In CheckMate 141, nivolumab monotherapy significantly prolonged overall survival (OS) vs IC (median [95% CI]: 7.5 [5.5, 9.1] mo vs 5.1 [4.0, 6.0] mo) and doubled response rate (13.3% vs 5.8%) in patients (pts) with R/M SCCHN. Here, we describe clinical outcomes by best overall response for the nivolumab and IC arms.
CheckMate 141 (NCT02105636) was a randomized, open-label, phase 3 trial in which pts (N = 361) with R/M SCCHN who progressed on or within 6 mo of platinum-based therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC of methotrexate, docetaxel, or cetuximab (n = 121). We analyzed the primary endpoint of OS and additional endpoint of safety by best overall response (complete or partial response [CR/PR], stable disease [SD], or progressive disease [PD]), assessed by investigators per RECIST 1.1 every 6 weeks beginning at week 9.
The minimum follow-up was 11.4 mo. Baseline demographics were similar across response groups and treatment arms. Median duration of therapy for nivolumab-treated pts with CR/PR, SD, and PD was 12.5 mo, 4.2 mo, and 1.6 mo, respectively. Estimates of median OS, 12-mo, and 18-mo survival rates favored nivolumab vs IC in the CR/PR and SD response groups (Table). The incidence of grade 3–4 treatment-related adverse events was lower for nivolumab vs IC within each of the response groups (CR/PR, SD, and PD).Table:
|(n = 32)||(n = 7)||(n = 55)||(n = 43)||(n = 100)||(n = 42)|
|Median OS, mo(95% CI)||NR||13.6||10.4||7.1||5.7||4.5|
|(NR, NR)||(8.9, NR)||(8.7, 15.2)||(5.4, 9.5)||(4.8, 7.8)||(3.6, 5.8)|
|HR (95% CI)||0.08 (0.01, 0.47)||0.53 (0.33, 0.85)||0.74 (0.51, 1.09)|
|12-mo OS rate, % (95% CI)||96.8||57.1||46.1||29.4||21.4||11.9|
|(79.2, 99.5)||(17.2, 83.7)||(32.4, 58.7)||(16.4, 43.7)||(13.9, 30.1)||(4.4, 23.6)|
|18-mo OS rate, % (95% CI)||86.1||38.1||32.6||11.7||3.0||4.8|
|(67.0, 94.6)||(6.1, 71.6)||(20.0, 45.8)||(3.6, 25.0)||(0.6, 8.9)||(0.5, 17.2)|
NR = not reached
Pts with CR/PR and SD had improved median OS and survival rates with nivolumab relative to single-agent standard therapy. Nivolumab’s safety profile was favorable vs IC, including for pts with CR/PR whose median duration of therapy was greater than a year.
Clinical trial identification
Legal entity responsible for the study
L. Licitra: Reports consultant/advisory support from Eisai, Bristol-Myers Squibb, MSD, Merck-Serono, Boehringer-Ingelheim, Novartis, AstraZeneca, Bayer Roche and honoraria/consultation fees from Eisai, Bristol-Myers Squibb, MSD, Merck Serono, Debiopharm, Sobi, AstraZeneca. R.L. Ferris: Reports other from Amgen, other from AstraZeneca/MedImmune, other from Bristol-Myers Squibb, other from EMD Serono, other from Lilly, other from Merck, other from Pfizer, other from VentiRx Pharmaceuticals, during the conduct of the study. G. Blumenschein Jr: Reports grants from Merck, AstraZeneca, Celgene, AbbVie, Genentech, Xcovery, Novartis, Bayer, Bristol-Myers Squibb, GSK, during the conduct of the study; other from Bristol-Myers Squibb, Bayer, Celgene, Clovis, AbbVie, Ariad, AstraZeneca, Merck, outside the submitted work. K.J. Harrington: Reports honoraria and advisory board roles from AstraZeneca, Bristol-Myers Squibb, Merck, MSD, Pfizer and research grants from MSD J. Guigay: Grants to institution: Bristol-Myers Squibb, Boehringer-Ingelheim, GlaxoSmithKline, Merck Serono. S. Kasper: Reports personal fees from Bristol-Myers Squibb, outside the submitted work. N.F. Saba: Reports personal fees from Bristol-Myers Squibb, personal fees from Pfizer, personal fees from Merck, personal fees from Lilly, outside the submitted work. R. Haddad: Reports grants from Bristol-Myers Squibb, Merck, Celgene, Pfizer, AstraZeneca, personal fees from Bristol-Myers Squibb, Merck, AstraZeneca, Pfizer, Celgene, Eisai, during the conduct of the study. N. Kiyota: Reports research grants from ONO Pharma, during the conduct of the study; research grants from Nippon Boehringer Ingelheim, AstraZeneca, Eisai, outside the submitted work; honoraria from ONO PHARMA, Bristol-Myers Squibb, Merck Serono, Eisai and Bayer. M. Monga: Reports other from Bristol-Myers Squibb, during the conduct of the study. M. Lynch: Dr Lynch in an employee of Bristol-Myers Squibb. L. Li: Employee of Bristol-Myers Squibb. M.L. Gillison: Reports personal fees from Celgene, Lilly, Amgen, GlaxoSmithKline; grants and personal fees from Bristol-Myers Squibb, Merck, AstraZeneca, grants from Kyowa, during the conduct of the study. J. Fayette: Reports personal fees from Bristol-Myers Squibb and AstraZeneca, outside the submitted work.