Abstract 1503TiP
Background
Cemiplimab is an anti–programmed cell death-1 (PD-1) antibody approved as first-line monotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-ligand 1 (PD-L1) tumour cell expression. A high unmet medical need remains for patients with no or limited response to anti–PD-1/PD-L1 therapy. As prognosis is poor for these patients, there is growing interest in combining anti–PD-1 compounds with therapeutic cancer vaccines. BNT116 is an investigational mRNA-based therapeutic cancer vaccine consisting of a fixed set of 6 liposomally formulated RNAs, each encoding a different tumour-associated antigen frequently expressed in NSCLC.
Trial design
This is a randomised, multicentre, open-label phase 2 study of cemiplimab plus BNT116 versus cemiplimab alone in treatment-naive patients with stage IIIB, IIIC, or IV squamous or non-squamous NSCLC, who are ineligible for surgical resection or definitive chemoradiation. Patients must have PD-L1 expression on ≥50% of tumour cells (determined by analysis of resected tumour samples) and no actionable EGFR, ALK, or ROS1 aberrations. Patients in arm A will receive cemiplimab beginning Cycle 1 Day 1 (C1D1). Patients in arm B will receive cemiplimab beginning C1D1 and BNT116. The primary endpoint is objective response rate per blinded independent review committee of cemiplimab plus BNT116 versus cemiplimab alone. Secondary endpoints will assess other antitumour activities of cemiplimab plus BNT116 versus cemiplimab alone, as measured by objective response rate per investigator assessment, duration of response, progression-free survival, and overall survival, as well as safety and tolerability. Enrollment of up to 100 patients is planned. Enrolment is ongoing.
Clinical trial identification
NCT05557591.
Editorial acknowledgement
Medical writing support was provided by Talya Underwood of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc.
Legal entity responsible for the study
Regeneron Pharmaceuticals, Inc.
Funding
Regeneron Pharmaceuticals, Inc., and BioNTech SE.
Disclosure
M.M. Awad: Financial Interests, Personal, Advisory Role: Merck, Bristol Myers Squibb, Genentech, AstraZeneca, Nektar, Maverick, Blueprint Medicines, Syndax, AbbVie, Gritstone, ArcherDX, Mirati, NextCure, EMD Serono; Financial Interests, Personal, Research Funding: Bristol Myers Squibb, Lilly, Genentech, AstraZeneca. Y. Hao, S. Li, M. Kaul, F. Seebach, P. Goncalves, P. Rietschel: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks/Shares: Regeneron Pharmaceuticals, Inc. P. Brück: Financial Interests, Personal, Full or part-time Employment: BioNTech SE; Financial Interests, Personal, Stocks/Shares: BioNTech SE.
Resources from the same session
1564P - Gut microbiome and metabolome are associated with the response to chemoradiotherapy in patients with esophageal cancer
Presenter: Mingqiang Lin
Session: Poster session 21
1565P - ERCC1 gene polymorphism influences overall survival in early oesophageal cancer: Results from the phase III MRC OEO2 randomised controlled trial
Presenter: Georgina Keogh
Session: Poster session 21
1566P - Clinical relevance of circulating tumor DNA in HER2 -positive advanced gastric cancer: Results from phase Ib trial of HER2 and PD-1 dual targeted therapy (Ni-High)
Presenter: Hiroki Osumi
Session: Poster session 21
1567P - The effect of SGLT2i and DPP4i on new-onset gastric cancer and gastric diseases in type 2 diabetes mellitus: A population-based cohort study
Presenter: Hou In Chou
Session: Poster session 21
1568P - Establishment of a platform to predict radiation sensitivity in organoids derived from esophageal cancer patients
Presenter: Ga Yeon Kim
Session: Poster session 21