Iovance Biotherapeutics Reports Potential Best-in-Class Clinical Data for Lifileucel TIL Cell Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC)
Iovance (NASDAQ: IOVA) reported interim registrational Phase 2 IOV-LUN-202 data for lifileucel in previously treated advanced nonsquamous NSCLC: an objective response rate (ORR) of 25.6% (10/39 patients), including 2 complete responses, and a disease control rate of 71.8%. The median duration of response was not reached after a median follow-up of 25.4 months. The FDA gave positive regulatory feedback on trial design and potency assays. Iovance expects to progress toward a supplemental BLA in 2026 with a potential commercial launch in H2 2027. Safety trends improved after a reduced lymphodepletion regimen, with shorter post-IL-2 hospital stays.
Iovance (NASDAQ: IOVA) ha riportato dati intermedi di fase 2 registrazionale IOV-LUN-202 su lifileucel in NSCLC avanzato nonsquamoso precedentemente trattato: una tasso di risposta obiettiva (ORR) del 25,6% (10/39 pazienti), inclusi 2 risposte complete, e un tasso di controllo della malattia del 71,8%. La mediana della durata della risposta non è stata raggiunta dopo un follow-up mediano di 25,4 mesi. La FDA ha fornito un feedback regolatorio positivo sul design dello studio e sugli esatti di potenza. Iovance prevede di procedere verso un BLA supplementare nel 2026 con un potenziale lancio commerciale nella seconda metà del 2027. Le tendenze di sicurezza sono migliorate dopo un regime di lymphodepletazione ridotto, con tempi di degenza post-IL-2 più brevi.
Iovance (NASDAQ: IOVA) informó datos interinos de registrational fase 2 IOV-LUN-202 sobre lifileucel en NSCLC no escamoso avanzado previamente tratado: una tasa de respuesta objetiva (ORR) del 25,6% (10/39 pacientes), incluyendo 2 respuestas completas, y una tasa de control de la enfermedad del 71,8%. La duración mediana de la respuesta no alcanzó tras un seguimiento medio de 25,4 meses. La FDA dio comentarios regulatorios positivos sobre el diseño del ensayo y los ensayos de potencia. Iovance espera avanzar hacia un BLA suplementario en 2026 con un lanzamiento comercial potencial en la segunda mitad de 2027. Las tendencias de seguridad mejoraron después de un régimen de linfodepleción reducido, con estancias hospitalarias post-IL-2 más cortas.
Iovance (NASDAQ: IOVA) 은 이전에 치료받은 진행성 비편평 NSCLC에서 lifileucel에 대한 중간 등록용 2상 IOV-LUN-202 데이터를 발표했습니다: 객관적 반응률(ORR) 25.6% (39명 중 10명), 완전 반응 2건 포함, 그리고 질병통제율 71.8%. 중위 추적관찰 기간 25.4개월에서 반응의 중위 지속 기간은 도달하지 못했다. FDA는 시험 설계 및 효능 검사에 대해 긍정적인 규제 피드백을 제공했습니다. Iovance는 2026년에 보충 BLA를 진행하고 2027년 하반기 상업적 출시 가능성을 기대합니다. 감소된 림포데플리션 요법 이후 안전성 경향이 개선되었으며, IL-2 이후 병원 체류도 짧아졌습니다.
Iovance (NASDAQ : IOVA) a publié des données intermédiaires de phase 2 IOV-LUN-202 enregistrales sur lifileucel chez des patients atteints de NSCLC non à prédominance squameuse avancé et préalablement traités : un taux de réponse objective (ORR) de 25,6% (10/39 patients), dont 2 réponses complètes, et un taux de contrôle de la maladie (DCR) de 71,8%. La durée médiane de réponse n'a pas été atteinte après un suivi médian de 25,4 mois. La FDA a apporté des retours réglementaires positifs sur la conception de l'essai et les essais de puissance. Iovance prévoit de progresser vers une BLA supplémentaire en 2026 avec un lancement commercial potentiel au cours du deuxième semestre 2027. Les tendances de sécurité se sont améliorées après un régime de lymphodéplétion réduit, avec des séjours post-IL-2 à l'hôpital plus courts.
