BioNTech Halts Further Development of Cancer Vaccine in Late-Stage Melanoma

BioNTech, the German pharmaceutical company known for its mRNA technology, has announced it will not pursue further clinical trials of its BNT111 cancer vaccine candidate in late-stage refractory melanoma. This decision, revealed at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, marks a significant shift in the company's oncology strategy.

Phase 2 Trial Results and Strategic Implications

The phase 2 study, which combined BNT111 with Regeneron's checkpoint inhibitor Libtayo, showed promising results in patients with unresectable stage 3 or 4 melanoma who had previously undergone PD-1 or PD-L1 therapy. Key findings include:

• An objective response rate (ORR) of 18.1% for the BNT111-Libtayo combination
• Median progression-free survival of 3.1 months
• 24-month progression-free survival rate of 24.9%
• Median overall survival of 20.7 months
• 24-month overall survival rate of 47.8%

Despite these results, which lead study author Paolo Ascierto, M.D., described as "statistically significant" compared to historical controls, BioNTech has decided to redirect its focus. A company spokesperson stated, "In line with our strategy, we are currently not planning further clinical trials with BNT111 in this late-stage, refractory disease setting."

Shifting Focus in Cancer Vaccine Development

BioNTech's decision reflects a broader strategic realignment within its FixVac mRNA platform. The company is now prioritizing other programs, including:

1. BNT116, another FixVac candidate being developed in partnership with Regeneron
2. BNT113, currently in a pivotal phase 2/3 study for certain head and neck cancer patients

This shift comes as part of BioNTech's August 2025 announcement to concentrate on mRNA cancer immunotherapies, individualized cancer therapy (iNeST), and other immuno-oncology approaches.

Industry-Wide Challenges in Melanoma Vaccine Development

BioNTech's move highlights the ongoing challenges in developing effective cancer vaccines, particularly for melanoma. Other companies facing similar hurdles include:

• Evaxion, whose personalized melanoma vaccine showed a 75% ORR but lacked statistical significance due to low enrollment
• Moderna, which is advancing an mRNA vaccine targeting PD-L1 and IDO antigens in PD-L1 positive melanoma tumors

As the pharmaceutical industry continues to grapple with these challenges, the focus on innovative approaches and strategic partnerships remains crucial in the pursuit of effective cancer treatments.