Biotech clinical news summary, 14 October

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

N
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
N
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

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

The day in numbers

68%

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