Iovance (NASDAQ: IOVA) berichtete über Zwischenresultate der registrierenden Phase-2-Studie IOV-LUN-202 zu Lifileucel im zuvor behandelten fortgeschrittenen nicht-kleinzelligen NSCLC: eine Objektiv-Response-Rate (ORR) von 25,6% (10/39 Patienten), darunter 2 komplette Remissionen, und eine Krankheitskontrollrate von 71,8%. Die mittlere Ansprechdauer wurde nicht erreicht nach einer mittleren Nachbeobachtungszeit von 25,4 Monaten. Die FDA gab positives regulatorisches Feedback zum Studiendesign und zu Potenztests. Iovance geht davon aus, 2026 mit einem ergänzenden BLA fortzufahren, mit potenzieller kommerzieller Markteinführung im 2. Halbjahr 2027. Sicherheitsentwicklungen verbesserten sich nach einem reduzierten Lymphodepletionsregime, mit kürzeren post-IL-2 Krankenhausaufenthalten.
Iovance (المُدرجة في NASDAQ: IOVA) أبلغت عن بيانات مرحلية (Phase 2) registَرية IOV-LUN-202 عن lifileucel في NSCLC غير مُتقسّم سابقاً: معدل الاستجابة الموضوعية (ORR) بنسبة 25.6% (10 من 39 مريضاً)، بما في ذلك استجابتان كاملتان، ومعدل السيطرة على المرض 71.8%. لم تُصل إلى مدة الاستجابة المتوسطة بعد متابعة متوسطة بلغت 25.4 شهراً. قدمت FDA تعليقات تنظيمية إيجابية حول تصميم التجربة واختبارات القوة. تتوقع Iovance التقدم نحو BLA مكمل في 2026 مع احتمال الإطلاق التجاري في النصف الثاني من 2027. تحسنت اتجاهات السلامة بعد نظام تخفيض المناعة المخفف، مع تقليص فترات الإقامة في المستشفى بعد IL-2.
- ORR 25.6% (10 of 39 patients)
- Median duration of response not reached after 25.4 months
- FDA provided positive feedback on trial design and assays
- Company expects sBLA progression in 2026 and H2 2027 launch
- Single-arm Phase 2 data versus standard therapy may limit comparability
- Small sample size: 39 patients in reported cohort
- Safety requires management: NMA-LD and IL-2–related hospitalizations
Insights
Interim Phase 2 data show a higher response rate and prolonged durability versus the stated comparator; regulatory path and launch timing are now defined.
The data report a 25.6% objective response rate (10/39 patients, including two complete responses) and a median duration of response not reached after a median follow up of
Key dependencies and risks remain: confirmatory response assessments, full safety and durability data, and regulatory review of the proposed potency matrix. The release notes safety improvements after a reduced lymphodepletion regimen, but it still lists expected toxicities linked to NMA-LD and IL-2. Watch for confirmatory response status, complete safety tables, formal submission timing toward the supplemental BLA in
Median Duration of Response Not Reached after 25 Months Follow Up
Lifileucel Launch in Previously Treated Advanced NSCLC Expected in Second Half of 2027
SAN CARLOS, Calif., Nov. 03, 2025 (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 interim data from its registrational Phase 2 IOV-LUN-202 trial of lifileucel monotherapy in patients with previously treated advanced nonsquamous NSCLC without actionable genetic mutations.
The objective response rate (ORR) was
Iovance will present additional data from the IOV-LUN-202 trial at an upcoming medical meeting in 2026. The U.S. Food and Drug Administration (FDA) previously provided positive regulatory feedback on the IOV-LUN-202 trial design and the proposed potency assay matrix to support registration. This trial design aligns with FDA guidance for single-arm trials to support accelerated approvals in conditions with unmet medical need. The IOV-LUN-202 trial is expected to progress in 2026 towards a supplemental Biologics License Application for lifileucel in nonsquamous NSCLC and a potential launch in the second half of 2027.
“It is exciting to see such an impressive response rate and durability observed in previously treated patients with NSCLC, because today there are only very limited treatment options, none of which demonstrate this quality of response and durability,” said Martin Wermke, M.D., Professor for Experimental Cancer Therapy and Director at the National Center for Tumor Diseases Dresden. “One-time treatment with lifileucel monotherapy has the potential to benefit many patients with advanced NSCLC following initial treatment with an immune checkpoint inhibitor.”
