IOVA - Iovance Biotherapeutics Announces Clinical Data in Frontline Advanced Melanoma at ASCO 2024 Annual Meeting | Benzinga
Lifileucel TIL Cell Therapy in Combination with Pembrolizumab Demonstrates
Deep, Durable Responses in Frontline Advanced Melanoma Patients
in IOV-COM-202 Clinical Study
ASCO Oral Presentation to Highlight 65% Objective Response Rate (ORR)
and 30% Complete Response Rate
Nearly All Responses Remain Ongoing at a
Median Follow-up of 21.7 Months in the Oral Presentation
Data in Published Abstract and Upcoming Oral Presentation
Strongly Support Ongoing TILVANCE-301 Phase 3 Trial
SAN CARLOS, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced updated clinical data for lifileucel in combination with pembrolizumab in frontline advanced melanoma, as well as translational data, for the upcoming 2024 ASCO Annual Meeting to be held May 31 – June 4, 2024, at McCormick Place in Chicago, IL and online.
Clinical Data in Frontline Advanced Melanoma (Cohort 1A in IOV-COM-202 Trial)
Positive results from Cohort 1A in the IOV-COM-202 trial were published in an abstract1 and will be highlighted in an upcoming oral presentation at ASCO. Unprecedented response rates, as well as deep and durable responses, were observed in patients with frontline advanced melanoma who were naïve to immune checkpoint inhibitor (ICI) therapy. These results strongly support the ongoing Phase 3 TILVANCE-301 clinical trial.
ASCO Oral Presentation Highlights
- A recent data cut included 23 patients with a median follow up of 21.7 months.2
- Confirmed ORR was 65.2%, including 7 (30.4%) complete responses and 8 (34.8%) partial responses by RECIST v1.1.
- All evaluable patients demonstrated regression of their target lesions.
- Nearly all responses remained ongoing. The duration of response was 12+ months for 8 responders (53.3%) and 6+ months for 11 responders (73.3%).
- As a one-time treatment, lifileucel's safety profile was differentiated from continuous ICI 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, stated, "The compelling response rates, including a 30.4% complete response rate, and depth and durability of responses for lifileucel in combination with pembrolizumab strongly support our strategy in frontline advanced melanoma. Expanding TIL cell therapy into earlier treatment settings is a top priority for Iovance. The positive data are highly encouraging for the anticipated ORR results in our ongoing TILVANCE-301 trial. A planned early interim analysis of ORR, a dual primary endpoint in TILVANCE-301, may support an accelerated approval in the frontline setting, with full approval supported by progression free survival."
The clinical and safety data from Cohort 1A continue to reinforce the rationale for the TILVANCE-301 trial. TILVANCE-301 is a global, randomized, registrational Phase 3 trial to support accelerated and full U.S. approvals of lifileucel in combination with pembrolizumab in frontline advanced melanoma. In addition, the ORR endpoint in TILVANCE-301 supports full approval of lifileucel monotherapy (Amtagvi™) in post-anti-PD-1 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 plans to conduct an early interim analysis of ORR as the potential basis for regulatory submission and approvals.
Iovance Presentation and Posters at ASCO Annual Meeting
- Oral Presentation: Efficacy and ...