2936 - nab-Paclitaxel + Carboplatin Induction Followed by nab-Paclitaxel Maintenance in Squamous Non-Small Cell Lung Cancer (NSCLC): Results From the ABOUND.sqm Study

Background

Demonstrated benefit with maintenance therapy in patients (pts) with squamous NSCLC remains an unmet need. In a subset of pts with advanced squamous NSCLC from a large phase 3 trial, nab-P/C demonstrated a significantly higher improvement in the primary endpoint, overall response rate (ORR; 41% vs 24%; P < 0.001), vs P/C. The ABOUND.sqm study investigated induction nab-P/C followed by nab-P maintenance for these pts.

Methods

Pts with treatment-naive, advanced squamous NSCLC received 4 cycles of induction nab-P 100 mg/m² on d 1, 8, and 15 + C AUC 6 on d 1 (21-d cycles). Pts not progressing after 4 cycles were randomized 2:1 to maintenance nab-P 100 mg/m² on d 1 and 8 of each 21-d cycle + best supportive care (BSC) or BSC alone until disease progression (PD) or unacceptable toxicity. Progression-free survival (PFS) from randomization into the maintenance part of the study was the primary endpoint. Secondary endpoints included safety, overall survival (OS), and ORR.

Results

Of the 420 pts treated in the induction phase, 202 were randomized to maintenance nab-P + BSC (n = 136) or BSC alone (n = 66). In both arms, the median age was 68.0 yrs. All patients were followed for a minimum of 12 mos; median follow-up time for survival was 24.2 mos. PFS from randomization was not significantly different between nab-P + BSC and BSC alone (median, 3.1 vs 2.6 mos; P = 0.357); median OS was 17.6 and 12.2 mos, respectively. Additional efficacy outcomes are reported in the table. The most frequent grade 3/4 TEAEs over the entire study were neutropenia (53.1% vs 50.0%) and anemia (33.1% vs 32.3%).

Conclusions

Conclusions: Induction nab-P/C followed by maintenance nab-P is feasible for pts with advanced squamous NSCLC. PFS from randomization with nab-P + BSC was not significantly longer vs BSC alone; however, OS was encouraging. No new safety concerns were identified during nab-P maintenance.

Table. Efficacy outcomes

Clinical trial identification

NCT02027428

Editorial Acknowledgement