Amtagvi (lifileucel) / Iovance Biotherap - LARVOL DELTA

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for First Quarter 2025 (GlobeNewswire) - "The IOV-LUN-202 trial is intended to support a potential accelerated approval of lifileucel in post-anti-PD-1 NSCLC in the U.S., with an anticipated regulatory decision in 2027....Iovance is actively enrolling in the IOV-END-201 Phase 2 trial for advanced endometrial cancer, with initial results expected in the second half of 2025."

FDA approval • P2 data • Non Small Cell Lung Cancer

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for First Quarter 2025 (GlobeNewswire) - "2025 Regulatory Approvals for Amtagvi Expected in the UK, EU, and Canada....Named patient programs are planned outside the U.S. to provide early access to treatment prior to national reimbursement and are also expected to provide initial revenue from these markets. Additional regulatory submissions remain on track for Australia in the first half of 2025 and Switzerland in the second half of 2025."

Canada approval • EMA approval • Filing • MHRA approval • Melanoma

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for First Quarter 2025 (GlobeNewswire) - "Iovance currently owns approximately 280 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide exclusivity through at least 2042. This patent portfolio covers TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity for Amtagvi into 2038 and additional patent rights, including methods of treating melanoma and compositions and methods for potency assays, expected to provide exclusivity into 2039 and 2042, respectively."

Patent • Melanoma

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for First Quarter 2025 (GlobeNewswire) - "1Q25 Amtagvi Revenue: Product revenue from U.S. Amtagvi sales was $43.6 million, impacted by a reduction in capacity during annual scheduled maintenance at the iCTC. Production has resumed enabling full capacity for infusions in the second quarter 2025....1Q25 Proleukin Revenue: Product revenue also included $5.7 million in Proleukin sales, primarily reflecting clinical and manufacturing use after stocking at major U.S. wholesalers in 2024. Significant orders are expected in the current quarter."

Sales • Melanoma • Renal Cell Carcinoma • Urothelial Cancer

Use of lenvatinib as bridging therapy for patients undergoing treatment with lifileucel: a single institution experience (EADO-WCM 2025) - "All three were primarily refractory to ipilimumab/nivolumab after progressing on prior adjuvant PD-1 therapy. Limited signal of efficacy was seen in three patients with primary resistance to combination ICI therapy. Updated data including additional patients will be presented."

Clinical • Cardiovascular • Gastrointestinal Disorder • Melanoma • Oncology • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases • Solid Tumor

Beyond Checkpoint Inhibition: Keeping Therapeutic Options Open. (PubMed, Am Soc Clin Oncol Educ Book) - "Combination immune checkpoint inhibitor therapy (ICI) with ipilimumab (anti-cytotoxic T-lymphocyte-associated protein 4) + nivolumab (anti-PD-1) in untreated, metastatic melanoma has achieved a ten-year melanoma-specific survival of 52%...Addition of ipilimumab, relatlimab (anti-LAG3), or lenvatinib (VEGFR TKI) has minimal to modest efficacy...Recently, personalized, autologous tumor-infiltrating lymphocyte therapy has become a US Food and Drug Administration-approved second-line option; lifileucel demonstrates durable response (approximately 30%) in heavily pretreated, metastatic melanoma...As a therapy which is limited to patients who are HLA-A*02:01, T-cell receptor (TCR) engineered T cells (TCR-T) iterates on personalized adoptive cell transfer, and immune mobilizing monoclonal TCRs against cancer are CD3 bispecifics that bind glycoprotein 100 (tebentafusp, approved for metastatic uveal melanoma) or PRAME to activate T cells...ICI may be given with modified..."

Checkpoint inhibition • IO biomarker • Journal • Review • Eye Cancer • Immunology • Melanoma • Oncology • Solid Tumor • Transplantation • Uveal Melanoma • CTLA4 • HLA-A • NRAS • PRAME

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Eye Cancer • Liposarcoma • Melanoma • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • Uveal Melanoma

Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT02360579 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • Melanoma • Oncology • Solid Tumor

Outpatient treatment-related toxicity after hospital discharge among patients receiving lifileucel for advanced melanoma. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • Melanoma • Oncology • Solid Tumor

A phase Ib study to assess the safety and efficacy of autologous tumor infiltrating lymphocytes (lifileucel) with adjuvant pembrolizumab (PEMBRO) for treatment of immunotherapy naïve patients with high-risk clinical stage IIIb-d resectable melanoma (MEL). (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT06190249 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P1 data • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor

Phase 2, multicenter study of frontline maintenance therapy with lifileucel plus pembrolizumab in advanced non-small cell lung cancer. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT03645928 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc.

