RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Regenerative Medicine Advanced Therapy (United States), Fast Track (United States)

Clinical Trials associated with Lifileucel

NCT07288073

/ RecruitingPhase 2IIT

A Feasibility Study of Tumor Infiltrating Lymphocytes in Cutaneous Squamous Cell Carcinoma and Merkel Cell Carcinoma

The purpose of this research study is to test the safety and effectiveness of a tumor-infiltrating lymphocyte (TIL) cellular therapy, also called LN-145 or lifileucel, and chemotherapy in combination with Interleukin-2 (IL-2) to find out what effects, if any, the combination has on participants with Cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC) who were previously treated with immunotherapy.
The names of the study interventions involved in this study are:
* Tumor Infiltrating Lymphocytes (a type of cellular therapy)
* Fludarabine and Cyclophosphamide (types of standard of care chemotherapy drugs)
* Interleukin-2 (a type of recombinant, human glycoprotein)

Start Date10 Feb 2026

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT07288203

/ RecruitingPhase 2

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Melanoma

This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma

Start Date28 Nov 2025

Sponsor / Collaborator

Iovance Biotherapeutics, Inc.

CTIS2025-522427-10-00

/ Not yet recruitingPhase 2IIT

A phase 2, Multicenter Study of TILs Treatment in Germ Cell tumors: the ARES Study

Start Date01 Aug 2025

Sponsor / Collaborator-

100 Clinical Results associated with Lifileucel

100 Translational Medicine associated with Lifileucel

100 Patents (Medical) associated with Lifileucel

Literatures (Medical) associated with Lifileucel

01 Mar 2026·Transplantation and Cellular Therapy

Safety and Efficacy of Tumor-Infiltrating Lymphocyte Therapy with Reduced-Dose Lymphodepleting Conditioning in High-Risk Metastatic Melanoma Patients

Article

Author: Sondak, Vernon K ; Gonzalez, Rebecca M ; Yu, Michael ; Bailey, Hanna ; Eroglu, Zeynep ; Ali, Johannes ; Adams, Karla ; Mullinax, John ; Klinkova, Olga V ; Khushalani, Nikhil I ; Locke, Frederick L ; Tran, Nam ; Markowitz, Joseph ; Perez, Matthew C ; Kalos, Denise ; Vieira, Ella ; Gaskill, Eric E ; Chau, Jamie ; Gonzalez, Ricardo ; Pilon-Thomas, Shari ; Hall, MacLean S ; Zager, Jonathan S ; Jain, Michael ; Baldonado, Jobelle ; Kuriakose, Joel ; DiMaggio, Elizabeth ; Karapetyan, Lilit ; Beatty, Matthew ; Ward, Kimberly ; Brohl, Andrew S ; Mulé, James J ; Alomar, Mohammed E ; Rodriguez-Alfonso, Lianicet ; Tarhini, Ahmad A ; Sarnaik, Amod A ; Otteni, Christopher

