LN-145 / Iovance Biotherap - LARVOL DELTA

Lifileucel, an Autologous Tumor-infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors. (PubMed, Cancer Discov) - "In this phase 2 multicenter study, we evaluated the efficacy and safety of lifileucel (LN-145), an autologous tumor-infiltrating lymphocyte cell therapy, in patients with metastatic non-small cell lung cancer (mNSCLC) who had received prior immunotherapy and progressed on their most recent therapy. Two patients died of treatment-emergent adverse events: cardiac failure and multiple organ failure. Lifileucel is a potential treatment option for patients with mNSCLC refractory to prior therapy."

Checkpoint inhibition • Clinical • IO biomarker • Journal • Metastases • Monotherapy • Tumor mutational burden • Tumor-infiltrating lymphocyte • Cardiovascular • Congestive Heart Failure • Heart Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • STK11 • TMB

'SARATOGA': A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Soft Tissue Sarcoma (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Iovance Biotherapeutics, Inc.

New P2 trial • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | N=30 ➔ 40

Enrollment change • Angiosarcoma • Eye Cancer • Liposarcoma • Melanoma • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • Uveal Melanoma

A pilot study of autologous tumor-infiltrating lymphocytes (LN-145) in adult patients with undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma. (ASCO 2026) - P1 | "LN-144 (lifileucel), an autologous TIL product derived from unresectable or metastatic melanoma, was shown to have an overall response rate (ORR) of 36% in heavily pretreated melanoma patients with a median DOR of 19.7 months...Patients then underwent nonmyeloablative lymphodepletion with cyclophosphamide (60 mg/kg x 2 doses) and fludarabine (25 mg/m2 x 5 doses)...Safety and efficacy measures will be summarized using point estimates and a Clopper Pearson exact confidence interval will be used. The final results of the primary feasibility and safety endpoints and secondary feasibility endpoint for the first 10 enrolled patients as well as and preliminary secondary efficacy and exploratory correlative studies through week 12 for 7 treated patients will be reported as late-breaking abstract after data lock on March 1, 2026."

Clinical • Tumor-infiltrating lymphocyte • Liposarcoma • Non-melanoma Skin Cancer • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • IL2

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: May 2026 ➔ May 2027 | Trial primary completion date: May 2026 ➔ May 2027

Trial completion date • Trial primary completion date • Eye Cancer • Liposarcoma • Melanoma • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • Uveal Melanoma • ALK • BRAF • EGFR • ROS1

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=225 | Terminated | Sponsor: Iovance Biotherapeutics, Inc. | Trial completion date: Aug 2029 ➔ Feb 2026 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2029 ➔ Feb 2026; After reviewing the available safety and efficacy data to date, Iovance concluded that the study reached the required number of events for evaluation of study endpoints.

Trial completion date • Trial primary completion date • Trial termination • 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 • ALK • ROS1

IOV-LUN-202: initial results in previously treated, metastatic non-squamous NSCLC supported FDA Fast Track Designation, reflecting the high unmet medical need in this population. (The Manila Times) - "Upcoming milestones include: Updated data at a major medical meeting in 2026; Completion of enrollment in 2026 to support a supplemental Biologics License Application (sBLA); Potential for a U.S. accelerated approval and launch in the second half of 2027."

Enrollment status • FDA approval • Launch US • P2 data • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer

IOV-PED-101: Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • CNS Tumor • Ewing Sarcoma • Melanoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | N=48 ➔ 75

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 • Thoracic Cancer

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=178 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Trial completion date: Dec 2024 ➔ Aug 2029 | Trial primary completion date: Dec 2023 ➔ Aug 2029

Trial completion date • Trial primary completion date • 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

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | N=75 ➔ 135

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

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients with Cervical Carcinoma (clinicaltrials.gov) - P2 | N=47 | Recruiting | Sponsor: Lion Biotechnologies

Metastases • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | N=36 ➔ 48

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 • Thoracic 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

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Iovance Biotherapeutics, Inc.

New P2 trial • Melanoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma (clinicaltrials.gov) - P2 | N=189 | Active, not recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cervical Cancer • Oncology • Solid Tumor

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • 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 • Thoracic Cancer

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients with Cervical Carcinoma (clinicaltrials.gov) - P2 | N=47 | Recruiting | Sponsor: Lion Biotechnologies | Trial primary completion date: May 2020 ➔ Jun 2019

Metastases • Cervical Cancer • Gynecologic Cancers

IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=178 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | N=135 ➔ 178

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

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma (clinicaltrials.gov) - P2 | N=59 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Trial completion date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2019 ➔ Mar 2020

Trial completion date • Trial primary completion date • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma (clinicaltrials.gov) - P2 | N=47 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2019 ➔ Dec 2019

Trial completion date • Trial primary completion date • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma (clinicaltrials.gov) - P2 | N=189 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | N=138 ➔ 189 | Trial completion date: Dec 2026 ➔ Dec 2030 | Trial primary completion date: Dec 2021 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma (clinicaltrials.gov) - P2 | N=138 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | N=75 ➔ 138 | Trial completion date: Sep 2024 ➔ Dec 2026 | Trial primary completion date: Mar 2020 ➔ Dec 2021

Enrollment change • Trial completion date • Trial primary completion date • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

TIL Therapy in cSCC and MCC (clinicaltrials.gov) - P2 | N=14 | Recruiting | Sponsor: Karam Khaddour, MD, MS | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | N=20 ➔ 30

Enrollment change • Eye Cancer • Liposarcoma • Melanoma • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • Uveal Melanoma • ALK • BRAF • EGFR • ROS1