Iovance Biotherapeutics Reveals Advanced Melanoma Data at ASCO 2024

SAN CARLOS, Calif., May 23, 2024 — Iovance Biotherapeutics, Inc. has recently shared significant clinical updates regarding lifileucel, a tumor-infiltrating lymphocyte (TIL) therapy, in combination with pembrolizumab for the treatment of frontline advanced melanoma. These findings, which will be presented at the 2024 ASCO Annual Meeting, underline the effectiveness of this therapeutic combination.

Clinical Trial Success

The latest clinical data from the IOV-COM-202 trial, specifically Cohort 1A, demonstrates highly promising results for patients with advanced melanoma who have not previously undergone immune checkpoint inhibitor (ICI) therapy. Published in an abstract and soon to be highlighted in an oral presentation, these results indicate unprecedented response rates and sustained responses in this patient population. The trial outcomes are expected to support the ongoing TILVANCE-301 Phase 3 trial.

Detailed Findings

A recent data evaluation covered 23 patients with a median follow-up duration of 21.7 months. The study noted a confirmed objective response rate (ORR) of 65.2%, with 7 patients (30.4%) achieving complete responses and 8 patients (34.8%) showing partial responses as per RECIST v1.1 criteria. Impressively, nearly all responses remained durable, with 53.3% of responders maintaining a response for at least 12 months and 73.3% for at least 6 months. Furthermore, this single-dose treatment showcased a unique safety profile compared to continuous ICI combination therapies.

Safety and Adverse Events

The adverse events observed were consistent with the underlying disease and the known safety profiles of pembrolizumab monotherapy, nonmyeloablative lymphodepletion, and interleukin-2. This aligns with the expectations based on previous studies and known treatment effects.

Expert Insights

Dr. Friedrich Graf Finckenstein, Chief Medical Officer at Iovance, emphasized the significance of these results. He highlighted the high complete response rate and the depth and durability of responses, which strongly support the ongoing trial strategy. Dr. Finckenstein underscored the potential for expanding TIL cell therapy into earlier treatment settings and the encouraging data from the TILVANCE-301 trial, which may expedite regulatory approval processes.

Implications for Future Trials

The robust data from Cohort 1A reinforce the design and rationale behind the TILVANCE-301 trial. This global, randomized Phase 3 trial aims to secure accelerated and full U.S. approvals for lifileucel in combination with pembrolizumab for frontline advanced melanoma. Additionally, the ORR endpoint in this trial is intended to support the full approval of lifileucel monotherapy (marketed as Amtagvi™) in post-anti-PD-1 melanoma scenarios. The U.S. FDA has endorsed the trial design, including its dual-primary endpoints of ORR and progression-free survival, and an early interim analysis of ORR is planned to potentially fast-track regulatory submissions.

Upcoming ASCO Presentations

Iovance will present their findings at the 2024 ASCO Annual Meeting, specifically in the Melanoma/Skin Cancers session on May 31. The presentation will detail the efficacy and safety of lifileucel combined with pembrolizumab in patients not previously treated with ICIs. Additional poster presentations will cover the use of IOV-3001, a modified interleukin-2 fusion protein, and the dynamics of circulating cytokines and chemokines during and after TIL therapy with lifileucel in advanced melanoma patients.

Conclusion

Iovance Biotherapeutics continues to make significant strides in the field of cancer treatment through their innovative TIL therapies. The promising results from the latest trials bolster their commitment to transforming cancer care and offer hope for more effective treatments for advanced melanoma patients.

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