Nonmyeloablative lymphodepleting chemotherapy (LDC) is a crucial component of tumor-infiltrating lymphocyte (TIL) therapy ensuring T cell engraftment and durable antitumor activity. High-intensity preconditioning with cyclophosphamide (Cy; 60 mg/kg/day for 2 days) and fludarabine (Flu; 25 mg/m²/day for 5 days) dosing is typically used. Given the toxicity related to LDC, we investigated the safety and efficacy of reduced-dose LDC followed by standard of care lifileucel and high-dose interleukin-2 (IL-2) in a select cohort of melanoma patients. Patients received reduced-dose LDC if they met one or more of the following inclusion criteria: age ≥70 years, recently treated brain metastases, bowel metastases, bleeding, or need for continuous antiplatelet or anticoagulation use. LDC was given as Cy 30 mg/kg/day for 2 days and Flu 25 mg/ m²/day for 5 days, followed by a lifileucel infusion on day 0 and IL-2 (maximum 6 doses). Safety was evaluated using CTCAE v5, and efficacy was reported using RECIST v1.1. We treated 17 patients, including 9 males (53%) and 8 females (47%) The median patient age was 66 years (range, 36 to 78 years). Five had been treated for brain metastases, 59% had a lactate dehydrogenase level ≥ upper limit of normal, and 35% had a BRAFv600 mutation. The median number of IL-2 doses administered was 5 (range, 1 to 6). IL-2 was discontinued owing to patient refusal (n = 1), hypotension requiring vasopressor therapy (n = 1), grade 4 hyponatremia (n = 1), infection (n = 1), atrial fibrillation (n = 1), tachycardia (n = 1), grade 3 transaminitis (n = 2), and a combination of tachycardia and/or weight gain, hypoxia, and rigors (n = 3). All patients achieved grade 4 lymphopenia with a median absolute lymphocyte count nadir of 0.005 k/µL. The most frequent grade ≥3 treatment-related adverse events were anemia (n = 12; 71%), thrombocytopenia (n = 8; 47%), and febrile neutropenia (n = 10; 59%), with a median absolute neutrophil count recovery of 7 days. No deaths occurred within 30 days of TIL infusion. Among 16 evaluable patients, the best response was partial response in 7 patients (44%), stable disease in 3 (18%), and progressive disease in 6 (38%). The median follow-up was 10 months (95% confidence interval [CI], 8.7 months to not reached [NR]), the median duration of response was NR, the median progression-free survival was 5.1 months (95% CI, 4.3 to NR), and the median overall survival was NR (95% CI, 10 months to NR). Our data indicate that reducing Cy allowed successful completion of TIL therapy in high-risk metastatic melanoma patients without an obvious detrimental effect on response rate. This is the first report demonstrating the safety and feasibility of using real-world objective risk stratification to deliver reduced-dose lymphodepletion prior to lifileucel infusion in high-risk patients with metastatic melanoma. These findings warrant further investigation in a prospective trial of high-risk patients with metastatic melanoma.

01 Jan 2026·Journal for ImmunoTherapy of Cancer

Cell therapy in sarcoma: current landscape and future directions

Review

Author: Sahin, Taha Koray ; Guven, Deniz Can ; Dizdar, Omer ; Thistlethwaite, Fiona ; Connolly, Elizabeth A ; Lim, Kok Haw Jonathan ; Germetaki, Theodora ; Akin, Serkan

Sarcomas are rare malignancies of mesenchymal origin, characterized by significant biological and clinical heterogeneity. Many subtypes demonstrate limited sensitivity to standard systemic treatments, including immune checkpoint inhibitors. Cell therapy has emerged as a promising strategy, with the potential of durable clinical responses seen with genetically-engineered T-cell receptor T-cell therapies (TCR-T) such as those targeting the cancer-testis antigen MAGE-A4 in synovial sarcoma, leading to the US Food and Drug Administration approval of afamitresgene autoleucel in 2024. This constituted only the second approval of a cell therapy in a solid tumor following lifileucel in melanoma and demonstrated the potential of cell therapies in sarcomas. This review provides the current landscape and growing potential of cell therapies in sarcomas, including TCR-T, chimeric antigen receptor-T cells, tumor-infiltrating lymphocytes, natural killer (NK) cells, and mesenchymal stromal cells. However, the broader application of these therapies is hindered by the lack of targetable sarcoma-restricted immunogenic epitopes, spatiotemporal intratumoral heterogeneity, and a profoundly immunosuppressive tumor microenvironment that impedes effector-cell trafficking, expansion and persistence. While cell therapies hold promise for integration into precision medicine approaches for sarcomas, their successful implementation will require careful evaluation of clinical feasibility, logistical considerations and cost-effectiveness to optimize patient outcomes.

01 Dec 2025·CURRENT PROBLEMS IN CANCER

Current perspectives on Lifileucel tumor-infiltrating lymphocyte therapy: A paradigm shift in immunotherapy

Review

Author: Anwar, Sirajudheen ; Rao Puppala, Eswara ; Kaur, Simran Deep ; Bedi, Neena ; Kumar, Nitesh ; Abubakar, Md ; Ahemad, Nafees ; Kapoor, Deepak N

