rate assessed by an independent review committee using RECIST v1.1.