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A randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin (GC) chemotherapy plus necitumumab (IMC-11F8/LY3012211) versus GC alone in the first-line treatment of patients (pts) with stage IV squamous non-small cell lung cancer (sq-NSCLC).
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Background: Necitumumab (N), a human IgG1 anti-EGFR monoclonal antibody, inhibits ligand-binding and receptor activation. EGFR is detectable in the vast majority of advanced sq-NSCLC tumors. Methods: Pts with pathologically proven stage IV sq-NSCLC were randomized 1:1 to GC (G=1250 mg/m² iv, days 1 and 8; C=75 mg/m² iv, day 1) plus N (800 mg iv, days 1 and 8) (GC+N arm), or GC alone (GC arm) every 21 days for up to 6 cycles. GC+N pts with no progression continued on N alone until progressive disease or intolerable toxicity. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. EGFR protein expression level by immunohistochemistry (H-score) in tumor tissue was an exploratory analysis. Planned sample size was 1080 pts, with 90% power and a 2-sided alpha level of 0.05. Results: 1,093 pts were randomized (n=545, GC+N; n=548, GC). Baseline characteristics were balanced between GC+N and GC, respectively, including males (82.6% and 83.6%), ECOG PS 0/1 (91.0% and 91.2%), and PS 2 (9.0% and 8.6%). Exposure to chemotherapy was similar in both arms; median dose intensity (DI) for G and C was 86% and 95%, respectively, and DI for N was 94%. 51% of GC+N pts continued N alone for a median of 4 additional cycles. The addition of N to GC statistically significantly improved OS (HR=0.84, p=0.012) and PFS (HR=0.85, p=0.020); mOS was 11.5 vs 9.9 mo in GC and mPFS was 5.7 vs 5.5 mo in GC. ORR was 31% vs 29% in GC (p=0.400), and the disease control rate (DCR) was 82% vs 77% in GC (p=0.043). Post-progression anticancer therapy was similar (47% vs 45%). Several prespecified subgroup analyses of OS and PFS showed a consistent treatment effect, including pts with ECOG PS 2. Grade ≥3 adverse events with GC+N (measured by preferred MedDRA terms) that showed a >2% increase over GC were hypomagnesemia (8.7% vs 1.1%) and skin rash (3.7% vs 0.2%). Conclusions: The addition of N to GC statistically significantly improved OS, PFS, and DCR. The safety profile of GC+N is acceptable. Clinical trial information: NCT00981058.
Abstracts by Nick Thatcher:
- Meeting: 2013 ASCO Annual Meeting | Abstract No: 3053
START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer.Meeting: 2013 ASCO Annual Meeting | Abstract No: 7500