Lifileucel, a tumor-infiltrating lymphocyte (TIL) therapy, provides renewed hope for individuals with advanced, treatment-resistant malignancies. This is a groundbreaking advancement in cancer immunotherapy. Revolutionizing the way the immune system fights cancer, this state-of-the-art cellular therapy takes advantage of TILs' innate capacity to target tumors. Lifileucel is an innovative medicine that is garnering attention in oncology. It has shown remarkable efficacy in clinical trials, assisting individuals unresponsive to other therapy in sustaining their responses and enhancing their survival rates. This paper provides a comprehensive overview of contemporary perspectives on Lifileucel, including its mechanism of action, clinical results, challenges and potential applicability to a broader spectrum of solid tumors. The Lifileucel concept has initiated a new epoch in personalized cancer therapy. This review offers a forward-looking perspective on the potential advancements and opportunities for establishing Lifileucel and TIL-based therapies as a cornerstone in cancer therapy.

165

News (Medical) associated with Lifileucel

01 Apr 2026

·www.prnewswire.com

The $578 Billion Regenerative Medicine Market Has a Manufacturing Problem. One Company Just Solved the First Step

Issued on behalf of Avaí Bio, Inc. USANewsGroup.com VANCOUVER, BC, March 31, 2026 /PRNewswire/ -- The FDA has approved more than 40 cell and gene therapy products. The regenerative medicine market is projected to reach $578 billion by 2033. Cell therapy alone surpassed $8.2 billion this year. And yet the central challenge of the entire sector remains unresolved: how do you manufacture living therapeutics at scale, consistently, and affordably? Every cell therapy company confronts the same bottleneck. You can discover a transformative biological mechanism in a lab. You can prove it works in a trial. But the moment you need to produce it reliably for thousands or millions of patients, you run into the manufacturing wall. The cells degrade. The immune system rejects them. The supply chain breaks. The companies that solve manufacturing are the ones that will capture the value in this market. That manufacturing challenge is driving some of the most important milestones in the sector right now. Prime Medicine (NASDAQ: PRME) is developing prime editing — a next-generation gene editing platform that rewrites DNA without cutting both strands, reducing the off-target risks that have haunted earlier CRISPR approaches. The technology promises more precise manufacturing of gene-corrected cells at scale. Madrigal Pharmaceuticals (NASDAQ: MDGL) presented two-year data showing its therapy Rezdiffra significantly improved liver stiffness and fibrosis biomarkers in patients with compensated MASH cirrhosis, demonstrating that manufactured biologics can deliver sustained, measurable reversal of chronic organ damage. Iovance Biotherapeutics (NASDAQ: IOVA) received FDA approval for Amtagvi, a tumor-infiltrating lymphocyte therapy for advanced melanoma — the first approved TIL therapy, which requires extracting and expanding a patient's own immune cells in a centralized manufacturing facility. It's a landmark approval, but it also highlights the manufacturing complexity: each treatment is custom-made from the patient's own tumor tissue. Denali Therapeutics (NASDAQ: DNLI) is advancing tividenofusp alfa for Hunter syndrome, with a PDUFA target date of April 2026 and Fast Track, Breakthrough Therapy, and Priority Medicines designations — a therapy that requires precise protein engineering and scaled biomanufacturing to cross the blood-brain barrier. Each of these companies is grappling with a version of the same problem: how do you turn a biological discovery into a manufactured product? The answer, increasingly, starts with a Master Cell Bank. Avaí Bio (OTCQB: AVAI) recently announced the initiation of manufacturing a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein, working alongside joint venture partner Austrianova through their shared entity, Klothonova. A Master Cell Bank is the GMP-compliant, fully characterized starting material for all downstream production — the foundation from which all working cell banks and final therapeutic products are derived. Without it, there is no path to commercial scale. What makes Avaí Bio's approach distinctive is the delivery mechanism. Austrianova's Cell-in-a-Box® encapsulation technology protects the therapeutic cells inside a biocompatible shell, allowing them to continuously secrete α-Klotho without triggering immune rejection. This eliminates the manufacturing and logistical burden of patient-specific autologous therapies — the cells are manufactured once and delivered as an off-the-shelf product. The technology is backed by over 50 peer-reviewed publications and decades of clinical development. Prof. Walter H. Gunzburg, Chairman of Austrianova, said: "MCBs are a prerequisite for the production of Cell-in-a-Box® encapsulated cell products. They provide the foundation for sustainable production and ensure they meet the highest quality standards." Avaí Bio's dual-program approach targets both the Klothonova α-Klotho anti-aging platform and the Insulinova diabetes program. Peer-reviewed research links α-Klotho to reduced risk of Alzheimer's, cardiovascular disease, and certain cancers, with natural levels declining approximately 50% after age 40. The addressable markets span Alzheimer's ($32.8 billion by 2033), cardiovascular disease (the world's leading cause of death), and kidney disease (850 million affected globally). The regenerative medicine market is heading toward $578 billion. The companies that will capture the lion's share of that value are the ones that can manufacture living therapeutics reliably and at scale. Avaí Bio (OTCQB: AVAI) just took the foundational manufacturing step — and it did so with a delivery platform that turns cell therapy from a custom procedure into a scalable product. For more information on Avaí Bio (OTCQB: AVAI) and its Klothonova and Insulinova programs, visit USANewsGroup.com Read this and more news for Avaí Bio at: USANewsGroup.com Article Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avaí Bio, Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Avaí Bio, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avaí Bio, Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avaí Bio, Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES: 1. Straits Research, Global Cell Therapy Market 2026 — 2. Precedence Research, Cell and Gene Therapy Market Forecast — 3. Grand View Research, CAR T-Cell Therapy Market — 4. Astute Analytica, Regenerative Medicine Market 2025–2033 — Logo - 21% more press release views with Request a Demo

