LN-145 / Iovance Biotherap - LARVOL DELTA

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

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

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

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

Iovance Biotherapeutics reports third quarter 2018 financial results and provides corporate update (GlobeNewswire) - "Iovance received the Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel, the company’s adoptive cell therapy using its TIL technology for the treatment of patients with metastatic melanoma from the U.S. Food and Drug Administration (FDA); Enrollment in Cohort 2 of the global Phase 2 lifileucel metastatic melanoma study, C-144-01, reached the predefined sample size and was therefore closed...Patient enrollment in a new cohort, Cohort 4, will be initiated in early 2019; Patient dosing continues in the C-145-04 study [LN-145] for cervical carcinoma. The company recently dosed its first patient in Europe...Iovance anticipates providing an update on this study at an upcoming medical meeting in 2019;"

Enrollment closed • FDA event • P2 data • Trial status • Cervical Cancer • Melanoma • Oncology

Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc.

New P1 trial • Brain Cancer • CNS Tumor • Ewing Sarcoma • Melanoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

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 primary completion date: Jun 2024 ➔ Jun 2025 | Trial completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Breast Cancer • 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 • CD27 • CD28 • CD8 • HER-2

IOV-LUN-202: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | Trial completion date: Dec 2026 ➔ Dec 2031 | Trial primary completion date: Jun 2024 ➔ Dec 2030

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

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

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

Iovance Biotherapeutics Announces FDA has Lifted Clinical Hold on the IOV-LUN-202 Registrational Trial in Non-Small Cell Lung Cancer (GlobeNewswire) - "Iovance Biotherapeutics...announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on the registrational IOV-LUN-202 trial investigating LN-145 TIL cell therapy in non-small cell lung cancer (NSCLC). In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety measures and monitoring. Upon reviewing this proposal, the FDA has cleared Iovance to resume patient enrollment in IOV-LUN-202....Iovance expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025."

Enrollment status • FDA event • Non Small Cell Lung Cancer

Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=6 | Completed | Sponsor: Yale University | Trial completion date: Jan 2023 ➔ May 2023

Metastases • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

Iovance Biotherapeutics Announces Clinical Program Update for LN-145 in Non-Small Cell Lung Cancer (GlobeNewswire) - "Iovance Biotherapeutics, Inc...announced a clinical program update for LN-145 TIL therapy in non-small lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) placed a clinical hold on the IOV-LUN-202 trial on December 22, 2023, in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen....The clinical hold for IOV-LUN-202 has no impact on any other Iovance clinical trials and is independent of the FDA’s Priority Review of the biologics license application (BLA) for lifileucel in advanced melanoma. The BLA remains on track toward the Prescription Drug User Fee Act (PDUFA) action date of February 24, 2024. Iovance will pause enrollment and the LN-145 TIL treatment regimen for new patients in IOV-LUN-202 during the clinical hold."

BLA • PDUFA date • Trial suspension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IOV-LUN-202: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) - P2 | N=170 | Recruiting | Sponsor: Iovance Biotherapeutics, Inc. | N=95 ➔ 170

Enrollment change • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck (clinicaltrials.gov) - P2 | N=64 | Completed | Sponsor: Iovance Biotherapeutics, Inc. | N=112 ➔ 64

Enrollment change • Metastases • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (clinicaltrials.gov) - P2 | N=6 | Completed | Sponsor: Yale University | Active, not recruiting ➔ Completed | Trial completion date: Jul 2023 ➔ Jan 2023 | Trial primary completion date: Jul 2023 ➔ Jan 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

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 | Recruiting ➔ Active, not recruiting | N=95 ➔ 30

Enrollment change • Enrollment closed • Breast Cancer • 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

Iovance Biotherapeutics to Present Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapy at IASLC 2023 World Conference on Lung Cancer (GlobeNewswire) - "Iovance Biotherapeutics...announced oral and poster presentations reporting clinical and preclinical data for tumor infiltrating lymphocyte (TIL) therapies at IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Singapore, September 9-12, 2023."

P2 data • Preclinical • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Iovance Biotherapeutics Announces Regulatory and Clinical Updates for TIL Therapy in Advanced Non-Small Cell Lung Cancer (GlobeNewswire) - "As previously announced, Iovance is also preparing to meet with the FDA this year to discuss a randomized confirmatory trial of LN-145 in frontline advanced NSCLC patients. This confirmatory trial in frontline advanced NSCLC is expected to be well underway at the time of a potential approval in advanced post-anti-PD-1 NSCLC."

FDA event • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Iovance Biotherapeutics Announces Regulatory and Clinical Updates for TIL Therapy in Advanced Non-Small Cell Lung Cancer (GlobeNewswire) - P2 | N=95 | NCT04614103 | Sponsor: Iovance Biotherapeutics, Inc. | "At a Type B Pre-Phase 3 meeting held between Iovance and the U.S. Food and Drug Administration (FDA), the FDA provided positive regulatory feedback that the design of the IOV-LUN-202 trial may be acceptable for accelerated approval of LN-145 TIL therapy for patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) NSCLC without EGFR, ROS or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations....An ORR of 26.1% by RECIST v1.1 (n=6, one complete response and five partial responses) was observed, with a disease control rate of 82.6%. While still early on study, the median duration of response (DOR) was not reached. The DOR ranged from 1.4+ months to 9.7+ months....Enrollment is expected to be complete during the second half of 2024."

Enrollment status • FDA event • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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=95 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial primary completion date • Breast Cancer • 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