BNT111/Cemiplimab Combo Significantly Improves ORR in Unresectable Melanoma
Source: Cancer Network, August 2024
The safety profile of BNT111 plus cemiplimab was consistent with previous trials assessing BNT111 with anti–PD-L1 treatments.
Investigational mRNA cancer immunotherapy, BNT111, in combination with anti–PD-1 monoclonal antibody cemiplimab (Libtayo), has reached the primary end point of overall response rate (ORR) in a phase 2 clinical trial (NCT04526899) for patients with unresectable stage III or IV melanoma, according to a news release from the developer, BioNTech.
The combination therapy demonstrated a significant ORR improvement compared with historical control populations in this treatment setting and indication. Additionally, both randomized monotherapy arms showed meaningful activity. The ORR with cemiplimab alone was in line with historical control rates reported with anti–CTLA-4 and anti–PD-L1 treatments among this patient group. Treatment was well tolerated in the combination therapy arm, and the safety was consistent with previous trials assessing BNT111 with anti–PD-L1 treatments. Secondary end points were not mature as of primary analysis.