Cell TherapyDrug ApprovalFast TrackGene Therapy

24 Mar 2026

·www.prnewswire.com

Advanced Cell-based Therapy Booming the Success for Healthcare Sector

Issued on behalf of Avaí Bio, Inc. VANCOUVER, BC, March 24, 2026 /PRNewswire/ -- USANewsGroup.com — The FDA has approved more than 40 cell and gene therapy products. The regenerative medicine market is projected to reach $578 billion by 2033. Cell therapy alone surpassed $8.2 billion this year. But every cell-based therapy — no matter how revolutionary the science — begins with the same foundational requirement: a reliable, standardized bank of cells to work from. Without that cellular starting material, there is no consistency, no scalability, and no path from laboratory discovery to therapeutic development. A Master Cell Bank (MCB) is the process of taking a single genetically engineered cell and cloning it into tens of millions of identical copies under GMP-compliant conditions. It's the foundational infrastructure that ensures every subsequent step in therapy development works from the same characterized, quality-controlled source. It's not the therapy itself — it's the prerequisite that makes therapy development possible. That distinction matters, because the companies advancing cell therapies right now are each navigating their own version of the journey from cellular science to clinical reality. Prime Medicine (NASDAQ: PRME) is developing prime editing — a next-generation gene editing platform that rewrites DNA without cutting both strands, reducing off-target risks that have haunted earlier CRISPR approaches. The precision is remarkable, but the path from edited cell to approved therapy is measured in years of development, trials, and manufacturing scale-up. Madrigal Pharmaceuticals (NASDAQ: MDGL) presented two-year data showing its therapy, Rezdiffra, significantly improved liver stiffness and fibrosis biomarkers in patients with compensated MASH cirrhosis — demonstrating that biological interventions can deliver sustained, measurable reversal of chronic organ damage. Iovance Biotherapeutics (NASDAQ: IOVA) received FDA approval for Amtagvi, the first approved tumor-infiltrating lymphocyte therapy for advanced melanoma. It's a landmark, but each treatment must be custom-manufactured from the individual patient's own tumor tissue — underscoring how critical scalable cellular infrastructure is to the future of the field. Denali Therapeutics (NASDAQ: DNLI) is advancing tividenofusp alfa for Hunter syndrome, with a PDUFA target date of April 2026 and multiple FDA designations, requiring precise protein engineering to cross the blood-brain barrier. Each of these programs illustrates the same truth: the distance between discovering a biological mechanism and delivering it to patients is defined by the quality of the cellular and manufacturing foundation underneath it. Avaí Bio (OTCQB: AVAI) recently announced the start of a key early-stage milestone alongside joint venture partner Austrianova: creating a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein. The MCB process clones a single engineered cell into tens of millions of identical copies, establishing the standardized cellular starting material from which all future working cell banks and therapy development for the Klothonova program will proceed. Prof. Walter H. Gunzburg, Chairman of Austrianova, said: "MCBs are a prerequisite for the production of Cell-in-a-Box® encapsulated cell products. They provide the foundation for sustainable production and ensure they meet the highest quality standards." The α-Klotho protein at the center of the Klothonova program is one of the most studied protective molecules in aging science. Peer-reviewed research links higher Klotho levels to reduced risk of Alzheimer's, cardiovascular disease, and certain cancers, while natural levels decline by approximately 50% after age 40. The addressable markets span Alzheimer's ($32.8 billion by 2033), cardiovascular disease (the world's leading cause of death), and kidney disease (850 million affected globally). Avaí Bio's dual-program approach also targets diabetes through the Insulinova platform, which, like Klothonova, leverages Austrianova's Cell-in-a-Box® encapsulation technology — a delivery system that protects therapeutic cells inside a biocompatible shell, allowing continuous protein secretion without immune rejection. The technology is backed by over 50 peer-reviewed publications. Every cell therapy begins with a single cell. The question is whether that cell has been properly characterized, cloned, and banked under the conditions required to support everything that comes after it. Avaí Bio (OTCQB: AVAI) just answered that question for its α-Klotho program — in a market heading toward $45 billion where the cellular foundation is what separates science from development. For more information on Avaí Bio (OTCQB: AVAI) and its Klothonova and Insulinova programs, visit USANewsGroup.com Read this and more news for Avaí Bio at: USANewsGroup.com Article Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avaí Bio, Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Avaí Bio, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avaí Bio, Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avaí Bio, Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES: Straits Research, Global Cell Therapy Market 2026 — Precedence Research, Cell and Gene Therapy Market Forecast — Grand View Research, CAR T-Cell Therapy Market — Astute Analytica, Regenerative Medicine Market 2025–2033 — Logo: 21% more press release views with Request a Demo

