LN-145 / Iovance Biotherap - LARVOL DELTA

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

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

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

New P2 trial • Genetic Disorders • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma (clinicaltrials.gov) - P2 | N=210 | Terminated | Sponsor: Iovance Biotherapeutics, Inc. | Trial completion date: Dec 2030 ➔ Aug 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Aug 2025; After reviewing available safety and efficacy data to date, Iovance concluded the study reached the required number of events for evaluation of study endpoints.

Trial completion date • Trial primary completion date • Trial termination • Cervical Cancer • Oncology • Solid Tumor

Efficacy and safety of one-time autologous tumor-infiltrating lymphocyte cell therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. (PubMed, J Immunother Cancer) - P2 | "This study demonstrated the feasibility of consistently generating sufficient TIL from HNSCC tumors. Results from this study suggest TIL cell therapy may serve as a potential treatment option for patients with HNSCC and support further development, including TIL cell therapy combined with immune checkpoint inhibitors or other agents or with other TIL products."

Journal • Tumor-infiltrating lymphocyte • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IL2 • PD-L1

Lifileucel Franchise in Solid Tumors: Priority Programs (GlobeNewswire) - "Iovance remains on track to share additional data in the second half of 2025 from the IOV-LUN-202 registrational Phase 2 trial to support a potential U.S. accelerated approval of lifileucel monotherapy in post-anti-PD-1 NSCLC in 2027....Iovance is actively enrolling in the IOV-END-201 Phase 2 trial for advanced endometrial cancer, a significant unmet medical need. The trial is investigating lifileucel after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status, with initial results on track for the second half of 2025."

FDA approval • P2 data • Endometrial Cancer • Non Small Cell Lung Cancer

NCI-2018-00918: LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jun 2025 ➔ Apr 2027 | Trial primary completion date: Jun 2025 ➔ Apr 2027

Platinum resistant • Trial completion date • Trial primary completion date • Breast Cancer • Carcinosarcoma • Endocrine Cancer • Giant Cell Tumor of Bone • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Osteosarcoma • Ovarian Cancer • Refractory Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • Triple Negative Breast Cancer • HER-2

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

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 | N=10 ➔ 20

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