BNT111 Plus Cemiplimab Generates Responses in Unresectable Stage III/IV Melanoma
Source: OncLive, August 2024
BioNTech has announced positive topline findings from an ongoing phase 2 trial (NCT04526899) evaluating the investigational mRNA cancer immunotherapy BNT111 in combination with cemiplimab (Libtayo) for patients with unresectable stage III or IV melanoma who experienced disease progression following anti-PD-(L)1 therapy.
The study met its primary efficacy end point of objective response rate (ORR), showing a statistically significant improvement in ORR among patients who received BNT111 plus cemiplimab vs historical controls. Moreover, both monotherapy arms displayed clinical activity; the ORR in the cemiplimab monotherapy arm was comparable with historical controls of anti–PD-(L)1 or anti–CTLA-4 therapies in this patient population. The findings will be presented at an upcoming medical meeting and will also be submitted for publication in a peer-reviewed scientific journal.
“These phase 2 results mark a significant step towards our vision of personalized cancer medicine. We envision mRNA as a centerpiece in future treatment paradigms for cancer, helping to address unmet medical needs, such as for patients with anti-PD-(L)1 refractory or resistant melanoma,” Özlem Türeci, MD, chief medical officer and co-founder of BioNTech, said in a news release.1 “These data are a proof of concept for us in three dimensions. First, for our decade-long improved mRNA cancer vaccine technology that uses uridine mRNA chemistry, a non-coding backbone that is engineered for optimal translational performance and our proprietary lipoplex formulation for delivery. Second, for our computational approaches for selecting suitable tumor antigens for our cancer indication-specific FixVac platform candidates. Third, for our strategy to combine synergistic modalities, in this case BNT111, with an established immune checkpoint treatment.”