Cell TherapyDrug ApprovalGene TherapyImmunotherapy

23 Mar 2026

·www.biospace.com

Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4) - March 20, 2026

SAN CARLOS, Calif., March 20, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that on March 19, 2026 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 3,400 shares of Iovance’s common stock to one new, non-executive employee. The award was granted under Iovance’s Amended and Restated 2021 Inducement Plan, which was adopted on September 22, 2021 and amended and restated on January 12, 2022, March 13, 2023, February 26, 2024, and November 22, 2024, and provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $3.87, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (the “First Vesting Date”) and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates. 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 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. 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. CONTACTS Investors IR@iovance.com 650-260-7120 ext. 150 Media PR@iovance.com 650-260-7120 ext. 150

Drug ApprovalClinical Result

100 Deals associated with Lifileucel

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Melanoma	United States	Iovance Biotherapeutics, Inc.	16 Feb 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic melanoma	NDA/BLA	European Union	Iovance Biotherapeutics, Inc.	28 Jun 2024
Unresectable Melanoma	NDA/BLA	European Union	Iovance Biotherapeutics, Inc.	28 Jun 2024
Melanoma, Cutaneous Malignant	Phase 2	United States	Iovance Biotherapeutics, Inc.	28 Nov 2025
Melanoma, Cutaneous Malignant	Phase 2	Australia	Iovance Biotherapeutics, Inc.	28 Nov 2025
Melanoma, Cutaneous Malignant	Phase 2	Canada	Iovance Biotherapeutics, Inc.	28 Nov 2025
Melanoma, Cutaneous Malignant	Phase 2	United Kingdom	Iovance Biotherapeutics, Inc.	28 Nov 2025
Advanced Endometrial Carcinoma	Phase 2	United States	Iovance Biotherapeutics, Inc.	29 Oct 2024
Uterine Cervical Cancer	Phase 2	United States	Iovance Biotherapeutics, Inc.	21 Mar 2022
metastatic non-small cell lung cancer	Phase 2	United States	Iovance Biotherapeutics, Inc.	07 May 2019
metastatic non-small cell lung cancer	Phase 2	Canada	Iovance Biotherapeutics, Inc.	07 May 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Unresectable Melanoma	41	Lifileucel infusion (≤2 prior lines of therapy)	ooqakgrdiv(hxnggdposz) = esqshkcibl sjbggzyrfu (latwxhqumj )	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Unresectable Melanoma	41	Lifileucel infusion (≥3 prior lines of therapy)	ooqakgrdiv(hxnggdposz) = roztbplzcz sjbggzyrfu (latwxhqumj )	Positive	04 Feb 2026
