Abstract 208P
Background
In the randomized phase III CheckMate (CM) 816 study, neoadjuvant NIVO plus chemo demonstrated statistically significant and clinically meaningful improvements in Event-Free Survival (EFS) and pathological Complete Response (pCR) vs. chemo in patients (pts) with resectable NSCLC. To date, no study has assessed these outcomes in a rw setting.
Methods
This multi-center, non-interventional, retrospective chart review study was based on a cohort of 100 consecutive pts with resectable NSCLC treated in 7 different sites in France. Primary endpoint was pCR, as assessed by the local pathologist on resected tumor and lymph node tissue and calculated on the overall population.
Results
101 pts were enrolled, including 1/4/33/50/11 pts with stage Ib/IIa/IIb/IIIa/IIIb NSCLC (TNM 8). 92 patients had PD-L1 expression assessed as follows: 4/52/36 pts with expression
Conclusions
This is the first, multi-center rw-evidence study of neoadjuvant NIVO plus chemo, that demonstrates consistent pCR results as observed in the CM-816 trial, together with the absence of unforeseen AEs and of unexpected rates of surgery cancellation. Clinical trial identification: NCT06735781.
Legal entity responsible for the study
Bristol Myers Squibb/Curie Institute.
Funding
Bristol Myers Squibb.
Disclosure
N. Girard: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Regeneron, AbbVie, Amgen, Lilly, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen, Pierre Fabre, BeiGene; Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Pfizer, Amgen, MSD, Sanofi, Gilead, Janssen; Financial Interests, Personal, Officer: Edimark; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Other, Personal, Other, Family member is an employee: AstraZeneca. Q. Thomas: Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Other, Travel: Bristol Myers Squibb, Roche. B. Godbert: Non-Financial Interests, Personal, Other, Support for the abstract: Bristol Myers Squibb; Financial Interests, Personal, Other, Consulting fees: Bristol Myers Squibb, MSD, AstraZeneca, Johnson & Johnson, Sivan, Amgen, Roche, Pfizer; Financial Interests, Personal, Other, Travel: Pfizer; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, MSD, AstraZeneca, Johnson & Johnson, Sivan, Amgen, Roche, Pfizer. E. Grolleau: Financial Interests, Personal, Other, travel: Agir a dom, Asdia. P. Demontrond: Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Other, Travel: Health Accord, Takeda; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb. V. Avrillon: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Pfizer; Financial Interests, Personal, Other, Travel: Pfizer, Sanofi. O. Bylicki: Financial Interests, Personal, Other, Consulting fees: Bristol Myers Squibb, AstraZeneca, MSD, Takeda; Financial Interests, Personal, Other, Travel: MSD, AstraZeneca. F. Brellier, S. Lucherini, L. Vo, A. Prudent: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. O. Tifoun: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. H. Curcio: Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel: Sandoz, GSK, AstraZeneca; Financial Interests, Institutional, Advisory Board: Takeda, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim. X. Quantin: Financial Interests, Institutional, Advisory Board: Bristol Myers Squibb. F. Lucibello: Financial Interests, Personal, Other, Consulting fees: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel: Bristol Myers Squibb. All other authors have declared no conflicts of interest.