New P1/2 trial • Eye Cancer • Melanoma • Ocular Melanoma • Oncology • Solid Tumor

Iovance Biotherapeutics Announces Participation in Upcoming Scientific Congresses (GlobeNewswire) - "Iovance Biotherapeutics...announced that pre-clinical data for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy, will be presented at the 2025 AACR Annual Meeting. In addition, five-year outcomes data from the C-144-01 study of lifileucel monotherapy in patients with advanced melanoma, and a poster on study design for lifileucel in frontline advanced non-small cell lung cancer, will be presented at the 2025 ASCO Annual Meeting."

Clinical protocol • P2 data • Preclinical • Melanoma • Non Small Cell Lung Cancer

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=245 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | N=178 ➔ 245

Enrollment change • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Nursing Considerations in Coordination of TIL therapy (ONS 2025) - "Our cancer center has been accepting both internal and external patient referrals as well as patient self-referrals for Amtagvi therapy. We are able to quickly assess patient records, navigate them to new patient appointments, work with the medical oncologist treating with Amtagvi, coordinate clearance testing (cardiac, pulmonary, labs), work with insurance coordinators, educate patients, refer patients for surgical consults, and adequately have patients prepare to receive Amtagvi therapy. As cellular therapies begin to be more available for solid tumor malignancies (clinical trials are underway in many cancer types) more oncology nurses will need to be trained and confident in navigating patients through the process of cell collection and/or tumor resection, communicating with commercial manufacturing companies, managing patient expectations on timing of therapy and patient/caregiver education."

Melanoma • Oncology • Solid Tumor

Solid tumour cellular therapy - principles of toxicity management. (PubMed, Immunooncol Technol) - "Extrapolating from experience with CAR T in the field of haemato-oncology, coupled with the historical use of high-dose interleukin-2 in solid tumour therapeutic regimens and more recently lifileucel and afami-cel, has led to the development of core principles for managing toxicity, which is discussed here. Looking to the future, a rapidly developing field with next-generation ACT products, a basic knowledge of such core principles will be an important foundation for healthcare professionals working in this space."

Adverse events • Journal • Review • Melanoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma

Dissected Duplicated Origin of Left Vertebral Artery as a Rare Cause of Recurrent Posterior Circulation Stroke (P3-14.012). (PubMed, Neurology) - "He was on mono antiplatelet treatment after first stroke (14 months prior), dual antiplatelet treatment (2 months prior) and apixaban with dual antiplatelet treatment after third stroke (one month prior)...Jovin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Contego Medical...Dr. Patel has nothing to disclose."

Journal • Cardiovascular • Ischemic stroke

Expanding the Therapeutic Reach of Chimeric Antigen Receptor T-Cells and Bispecific T-Cell Engagers Across Solid Tumors. (PubMed, JCO Precis Oncol) - "In this review, we discuss the landmark data that led to the commercialization of four novel FDA-approved T-cell-based therapeutics in solid malignancies, including tarlatamab for small cell lung cancer, afamitresgene autoleucel for synovial sarcoma, lifileucel for metastatic melanoma, and tebentafusp for metastatic uveal melanoma...Some solutions include addressing on-target, off-tumor toxicity; improving the manufacturing of CARs; optimizing the tissue-specific tumor microenvironment by combating immune desert tumors; and discovering natural tumor neoantigens and non-self-epitopes generated by tumor-specific mutations. These concepts can help provide transformative benefits for patients with solid malignancies in the coming years."

