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Marco Donia: First Positive Phase 3 Trial of a Personalized Neoantigen Therapy in Cancer
Marco Donia/LinkedIn

Marco Donia: First Positive Phase 3 Trial of a Personalized Neoantigen Therapy in Cancer

Marco Donia, Professor at University of Copenhagen, shared on LinkedIn:

“The Phase 3 INTerpath-001 trial evaluated personalized neoantigen vaccine intismeran autogene (V940/mRNA-4157) + pembrolizumab vs pembrolizumab alone in 1,137 patients with completely resected stage IIB-IV cutaneous melanoma.

Key points (company-reported, full efficacy results are still not disclosed and not peer reviewed):

  • The trial met its primary Recurrence-Free Survival endpoint.
  • Distant Metastasis-Free Survival was also significantly improved.
  • No new safety signals were reported.
  • This is consistent with the positive signal previously seen in the Phase IIb trial.

Take-Home:

  • First positive Phase 3 results for an individualized neoantigen therapy in cancer, with efficacy observed on top of active anti-PD-1 therapy.
  • These results also support the broader development of personalized neoantigen vaccines, currently being investigated across multiple cancer types.

But some caution today: full data are still needed, including hazard ratios, absolute benefit, subgroup results and overall survival.

Marco Donia

Clinical Implications:

  • Potential new adjuvant option for high-risk resected melanoma.
  • However, for many patients with resectable macroscopic stage III melanoma, neoadjuvant immunotherapy has become a standard treatment approach. INTerpath-001 enrolled patients without prior systemic therapy.

Very important result. Looking forward to the full INTerpath-001 dataset.”

Title: Intismeran Autogene Plus Pembrolizumab Versus Pembrolizumab Alone in High-Risk Resected Melanoma: 5-Year Update of the Randomized Phase IIb KEYNOTE-942 Study

Authors: Adnan Khattak, Matteo S. Carlino, Tarek Meniawy, George Ansstas, Matthew H. Taylor, Kevin B. Kim, Meredith McKean, Georgina V. Long, Ryan J. Sullivan, Mark Faries, Thuy T. Tran, C. Lance Cowey, Andrew Pecora, Theresa Medina, Victoria Atkinson, Clemens Krepler, Thomas Jemielita, Huzhang Mao, Jacky Chow, Laureen S. Ojalvo, Janice M. Mehnert.

Read the full article.

You might be interested in: INTerpath-001 Trial: Personalized mRNA Cancer Vaccine for Melanoma

Marco Donia: First Positive Phase 3 Trial of a Personalized Neoantigen Therapy in Cancer

Adnan Khattak Andrew Pecora C. Lance Cowey cancer Clemens Krepler George Ansstas Georgina V. Long Huzhang Mao Jacky Chow Janice M. Mehnert Kevin B. Kim Laureen S. Ojalvo Mark Faries Matteo S Carlino Matthew H. Taylor Melanoma Meredith McKean Metastasis Free Survival neoadjuvant immunotherapy neoantigen vaccine OncoDaily Oncology pembrolizumab Ryan J Sullivan Tarek Meniawy Theresa Medina Thomas Jemielita Thuy T. Tran vaccine for melanoma Victoria Atkinson