SAN CARLOS, Calif. - Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company specializing in novel cancer therapies, announced today that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the IOV-LUN-202 trial. This pivotal study is assessing the efficacy of LN-145, a tumor infiltrating lymphocyte (TIL) cell therapy, in treating non-small cell lung cancer (NSCLC).
The FDA had previously placed a partial hold on the trial, prompting Iovance to work with the agency and an independent data monitoring committee to implement additional safety measures and monitoring protocols. Following a review of these amendments, the FDA has authorized the continuation of patient enrollment for the study.
IOV-LUN-202 is specifically targeting advanced NSCLC patients who do not have EGFR, ROS, or ALK genomic mutations and have previously undergone chemotherapy and anti-PD-1 therapy. Those indicated by other actionable tumor mutations have also received at least one line of approved targeted therapy. Iovance anticipates completing the enrollment of approximately 120 patients in the registrational cohorts of the trial in 2025.
Preliminary results from the IOV-LUN-202 trial, initially reported in July 2023 and subsequently updated in November 2023, have indicated the potential for LN-145 TIL therapy to provide durable responses. In the updated analysis, 71% of the confirmed responders exhibited a response duration exceeding six months.
Iovance is committed to advancing TIL therapies for cancer treatment and is the company behind Amtagvi™, the first FDA-approved T cell therapy for a solid tumor indication. The company's approach focuses on harnessing the human immune system's ability to recognize and destroy cancer cells.
This news is based on a press release statement from Iovance Biotherapeutics, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.