IO biomarker • Journal • Review • Brain Cancer • Breast Cancer • CNS Tumor • Eye Cancer • Genito-urinary Cancer • Glioblastoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Neuroblastoma • Oncology • Prostate Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Synovial Sarcoma • Uveal Melanoma • HER-2 • IL13RA2 • PSCA

Lifileucel (AMTAGVI) tumor-infiltrating lymphocyte morphology in CellaVision peripheral smear reviews. (PubMed, J Hematop) - No abstract available

Journal • Tumor-infiltrating lymphocyte • Oncology

Entering a new era of tumor-infiltrating lymphocyte cell therapy innovation. (PubMed, Cytotherapy) - "In February 2024, lifileucel became the first TIL cell therapy to be approved by the FDA and is indicated for adult patients with advanced melanoma...Several investigational TIL cell therapy products are in preclinical and early clinical development and are applying novel technologies to overcome key challenges. Herein, we summarize the current state of TIL cell therapy and highlight innovations that may reshape its future."

Journal • Review • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor

Efficacy and safety of lifileucel, an autologous tumor-infiltrating lymphocyte cell therapy, and pembrolizumab in patients with immune checkpoint inhibitor-naive unresectable or metastatic melanoma: updated results from IOV-COM-202 Cohort 1A (EADO-WCM 2025) - P2, P3 | "Treatment regimen consists of pembrolizumab, nonmyeloablative lymphodepletion (cyclophosphamide and fludarabine), a single lifileucel infusion (1×109– 150×109 cells), followed by up to 6 doses of IL-2 (600, 000 IU/kg IV), and continued pembrolizumab until disease progression, unacceptable toxicity, or up to 24 months. Late AEs were consistent with anti–PD-1 monotherapy and were differentiated from ICI combination therapies. Conclusions These results support further evaluation of lifileucel and pembrolizumab as frontline treatment for advanced melanoma in the phase 3 TILVANCE-301 study (NCT05727904)."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor

Optimizing TIL therapy for uveal melanoma: lessons learned and unlearned from cutaneous melanoma. (PubMed, Immunotherapy) - "The United States Food and Drug Administration approved lifileucel in 2024 as the first autologous TIL product for patients with advanced cutaneous melanoma (CM), adding to the list of approved immunotherapies for this highly immunogenic cancer...In this review, we describe the historical development of TIL-ACT, summarize the clinical results in advanced CM, and describe the novel application of TIL-ACT to metastatic uveal melanoma (UM), a prototypic immunotherapy-resistant solid tumor. We will highlight key biologic differences between CM and UM, their consequential influence on the manufacturing of UM-specific TIL products, and the development of novel biomarkers for precision TIL-ACT for metastatic UM."

IO biomarker • Journal • Review • Tumor mutational burden • Cutaneous Melanoma • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • TMB

Tumor-Infiltrating Lymphocyte Therapy for Melanoma: Nursing Considerations. (PubMed, Clin J Oncol Nurs) - "Clinicians have used commercially available cellular therapy to treat hematologic malignancies since 2017. In February 2024, the U.S. Food and Drug Administration approved the first commercial cellular therapy-lifileucel, a."

Journal • Tumor-infiltrating lymphocyte • Hematological Disorders • Hematological Malignancies • Melanoma • Oncology • Solid Tumor

The Clinical TIL Experience in Melanoma: Past, Present, Future. (PubMed, Transplant Cell Ther) - "The recent approval of lifileucel by the US Food and Drug Administration in February 2024 was the culmination of over 3 decades of research in adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) for unresectable melanoma. In this review, we highlight key historical data for TIL therapy in melanoma as well as ongoing efforts to improve its efficacy and applicability."

Journal • Review • Melanoma • Oncology • Solid Tumor

Tumor-Infiltrating Lymphocyte Therapy for Melanoma and Other Solid Tumors: Looking Back, Yet Moving Forward. (PubMed, Transplant Cell Ther) - "Lifileucel, the first solid tumor adoptive tumor infiltrating lymphocyte (TIL) therapy product to receive regulatory approval in advanced melanoma, represents a critical achievement in the pursuit of improving outcomes using cellular therapies in patients with solid tumors. This review traces the development of adoptive TIL therapy from the initial human studies in melanoma, through recent advances in studies of other solid tumors, and previews ongoing and future areas for preclinical and clinical advances to improve upon this novel therapeutic strategy."

Journal • Review • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor