Abstract 1048P
Background
Immunotherapy as single agent or in combinationis the standard of care for metastatic non-small-cell lung cancer (NSCLC), including LSCC. The SQUINT trial was a randomized, prospective, phase II trial which assesses the efficacy of nivolumab plus investigator-choice platinum-based chemotherapy (N-CT) versus the combination of nivolumab and ipilimumab (NI) in patients with advanced/metastatic LSCC.
Methods
All eligible patients were randomly assigned to either NI or N-CT. Nivolumab was administered at the standard dose of 360 mg every 3 weeks, while ipilimumab was administered at the dose of 1 mg/kg every 6 weeks. The primary endpoint was overall survival (OS) at 12 months. Availability of an adequate tumor sample obtained before trial inclusion was mandatory. All samples were analyzed using the Vela Diagnostics’ OncoKey SL 525 Plus Panelthat is a next-generation sequencing (NGS) assay that enables comprehensive genomic profiling of tumor samples. The panel contains 525 cancer-related genes that can be used to assess pathogenic single-nucleotide variants (SNV) and multiple-nucleotide variants, gene fusions, splice variants, copy number variants (CNVs), MSI, TMB, and ten oncogenic pathogens with both DNA and RNA simultaneously from FFPE samples.
Results
From September 2017 to February 2022, a total of 91 patients were included in the study; 45 were assigned to NI and 46 to N-CT. With a median follow-up of 18 months, 1-year OS rate was 59.4% with NI and 56.7% with N-CT. Median OS and median PFS were 14.7 and 3.8 months in the NI arm and 12.9 and 6.3 months in the N-CT arm. Response rate was 24.4% with NI and 34.8% with N-CT. In the NI arm median was 13.9, not reached and 16.3 months in PD-L1 negative, PD-L1 low and PD-L1 high, respectively. In the N-CT arm median OS was 12.1, 13.8 and 11.7 months in PD-L1 negative, PD-L1 low and PD-L1 high, respectively. Biomarker analyses are ongoing and results are not available at the time of this analysis.
Conclusions
Results of the SQUINT trial showed no difference between NI and N-CT for any clinical end-point. Correlative biomarker analyses will be presented at the meeting.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Fondazione Ricerca Traslazionale FoRT.
Funding
Bristol Myers Squibb.
Disclosure
F. Cappuzzo: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, PharmaMar, Mirati, Novocure, OSE, and MSD; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, Mirati, PharmaMar, Novocure, OSE, Galecto and MSD. S. Pilotto: Financial Interests, Personal, Invited Speaker: Bristol myers squibb, AstraZeneca, Merck & Co., Roche, Amgen, Novartis; Financial Interests, Personal, Advisory Board: Merck & Co., Amgen, AstraZeneca, Novartis; Financial Interests, Personal, Expert Testimony: Takeda; Financial Interests, Research Grant: Bristol Myers Squibb, AstraZeneca; Non-Financial Interests, Principal Investigator: AstraZeneca, Roche. L. Bonanno: Financial Interests, Institutional, Advisory Board: Astra-Zeneca, MSD, BMS, Roche; Financial Interests, Institutional, Invited Speaker: Astra-Zeneca, MSD, BMS, Roche, Boehringer Ing, Astra-Zeneca; Non-Financial Interests, Principal Investigator: Roche, AstraZeneca, Boehringer Ing, MSD, BMS, Janssen, PharmaMar. All other authors have declared no conflicts of interest.