BioNTech halts late-stage melanoma vaccine despite promising data

BioNTech is discontinuing development of its BNT111 cancer vaccine for advanced melanoma, despite a modest success in a phase 2 trial in combination with Regeneron's Libtayo.

Why it matters: The decision signals a strategic shift away from one of BioNTech’s earlier mRNA cancer vaccine candidates, even as the treatment showed potential, highlighting how companies are prioritizing programs with broader or more promising prospects.

Backstory: BioNTech and Regeneron began collaborating on this approach in 2020. BNT111, part of BioNTech’s FixVac platform, was tested in a phase 2 trial with Libtayo in patients with unresectable stage 3/4 melanoma who had relapsed after PD-1/PD-L1 therapies.

Zoom in: According to the new data released at ESMO over the weekend, the combo achieved an 18.1% objective response rate and extended median survival to 20.7 months, outperforming historical benchmarks. After 24 months, the combo was associated with a survival rate of 47.8% and a progression-free survival rate of 24.9%.

Big picture: Despite encouraging outcomes, BioNTech is pausing further clinical trials for BNT111 to focus on its broader cancer immunotherapy pipeline, including BNT116 and BNT113, along with its personalized iNeST program. This pivot underscores a trend in biotech to streamline pipelines toward therapies with the greatest commercial and clinical potential.