INTRODUCTION: We report final results from the Phase III IMpower132 study evaluating atezolizumab plus carboplatin or cisplatin and pemetrexed (APP) in patients with non-squamous non-small cell lung cancer (NSCLC).METHODS: Chemotherapy-naive patients with stage IV non-squamous NSCLC without sensitizing EGFR or ALK genetic alterations were randomized 1:1 to receive 4 or 6 cycles of carboplatin or cisplatin plus pemetrexed (PP) or APP every 3 weeks, followed by maintenance therapy with atezolizumab plus pemetrexed or pemetrexed alone. Co-primary endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS).RESULTS: The intention-to-treat population included 578 patients (APP, n=292; PP, n=286). At the primary PFS analysis (May 22, 2018; median follow-up, 14.8 months), APP demonstrated significant PFS improvement vs PP (median, 7.6 vs 5.2 months; stratified HR, 0.60 [95% CI: 0.49, 0.72]; P<0.0001). OS for the APP group was numerically better but not statistically significant at the interim (May 22, 2018; median 18.1 vs 13.6 months; stratified HR, 0.81 [95% CI: 0.64, 1.03]; P=0.0797) and final analyses (July 18, 2019; median 17.5 vs 13.6 months; stratified HR, 0.86 [95% CI: 0.71, 1.06]; P=0.1546). OS and PFS results favored APP versus PP across subgroups. Grade 3/4 treatment-related adverse events occurred in 54.6% (APP) and 40.1% (PP) of patients; Grade 5 treatment-related events occurred in 3.8% and 2.9%, respectively.CONCLUSIONS: IMpower132 met its co-primary PFS endpoint but not its co-primary OS endpoint, with numerical improvement for OS in the APP arm. APP had a manageable safety profile, with no new or unexpected safety signals identified.
Atezolizumab Plus Chemotherapy for First-Line Treatment of Non-Squamous Non-Small Cell Lung Cancer: Results From the Randomized Phase III IMpower132 Trial
Novello, Silvia;
2021-01-01
Abstract
INTRODUCTION: We report final results from the Phase III IMpower132 study evaluating atezolizumab plus carboplatin or cisplatin and pemetrexed (APP) in patients with non-squamous non-small cell lung cancer (NSCLC).METHODS: Chemotherapy-naive patients with stage IV non-squamous NSCLC without sensitizing EGFR or ALK genetic alterations were randomized 1:1 to receive 4 or 6 cycles of carboplatin or cisplatin plus pemetrexed (PP) or APP every 3 weeks, followed by maintenance therapy with atezolizumab plus pemetrexed or pemetrexed alone. Co-primary endpoints were overall survival (OS) and investigator-assessed progression-free survival (PFS).RESULTS: The intention-to-treat population included 578 patients (APP, n=292; PP, n=286). At the primary PFS analysis (May 22, 2018; median follow-up, 14.8 months), APP demonstrated significant PFS improvement vs PP (median, 7.6 vs 5.2 months; stratified HR, 0.60 [95% CI: 0.49, 0.72]; P<0.0001). OS for the APP group was numerically better but not statistically significant at the interim (May 22, 2018; median 18.1 vs 13.6 months; stratified HR, 0.81 [95% CI: 0.64, 1.03]; P=0.0797) and final analyses (July 18, 2019; median 17.5 vs 13.6 months; stratified HR, 0.86 [95% CI: 0.71, 1.06]; P=0.1546). OS and PFS results favored APP versus PP across subgroups. Grade 3/4 treatment-related adverse events occurred in 54.6% (APP) and 40.1% (PP) of patients; Grade 5 treatment-related events occurred in 3.8% and 2.9%, respectively.CONCLUSIONS: IMpower132 met its co-primary PFS endpoint but not its co-primary OS endpoint, with numerical improvement for OS in the APP arm. APP had a manageable safety profile, with no new or unexpected safety signals identified.
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