Following initial treatment with immune checkpoint inhibitor and chemotherapy, patients with advanced NSCLC have limited treatment options and often receive chemotherapy, which has limited durability. Standard-of-care docetaxel monotherapy in patients with nonsquamous NSCLC previously treated with immune checkpoint inhibitors and chemotherapy has recently shown an ORR of
The safety profile for the lifileucel treatment regimen was consistent with the underlying disease, non-myeloablative lymphodepletion (NMA-LD), and interleukin-2 (IL-2). Improvements in the overall safety profile have been observed, without affecting efficacy, following the introduction of an updated regimen of reduced NMA-LD for IOV-LUN-202. Patients treated with the updated regimen showed a reduction of median post-IL-2 hospitalization days by more than half and lower incidence and shorter time to resolution of cytopenias compared with the initial regimen.
“Lifileucel has demonstrated a potentially best-in-class clinical profile in previously treated advanced nonsquamous NSCLC. The duration of response is unprecedented and is combined with an impressive response rate in a one-time monotherapy for a difficult-to-treat patient population,” stated Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance. “We will pursue regulatory approvals for lifileucel monotherapy to effectively address the tens of thousands of patients with previously treated nonsquamous advanced NSCLC.”
Additional details on the interim data for IOV-LUN-202 are available here: https://ir.iovance.com/news-events/events-presentations.
About Non-Small Cell Lung Cancer
Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide, with an estimated 2.5 million new cases and 1.8 million deaths globally each year, and an estimated 226,000 new cases and 125,000 deaths in the U.S. each year.3,4 Approximately
About IOV-LUN-202
IOV-LUN-202 is a registrational, global phase 2 study investigating lifileucel monotherapy in patients with advanced (metastatic or unresectable) NSCLC without EGFR, ROS1 or ALK actionable genetic mutations and previously treated with an immune checkpoint inhibitor and chemotherapy. Enrollment is expected to be completed during the second half of 2026.
About TIL Cell Therapy
Tumor infiltrating lymphocytes (TIL) are naturally occurring immune cells that are on constant surveillance to recognize, attack and kill cancer cells. TIL cells recognize cancer through tumor markers on the surface of cancer cells that are unique to each person. The majority of solid tumor immune targets are patient-specific, with fewer than
TIL cell therapy is intended to reinvigorate and expand a patient’s TIL cells so they can be deployed to fight cancer. A patient’s naturally occurring TIL cells are collected from a portion of their own tumor and grown outside the body using Iovance’s proprietary manufacturing process. Individualized TIL therapy is a one-time treatment to deliver these cells back to the patient. Once inside the body, TIL cell therapy deploys billions of personalized, patient-specific TIL cells to recognize, target, and destroy diverse cancer cells.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. 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.
References
- Interim data cut as of October 10, 2025 of nonsquamous NSCLC patients with minimum cell dose based on FDA feedback.
- Ahn MJ et al. J Clin Onc 2024;43:260-272.
- World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2022.
- National Cancer Institute Surveillance, Epidemiology and End Results (SEER) Program. 2025 Estimates, Lung and Bronchus.
Forward-Looking Statements
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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, including Amtagvi, for which we have obtained U.S. Food and Drug Administration (“FDA”) approval, and Proleukin, for which we have obtained FDA and European Medicines Agency (“EMA”) approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, 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 FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results from ongoing clinical trials or cohorts, including interim results for the IOV-LUN-202 trial, 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 enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials) and our expected approval and commercial launch timelines may be delayed; 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 our restructuring plan and workforce reduction will not result in the intended benefits or savings; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to 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 pandemic; the effects of global and domestic geopolitical factors; 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.
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FAQ
What was the lifileucel objective response rate reported by Iovance (IOVA) on November 3, 2025?
How long was the median follow-up and what was the median duration of response for Iovance lifileucel (IOVA)?
When does Iovance expect to file a supplemental BLA and potentially launch lifileucel for NSCLC (IOVA)?
How did lifileucel safety change after IOV-LUN-202 regimen updates reported November 3, 2025?
How does lifileucel response compare to standard docetaxel in previously treated nonsquamous NSCLC?
