2018 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Oral Abstract Session
Time: Monday June 4, 3:00 PM to 6:00 PM
Location: Hall B1
Nivolumab (Nivo) + platinum-doublet chemotherapy (Chemo) vs chemo as first-line (1L) treatment (Tx) for advanced non-small cell lung cancer (NSCLC) with <1% tumor PD-L1 expression: Results from CheckMate 227.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2018 ASCO Annual Meeting
J Clin Oncol 36, 2018 (suppl; abstr 9001)
Author(s): Hossein Borghaei, Matthew David Hellmann, Luis G. Paz-Ares, Suresh S. Ramalingam, Martin Reck, Kenneth John O'Byrne, Prabhu Bhagavatheeswaran, Faith Ellen Nathan, Julie R. Brahmer; Fox Chase Cancer Center, Philadelphia, PA; Memorial Sloan Kettering Cancer Center, New York, NY; Hospital Universitario Doce de Octubre, Madrid, Spain; Winship Cancer Institute, Emory University, Atlanta, GA; LungenClinic Grosshansdorf, German Center for Lung Research, Grosshansdorf, Germany; Princess Alexandra Hospital Brisbane, Queensland, Australia; Bristol-Myers Squibb, Princeton, NJ; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Background: CheckMate 227 (NCT02477826), a phase 3 study of 1L nivo + ipilimumab (ipi), nivo, or nivo + chemo vs chemo in advanced NSCLC, met its co-primary endpoint of prolonged progression-free survival (PFS) with nivo + ipi vs chemo in patients (pts) with tumor mutational burden ≥10 mutations/Mb. Identifying effective tx for pts without known predictive biomarkers remains an unmet need. Prior studies suggest addition of chemo to anti–PD-(L)1 tx can improve outcomes in an unselected pt population, although benefit is most pronounced in pts with higher tumor PD-L1 expression. We report results for nivo + chemo vs chemo in pts with < 1% tumor PD-L1 expression. Methods: Pts (n = 550) with chemo-naive, stage IV/recurrent NSCLC, no known sensitizing EGFR/ALK mutations, and < 1% tumor PD-L1 expression were stratified by tumor histology and randomized 1:1:1 to nivo 3 mg/kg Q2W + ipi 1 mg/kg Q6W, nivo 360 mg Q3W + chemo, or chemo (optional pemetrexed maintenance after chemo for nonsquamous [non-SQ] NSCLC). Pts were treated up to 2 yr. A descriptive analysis was performed for the secondary endpoint of PFS for nivo + chemo vs chemo in pts with < 1% tumor PD-L1 expression. No alpha was allocated for this analysis. Results: Baseline characteristics were balanced between nivo + chemo (n = 177) and chemo (n = 186) arms. PFS was improved with nivo + chemo vs chemo (HR = 0.74 [95% CI: 0.58, 0.94]; minimum follow-up 11.2 mo; descriptive comparison). PFS benefit with nivo + chemo was observed across most subgroups. Among histologic subgroups, benefit was more pronounced in non-SQ (HR = 0.68) relative to SQ NSCLC (HR = 0.92). Rates of any grade tx-related adverse events leading to discontinuation were 13% with nivo + chemo and 14% with chemo. Conclusions: 1L nivo + chemo improved PFS vs chemo in pts with advanced NSCLC and < 1% tumor PD-L1 expression, and was well tolerated. Results are encouraging in this analysis, which includes only pts with < 1% PD-L1. CheckMate 227 Part 2 (ongoing) is evaluating nivo + chemo vs chemo irrespective of PD-L1 expression and will further inform benefit from this combination across different subgroups of NSCLC. Clinical trial information: NCT02477826
1. Pembrolizumab (pembro) versus platinum-based chemotherapy (chemo) as first-line therapy for advanced/metastatic NSCLC with a PD-L1 tumor proportion score (TPS) ≥ 1%: Open-label, phase 3 KEYNOTE-042 study.