RE:RE:“Second mouse gets the cheese “Previous to BioNTech / Genentech's release of Phase 1 data with mRNA + atezolizumab combination Phase 1 data in the treatment of resectable pancreatic cancer at AACR24 this week, a Phase 2 study was initiated in combination with with mFOLFIRINOX, in October 2023.
An ongoing open-label, multicenter, randomized Phase 2 trial (NCT059668326), sponsored by Genentech in collaboration with BioNTech, was started in October 2023. The trial will investigate the efficacy and safety of adjuvant autogene cevumeran in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy compared with the current standard of care chemotherapy (mFOLFIRINOX) in patients with PDAC. The Phase 2 trial is currently enrolling patients at clinical trial sites in the United States, with additional sites planned to open globally. Autogene cevumeran is being jointly developed by BioNTech and Genentech and is currently being evaluated in three ongoing randomized Phase 2 clinical trials in adjuvant PDAC (as mentioned above), first-line melanoma, and adjuvant colorectal cancer.
https://investors.biontech.de/news-releases/news-release-details/three-year-phase-1-follow-data-mrna-based-individualized
The Phase 2 study is measuring disease-free survival as the primary endpoint while overall survival, disease-free survival rates, overall survival rate and safety profile will be the secondary endpoints of the trial. This Phase II trial was launched based on findings from a Phase I trial of autogene cevumeran plus atezolizumab and chemotherapy.
Phase I data showed an encouraging safety profile of the treatment with vaccine-elicited T-cell responses that may be linked to delayed relapse of PDAC.
https://www.clinicaltrialsarena.com/news/biontech-cancer-vaccine-trial/
https://www.mskcc.org/news/can-mrna-vaccines-fight-pancreatic-cancer-msk-clinical-researchers-are-trying-find-out