--- title: 'Clinical Daily Summary: What Happened on October 14, 2026' headline: BioNTech cancer vaccine misses progression-free survival goal description: A prostate cancer combination showed greater toxicity without a significant PSA-response gain. Calluna finished dosing in an IPF study. url: https://thebench.bio/news/clinical/2026-10-14 topic: clinical date: '2026-10-14' covers: - '2026-10-14' date_published: '2026-10-14T12:01:55Z' date_modified: '2026-10-14T12:01:55Z' tags: - Clinical sources: 4 publisher: TheBench.Bio --- # Clinical Daily Summary: What Happened on October 14, 2026 **BioNTech cancer vaccine misses progression-free survival goal** A prostate cancer combination showed greater toxicity without a significant PSA-response gain. Calluna finished dosing in an IPF study. ## Today in brief BioNTech’s BNT113 plus pembrolizumab did not significantly improve progression-free survival in a Phase 2/3 trial of HPV16-positive head and neck cancer. [1] [2] The study will continue to assess overall survival, its other primary endpoint. [1] [2] In a 54-patient Phase 2 prostate cancer trial, talazoparib plus enzalutamide did not significantly improve PSA response and caused more severe adverse events. [3] Calluna Pharma completed dosing in its 161-participant Phase 2 AURORA trial of CAL101 for idiopathic pulmonary fibrosis. Topline results are scheduled for the first quarter of 2027. [4] ## BioNTech’s BNT113 misses a trial endpoint, but survival analysis continues In AHEAD-MERIT, BNT113 plus pembrolizumab did not significantly improve progression-free survival over pembrolizumab alone. [1] [2] The trial tests the combination as an initial treatment for some patients with HPV16-positive head and neck cancer. [1] Progression-free survival was one of the trial’s two primary endpoints. The data monitoring committee recommended continuing the study to assess overall survival. [2] Under the trial’s statistical design, a significant overall-survival benefit could still count as a positive result. [2] BNT113 is an off-the-shelf messenger RNA vaccine encoding HPV16 proteins E6 and E7, intended to prompt a T-cell response against cancer cells. [1] ## Also worth knowing - In the 54-patient ZZ-FIRST Phase 2 trial, PSA response at 12 months was 73% with talazoparib plus enzalutamide and 64.7% with enzalutamide alone. The difference was not statistically significant. [3] - Grade 3 or higher adverse events affected 68% of combination-arm patients and 35% of control-arm patients. Two combination-arm patients died from treatment-emergent myeloid neoplasms. [3] ## The day in numbers - **68% vs. 35%**: Share of patients with grade 3 or higher adverse events in the prostate cancer trial’s combination and control arms. [3] - **161**: Participants in Calluna’s AURORA trial whose safety data were reviewed by the independent committee. [4] ## Also published - [Trials to watch: First cancer vaccine success could trigger a domino effect](), Clinical Trials Arena - [AATec is pioneering a new ­approach to lung diseases](), European Biotechnology - [Personalized neoantigen-targeting cancer vaccines in ovarian cancer: a phase 1 trial](), Nature Medicine - [BioNTech mRNA cancer immunotherapy misses first objective in key study](), BioPharma Dive - [BioNTech sticks with cancer vaccine despite trial miss](), pharmaphorum ## Sources 1. [BioNTech’s mRNA cancer vaccine misses Phase 2/3 endpoint](), European Biotechnology, 2026-10-14 2. [BioNTech misses PFS endpoints in Phase II/III cancer vaccine trial](), Clinical Trials Arena, 2026-10-13 3. [Talazoparib plus enzalutamide in high-volume metastatic hormone-naive prostate cancer: a randomized phase 2 trial](), Nature Medicine, 2026-10-14 4. [Dosing completed in Calluna Pharma’s Phase II AURORA trial](), Clinical Trials Arena, 2026-10-14 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: