Abstract 155P
Background
BNT113 is an IV administered liposomal ribonucleic acid (RNA-LPX) cancer vaccine encoding the human papillomavirus (HPV)16 oncoproteins E6 and E7. Preclinically, PD-L1 inhibition augments the anti-tumor effect of RNA-LPX-based vaccines, supporting combining BNT113 + pembrolizumab.
Methods
AHEAD-MERIT is an open-label, randomized, phase II trial of pembrolizumab (q3w) vs pembrolizumab + BNT113 (8xq1w, then q3w) as first-line treatment in patients (pts) with unresectable recurrent/metastatic HPV16 and PD-L1 positive HNSCC. Following a safety run-in of BNT113 + pembrolizumab, pts are randomized 1:1 to BNT113 + pembrolizumab or pembrolizumab. Primary endpoints: safety, OS, and ORR.
Results
As of 05 July 2022, of 15 treated pts, 12 had completed the safety run-in (pembrolizumab + 4 BNT113 doses). In the treated pts, the median age was 66 yrs (range: 41–74) and all were male. All pts in the safety run-in had ≥1 AE, the most frequent were pyrexia (8 pts) and chills (6 pts). There were 3 pts (25%) that had Grade ≥3 AEs with all classed as SAEs (pyrexia, hypercalcemia, pleural effusion, shaking/rigors). In 2/3 pts, the AEs (pyrexia, shaking/rigors) were considered related. No deaths were reported.
Conclusions
Safety was acceptable and in line with the safety profile of BNT113 and pembrolizumab as single agents; no new safety signals were observed for the combination. The randomized part of the trial is ongoing.
Clinical trial identification
BNT113-01: NCT04534205; EudraCT: 2020-001400-41.
Editorial acknowledgement
The authors would like to acknowledge Frank Smeets for clinical trial support and Camilla West (BioNTech SE) for medical writing support.
Legal entity responsible for the study
BioNTech SE.
Funding
BioNTech SE.
Disclosure
K. Klinghammer: Financial Interests, Personal and Institutional, Advisory Role: MSD, Merck, Roche, Novartis, BMS; Financial Interests, Personal and Institutional, Other, Travel, accommodation, expenses: Merck, BMS. N.F. Saba: Financial Interests, Personal and Institutional, Advisory Role: Pfizer, Merck, GlaxoSmithKlein; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Funding: Exilexis. E. Castelluci: Other, Institutional, Principal Investigator: IO Biotech, Adlai Nortye USA, ECOG-ACRIN, ETCTN, BioNTech SE. A.D. Colevas: Other, Institutional, Other, Support for clinical trial: BioNTech SE. T. Rutkowski: Other, Personal, Principal Investigator: BioNTech SE. R. Greil: Financial Interests, Personal, Advisory Role: Celgene, Novartis, Roche, BMS, Takeda, AbbVie, AstraZeneca, Jannssen, MSD, Merck, Gilead, Daiichi Sankyo, Sanofi; Financial Interests, Institutional, Funding: Celgene, Roche, Merck, Takeda, AstraZeneca, Novartis, Amgen, BMS, MSD, Sandoz, AbbVie, Gilead, Daiichi Sankyo. D. Thurner: Financial Interests, Personal, Advisory Board: MSD, Merck. U. Müller-Richter: Non-Financial Interests, Personal, Advisory Board: BMS, MSD, Sanofi, Merck; Non-Financial Interests, Personal, Invited Speaker: BMS, MSD; Non-Financial Interests, Personal, Writing Engagements: BMS, MSD; Non-Financial Interests, Personal, Principal Investigator: BMS, BioNTech SE, Sanofi, AstraZeneca; Non-Financial Interests, Personal, Stocks/Shares: BioNTech SE. A.M. Di Giacomo: Non-Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Bristol Myers Squibb, IncytePierre Fabre, Sanofi, GlaxoSmithKline , Novartis, SunPharma, Immunocore. J. Grewal: Financial Interests, Personal, Speaker’s Bureau: BMS, Ipsen, Eli Lilly; Non-Financial Interests, Personal, Advisory Board: Eisai. C.H.H. Ottensmeier: Non-Financial Interests, Institutional, Funding: BioNTech SE, MSD, Touchlight Genetics, Verastem; Non-Financial Interests, Personal, Invited Speaker: BMS; Non-Financial Interests, Personal, Advisory Role: Sebastian Bio, Neuvogen; Non-Financial Interests, Institutional, Principal Investigator: PsiOxus, Transgene. A. Atasoy: Financial Interests, Personal, Full or part-time Employment: BioNTech US Inc. S. Shpyro: Financial Interests, Personal, Full or part-time Employment: BioNTech SE. P. Brück: Financial Interests, Personal, Full or part-time Employment: BioNTech SE; Financial Interests, Personal, Stocks/Shares: BioNTech SE. J. Dias: Financial Interests, Personal, Full or part-time Employment: BioNTech SE. C. Ganser: Financial Interests, Personal, Full or part-time Employment: BioNTech SE; Financial Interests, Personal, Stocks/Shares: BioNTech SE. î Türeci: Financial Interests, Personal, Full or part-time Employment: BioNTech SE; Financial Interests, Personal, Stocks/Shares, Co-founder: BioNTech SE; Financial Interests, Personal and Institutional, Member of the Board of Directors: BioNTech SE; Financial Interests, Personal and Institutional, Ownership Interest, Co-founder: BioNTech SE, TRON; Financial Interests, Personal, Royalties, Holds patents: BioNTech SE, TRON; Financial Interests, Personal, Other: BioNTech SE; Financial Interests, Personal, Funding: TRON; Financial Interests, Personal, Leadership Role, CIMT President: TRON. U. Sahin: Financial Interests, Personal and Institutional, Member of the Board of Directors, CEO: BioNTech SE, TRON; Financial Interests, Personal and Institutional, Ownership Interest, Co-founder: BioNTech SE, TRON; Financial Interests, Personal, Stocks/Shares, Co-founder: BioNTech SE, TRON; Financial Interests, Personal, Royalties: BioNTech SE; Financial Interests, Personal, Other: BioNTech SE, TRON; Financial Interests, Personal, Funding: TRON; Financial Interests, Personal, Royalties, Holds patents: TRON.