Mark A Socinski1, Makoto Nishio2, Robert M Jotte3, Federico Cappuzzo4, Francisco Orlandi5, Daniil Stroyakovskiy6, Naoyuki Nogami7, Delvys Rodríguez-Abreu8, Denis Moro-Sibilot9, Christian A Thomas10, Fabrice Barlesi11, Gene Finley12, Shengchun Kong13, Anthony Lee13, Shelley Coleman13, Wei Zou13, Mark McCleland13, Geetha Shankar13, Martin Reck14. 1. AdventHealth Cancer Institute, Orlando, Florida. 2. The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. 3. Rocky Mountain Cancer Centers, Denver, Colorado; US Oncology, Houston, Texas. 4. Istituto Nazionale Tumori "Regina Elena," Rome, Italy. 5. Instituto Nacional del Tórax, Prosalud Oncología, Santiago, Chile. 6. Moscow City Oncology Hospital No. 62, Moscow, Russia. 7. National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan. 8. Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain. 9. Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France. 10. New England Cancer Specialists, Scarborough, Maine. 11. Aix-Marseille Université, CNRS, INSERM, CRCM, Assistance Publique Hôpitaux de Marseille, Marseille, France. 12. Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania. 13. Genentech, Inc., South San Francisco, California. 14. LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany. Electronic address: mark.socinski.md@adventhealth.com.
Abstract
INTRODUCTION: We report final overall survival (OS) analyses of atezolizumab-carboplatin-paclitaxel (ACP [experimental arm]) and OS data with ≈ 39.8 months of median follow-up with atezolizumab-bevacizumab-carboplatin-paclitaxel (ABCP) versus bevacizumab-carboplatin-paclitaxel (BCP) in chemotherapy-naive patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) in the Phase III IMpower150 study (NCT02366143). METHODS: In this randomized, open-label study (N = 1202), coprimary endpoints included investigator-assessed progression-free survival and OS in intention-to-treat (ITT) wild-type (WT; no EGFR or ALK alterations) patients. Secondary and exploratory endpoints included OS in ITT and PD-L1 subgroups defined by the VENTANA SP142 and SP263 immunohistochemistry assays. RESULTS: At the final analysis with ACP vs BCP (data cutoff: September 13, 2019; minimum follow-up: 32.4 months), ACP showed numerical, but not statistically significant, improvements in OS (ITT-WT: median OS [mOS] 19.0 vs 14.7 months; hazard ratio [HR] 0.84; 95% CI, 0.71-1.00). OS benefit was sustained with ABCP vs BCP (ITT-WT: 19.5 vs 14.7 months; HR 0.80; 95% CI, 0.67-0.95). Exploratory analyses in the SP142-defined PD-L1 subgroups showed longer median OS with ABCP and ACP vs BCP in PD-L1-high and PD-L1-positive subgroups; in the PD-L1-negative subgroups, median OS was similar with ACP and ABCP vs BCP. Safety was consistent with that in earlier analyses (data cutoff: Jan 22, 2018). CONCLUSIONS: At the final IMpower150 OS analysis, ACP showed numerically, but not statistically significant, OS improvement vs BCP. Updated data with an additional 20 months of follow-up showed continued OS improvement with ABCP vs BCP in all patients.
RCT Entities:
INTRODUCTION: We report final overall survival (OS) analyses of atezolizumab-carboplatin-paclitaxel (ACP [experimental arm]) and OS data with ≈ 39.8 months of median follow-up with atezolizumab-bevacizumab-carboplatin-paclitaxel (ABCP) versus bevacizumab-carboplatin-paclitaxel (BCP) in chemotherapy-naive patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) in the Phase III IMpower150 study (NCT02366143). METHODS: In this randomized, open-label study (N = 1202), coprimary endpoints included investigator-assessed progression-free survival and OS in intention-to-treat (ITT) wild-type (WT; no EGFR or ALK alterations) patients. Secondary and exploratory endpoints included OS in ITT and PD-L1 subgroups defined by the VENTANA SP142 and SP263 immunohistochemistry assays. RESULTS: At the final analysis with ACP vs BCP (data cutoff: September 13, 2019; minimum follow-up: 32.4 months), ACP showed numerical, but not statistically significant, improvements in OS (ITT-WT: median OS [mOS] 19.0 vs 14.7 months; hazard ratio [HR] 0.84; 95% CI, 0.71-1.00). OS benefit was sustained with ABCP vs BCP (ITT-WT: 19.5 vs 14.7 months; HR 0.80; 95% CI, 0.67-0.95). Exploratory analyses in the SP142-defined PD-L1 subgroups showed longer median OS with ABCP and ACP vs BCP in PD-L1-high and PD-L1-positive subgroups; in the PD-L1-negative subgroups, median OS was similar with ACP and ABCP vs BCP. Safety was consistent with that in earlier analyses (data cutoff: Jan 22, 2018). CONCLUSIONS: At the final IMpower150 OS analysis, ACP showed numerically, but not statistically significant, OS improvement vs BCP. Updated data with an additional 20 months of follow-up showed continued OS improvement with ABCP vs BCP in all patients.