Study design: CheckMate 227 Part 1 (NSCLC)
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- Phase 3, open-label, randomized study in patients with recurrent/metastatic NSCLC1
- Independent co-primary endpoints (NIVO + IPI vs chemo): PFS in high TMB (≥10 mut/Mb) populationa,b; OS in PD-L1 ≥1% population1
- Secondary endpoints (PD-L1 hierarchy): PFS (NIVO + chemo vs chemo in PD-L1 <1%); OS (NIVO + chemo vs chemo in PD-L1 <1%); OS (NIVO vs chemo in PD-L1 ≥50%)1
*Nivolumab in combination with ipilimumab for NSCLC is not approved in Hong Kong; this information is from the FDA-approved indication. The FDA-approved is only for 1L NSCLC in which tumors express PD-L1 (>1%).
aTMB primary endpoint analysis conducted at January 24, 2018, database lock in subset of patients randomized to NIVO + IPI or chemo; alpha allocated was 0.025. bAlpha allocated was 0.025 overall (0.023 for final analysis).cNSQ: pemetrexed + cisplatin or carboplatin, Q3W for ≤4 cycles, with optional pemetrexed maintenance following chemo or NIVO + pemetrexed maintenance following NIVO + chemo; SQ: gemcitabine + cisplatin, or gemcitabine + carboplatin, Q3W for ≤4 cycles.
1L, first-line; ALK, anaplastic lymphoma kinase; chemo, chemotherapy; CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group Performance Status; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; IPI, ipilimumab; NIVO, nivolumab; NSCLC, non-small cell lung cancer; NSQ, non-squamous; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; QxW, every x weeks; R, randomization; SQ, squamous; TMB, tumor mutational burden.