Ezra Cohen, Chief Medical Officer of Oncology at Tempus Labs, shared on LinkedIn:
“Interesting vaccine platform in pancreatic cancer. Benefit correlated with robust T cell response to the vaccine. Natural questions are why did some patients not have a robust response and how do we augment that response to maximize efficacy?”
Title: Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial
Authors: Ben George, Harshabad Singh, Craig E. Devoe, Vincent Chung, Peter J. Hosein, Andrew Hendifar, Dae Won Kim, Jennifer B. Valerin, Tanios Bekaii-Saab, Dana B. Cardin, Manuel Hidalgo, Pashtoon M. Kasi, Alexis D. Leal, Meredith Pelster, Naomi Fei, Colin D. Weekes, Mark H. O’Hara, Thomas J. George, Syed M. Kazmi, Jonathan D. Mizrahi, Suresh Nair, Martin Maiers, Thian Kheoh, Gianni Amato, Jino Xavier, Julia P. Snyder, Madison H. Milaszewski, Xavier Cabana-Puig, James R. Perry, Lisa K. McNeil, Esther Welkowsky, Peter C. DeMuth, Christopher M. Haqq, Shubham Pant, Zev A. Wainberg, Eileen M. O’Reilly.
Key Findings
- Primary endpoint not met: Median disease-free survival (DFS) was 23.8 months with camupepimut versus 21.2 months with observation (HR 0.85; P = 0.5329).
- Strong immune response: 98.9% (89/90) of evaluable vaccinated patients developed mKRAS-specific T-cell responses.
- Immune response associated with outcomes: Stronger mKRAS-specific T-cell responses were associated with longer DFS (HR 0.22; P less than 0.0001).
- Encouraging subgroup findings: Prespecified analyses suggested improved DFS among patients with negative baseline ctDNA (HR 0.51) and those without prior radiotherapy (HR 0.59).
- Favorable safety profile: Grade 3 or higher adverse events occurred in 10.4% of vaccinated patients versus 14.6% in the observation group.
Read the Full Article.
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