Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN
David R. Spigel , Karen L. Reckamp , Naiyer A. Rizvi , Elena Poddubskaya , Howard Jack West , Wilfried Ernst Erich Eberhardt , Paul Baas , Scott Joseph Antonia , Adam Pluzanski , Everett E. Vokes , Esther Holgado , David Michael Waterhouse , Neal Ready , Justin F. Gainor , Osvaldo Rudy Aren , Leora Horn , Luis Paz-Ares , Christine Baudelet , Brian Joseph Lestini , Julie R. Brahmer
Background: Treatment options are limited for patients (pts) with advanced SQ NSCLC who fail platinum-based doublet chemotherapy (PT-DC). We report results of a randomized, open-label, global phase III study of NIVO, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, vs DOC in pts with SQ NSCLC and with disease progression (PD) during/after one prior PT-DC regimen. Methods: Pts (N = 272) were randomized 1:1 to receive NIVO 3 mg/kg (n = 135) Q2W or DOC 75 mg/m2(n = 137) Q3W until PD, discontinuation due to toxicity, or other reasons. The primary objective was overall survival (OS). Secondary objectives included investigator-assessed objective response rate (ORR; RECIST v1.1), progression-free survival (PFS), efficacy by PD-L1 expression (PD-L1 testing not required for enrollment), quality of life, and safety. Results: Superior OS was observed with NIVO vs DOC (HR = 0.59; 95% CI: 0.44, 0.79; p = 0.00025). NIVO improved PFS vs DOC (HR = 0.62; 95% CI: 0.47, 0.81; p = 0.0004). ORR was 20% (27/135) for NIVO and 9% (12/137) for DOC (p = 0.0083). OS HRs favored NIVO regardless of PD-L1 expression (Table). Grade 3–4 drug-related AEs occurred in 7% (9/131) of NIVO and 55% (71/129) of DOC pts. No deaths were related to NIVO vs 3 DOC-related deaths. Conclusions: CheckMate 017 met its primary objective, demonstrating superior OS of NIVO vs DOC in pts with advanced, previously treated SQ NSCLC and demonstrated PFS and ORR superiority. Tumor PD-L1 status was neither prognostic nor predictive for efficacy endpoints. The safety profile of NIVO 3 mg/kg Q2W is acceptable and favorable vs DOC. NIVO represents a significant improvement in second-line therapy for SQ NSCLC. Clinical trial information: NCT01642004
NIVO (n = 135) | DOC (n = 137) | ||
---|---|---|---|
mOS, mo (95% CI) | 9.2 (7.3, 13.3) | 6.0 (5.1, 7.3) | |
1-yr OS, % (95% CI) | 42 (34, 50) | 24 (17, 31) | |
Median duration of response, mo (range) | Not Reached (2.9–20.5+) | 8.4 (1.4+–15.2+) | |
mPFS, mo (95% CI) | 3.5 (2.1, 4.9) | 2.8 (2.1, 3.5) | |
1-yr PFS, % (95% CI) | 21 (14, 28) | 6 (3, 12) | |
PD-1 expression | NIVO (n) | DOC (n) | OS HR (95% CI) |
≥ 1% | 63 | 56 | 0.69 (0.45, 1.05) |
< 1% | 54 | 52 | 0.58 (0.37, 0.92) |
≥ 5% | 42 | 39 | 0.53 (0.31, 0.89) |
< 5% | 75 | 69 | 0.70 (0.47, 1.02) |
≥ 10% | 36 | 33 | 0.50 (0.28, 0.89) |
< 10% | 81 | 75 | 0.70 (0.48, 1.01) |
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