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ORAL 32 - EGFR WT and MT Targeting (ID 144)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:K.J. O'Byrne, D.R. Gandara
- Coordinates: 9/09/2015, 16:45 - 18:15, Four Seasons Ballroom F3+F4
ORAL32.03 - Efficacy and Safety of Necitumumab Continuation Therapy in Phase 3 SQUIRE Study (ID 1391)
16:45 - 18:15 | Author(s): T. Ciuleanu
The SQUIRE study demonstrated that the addition of necitumumab (N) to gemcitabine-cisplatin (GC) improved survival in patients with stage IV sq-NSCLC. This retrospective analysis compares efficacy and safety outcomes for patients who received single-agent N as continuation therapy after completion of chemotherapy treatment (CT) in GC+N arm to the continuation therapy-eligible population of the GC arm.
Patients 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), or GC alone every 21 days up to 6 cycles. Patients in GC+N with no progression continued on N alone until progressive disease. In this analysis, we consider patients in GC+N arm who were alive and progression-free before the start of N single-agent therapy (GC+N arm continuation therapy patients) and patients in GC arm who were alive, progression-free after completion of CT and did not discontinue treatment due to adverse event (AE) (GC arm non-progressor patients). This analysis included patients in both arms who received ≥4 cycles of CT. Overall survival (OS) and progression-free survival (PFS) were measured from the date of randomization, with parameters estimated using the Kaplan-Meier method. Hazard ratios and 95% CIs between subgroups were estimated from stratified Cox proportional hazards models. OS and PFS for post-induction period were measured from the completion of CT + 21 days. Selected treatment-emergent AEs (TEAEs) for patients in each arm are presented in the table.
261 patients were progression-free, received ≥4 cycles of CT, and received ≥1 dose of N alone in GC+N arm. 215 pts in GC arm completed ≥4 cycles of CT, were progression-free, and did not discontinue due to AE. Patient baseline characteristics and exposure to CT were well balanced between GC+N and GC arms. Median OS from randomization in GC+N vs GC was 15.9 vs 15.0 months; HR 0.85 (95% CI, 0.69, 1.05). Median OS for post-induction period in GC+N vs GC was 11.5 vs 10.9 months; HR 0.84 (95% CI, 0.68; 1.04). Median PFS from randomization in GC+N vs GC was 7.4 vs 6.9 months; HR 0.86 (95% CI, 0.70, 1.06). Median PFS from post-induction period in GC+N vs GC was 3.2 vs 2.3 months; HR 0.85 (95% CI, 0.70, 1.04). Selected TEAEs (Overall):
GC+N Continuation PatientsN = 261, % GC Non-ProgressorsN = 215, % Category Any Grade Grade ≥3 Any Grade Grade ≥3 Neutropenia 55.9 34.1 57.7 33.0 Anemia 46.7 10.0 49.3 8.8 Thrombocytopenia 26.1 9.6 29.3 12.6 Hypomagnesemia 42.1 14.9 18.6 0.9 Conjunctivitis 11.9 0.8 3.3 0 Rash 87.4 8.8 10.2 0.5 Arterial thromboembolic event 5.7 3.1 0.5 0 Venous thromboembolic event 9.2 3.8 4.2 0.9
There was a consistent treatment effect in favor of GC+N continuation patients as compared to GC non-progressors with no unexpected increases in AEs.
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