1503TiP - A phase II study of cemiplimab plus BNT116 versus cemiplimab alone in first-line treatment of patients with advanced non-small cell lung cancer with PD-L1 expression ≥50%

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.