Positive Clinical Data for Iovance Biotherapeutics in Melanoma

Iovance Biotherapeutics, Inc. has announced updated clinical data for lifileucel in combination with pembrolizumab in frontline advanced melanoma. The data, to be presented at the 2024 ASCO Annual Meeting, showcases positive results from cohort 1a in the iov-com-202 trial.

The recent data cut included 23 patients with a median follow-up of 21.7 months. The confirmed objective response rate (ORR) was 65.2%, including 30.4% complete responses and 34.8% partial responses by RECIST v1.1. Additionally, all evaluable patients demonstrated regression of their target lesions. The duration of response was 12+ months for 53.3% of responders and 6+ months for 73.3% of responders.

The safety profile of lifileucel as a one-time treatment was differentiated from continuous immune checkpoint inhibitor combination regimens. Treatment-emergent adverse events were consistent with the underlying disease and known safety profiles of pembrolizumab monotherapy, nonmyeloablative lymphodepletion, and interleukin-2.

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, emphasized the compelling response rates and depth and durability of responses for lifileucel in combination with pembrolizumab in frontline advanced melanoma. He highlighted that the positive data strongly support the strategy of expanding TIL cell therapy into earlier treatment settings.

The clinical and safety data from cohort 1a continue to reinforce the rationale for the ongoing phase 3 trial, TilVance-301, which aims to support accelerated and full U.S. approvals of lifileucel in combination with pembrolizumab in frontline advanced melanoma. The U.S. Food and Drug Administration (FDA) has agreed to the design of the TilVance-301 trial, including dual-primary endpoints of ORR and progression-free survival.

Iovance Biotherapeutics plans to conduct an early interim analysis of ORR as the potential basis for regulatory submission and approvals.

The company's oral presentation on the efficacy and safety of lifileucel and pembrolizumab in patients with immune checkpoint inhibitor-naive advanced melanoma, as well as posters on related topics, will be featured at the ASCO Annual Meeting. Additionally, an audio webcast will be held to discuss ASCO data highlights and perspectives on the Amtagvi commercial launch.

Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor-infiltrating lymphocyte (TIL) therapies for patients with cancer. Their commitment to continuous innovation in cell therapy, including gene-edited cell therapy, underscores their goal of extending and improving patients' lives. Following these announcements, the company's shares moved 0.4%, and are now trading at a price of $10.3. If you want to know more, read the company's complete 8-K report here.

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