NCT02360579 (LN-144 \| C-144–01 \| C-144-01, CTgov)	Phase 2	Metastatic melanoma	220	Lifileucel (Cohort 1)	pbppeibgds = repsbwvdug geufuapguj (fuiemnpwrc, pydlceugay - gdhirsixkq) View more	-	09 Dec 2025
NCT02360579 (LN-144 \| C-144–01 \| C-144-01, CTgov)	Phase 2	Metastatic melanoma	220	Lifileucel (Cohort 2)	pbppeibgds = gznbhyiiup geufuapguj (fuiemnpwrc, okeftlawph - eyxnjivnjp) View more	-	09 Dec 2025
NCT04614103 (IOV-LUN-202, Company_Website) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma	39	Lifileucel	xmwczsceek(ngchgzqbub) = agfzzrgoam gtulowrxxm (wypmmqqmme ) View more	Positive	03 Nov 2025
NCT02360579 (C-144-01, ESMO2025) Manual	Phase 2	Metastatic melanoma	106	Lifileucel	pnrbpwfgqk(zzwqczvrjg) = abdtcmzdyg ihdjurnagp (ucldzaglzx, 16.7 - 35.7) View more	Positive	17 Oct 2025
ESMO_IO2025	Not Applicable	Metastatic melanoma	13	Lifileucel (metastatic melanoma)	xpvxlrvbsw(wjqcqrnrfr) = yilibqqwbu qkstxpchqr (xuqezslnnk ) View more	Positive	12 Oct 2025
NEWS Manual	Not Applicable	Melanoma	41	Amtagvi(lifileucel)	emmmvwxyuj(sxdacpzfba) = jbmhyzsuxy owqgwoncuk (vejpdufvyu )	Positive	04 Aug 2025
NEWS Manual	Not Applicable	Melanoma	41	Amtagvi (早期患者(既往≤2线治疗))	emmmvwxyuj(sxdacpzfba) = ugpisvtchk owqgwoncuk (vejpdufvyu )	Positive	04 Aug 2025
NCT02360579 (C-144-01, ASCO2025) Manual	Phase 2	Melanoma	153	Lifileucel	plmecqraot(zgtofasiof) = gnaspjqieg hcigmhugzw (cezdxtyrba ) View more	Positive	30 May 2025
NCT03645928 (IOV-COM-202, SITC2024) Manual	Phase 2	metastatic non-small cell lung cancer Second line \| First line \| Third line	22	Lifileucel plus Pembrolizumab (EGFR -wt)	xlyzplxxvr(ynhpnkxmwy) = dmbvvrjbdw stabttsjrf (bmatyiyztt, 35.1 - 87.2) View more	Positive	05 Nov 2024
NCT03645928 (IOV-COM-202, SITC2024) Manual	Phase 2		22	Lifileucel plus Pembrolizumab (EGFR-mutation post-TKI)	xlyzplxxvr(ynhpnkxmwy) = scqbeifbsa stabttsjrf (bmatyiyztt )	Positive	05 Nov 2024
NCT03645928 (IOV-COM-202, Pubmed \| Cancer Discov) Manual	Phase 2	metastatic non-small cell lung cancer \| Advanced Lung Non-Small Cell Carcinoma	28	Lifileucel	ykrdicyfew(hqcgoalucl) = creipebteb zyhwzointd (uhuhhqblde ) View more	Positive	02 Aug 2024
NCT03645928 (IOV-COM-202, ASCO2024) Manual	Phase 3	Unresectable Melanoma BRAF mutation-positive	22	Lifileucel and Pembrolizumab (Stage IIIC to IV unresectable or metastatic melanoma + ≤ 3 prior lines of systemic therapy, excluding checkpoint inhibitors (CPI))	mlatihorqm(jnytzkezvh) = pvmdjnklfk crgiixzdrd (vlufyeywje )	Positive	24 May 2024

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