Makoto Nishio1, Fabrice Barlesi2, Howard West3, Simon Ball4, Rodolfo Bordoni5, Manuel Cobo6, Pascale Dubray Longeras7, Jerome Goldschmidt8, Silvia Novello9, Francisco Orlandi10, Rachel E Sanborn11, Zsuzsanna Szalai12, Grigoriy Ursol13, Diana Mendus14, Lijia Wang14, Xiaohui Wen14, Mark McCleland14, Tien Hoang14, See Phan14, Mark A Socinski15. 1. The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address: mnishio@jfcr.or.jp. 2. Department of Medical Oncology, Cancer Research Center of Marseille, Institut National de la Santé et de la Recherche Médicale, Centre National de la Recherche Scientifique, Assistance Publique-Hopitaux de Marseille, Campus Timone, Centres Hospitaliers et Universitaires Nord, Aix Marseille University, Marseille, France; Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France. 3. Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, California. 4. Department of Oncology, Queen's Hospital, Rom Valley Way, Romford, United Kingdom. 5. Northside Hospital Cancer Institute, Atlanta, Georgia. 6. Unidad de Gestión Clínica Intercentros de Oncología Médica. Hospitales Universitarios Regional y Virgen de la Victoria, Málaga, Spain. 7. Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France. 8. Blue Ridge Cancer Care, Blacksburg, Virginia. 9. Department of Oncology, University of Turin, Orbassano, Italy. 10. Department of Medical Oncology, Instituto Nacional del Tόrax, Santiago, Chile. 11. Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. 12. Department of Pulmonology, Petz Aladár County Teaching Hospital, Vasvári Pál, Hungary. 13. Acinus, Karla Marksa Kirovograd, Ukraine. 14. Genentech, Inc., South San Francisco, California. 15. Department of Medical Oncology, AdventHealth Cancer Institute, Orlando, Florida.
Abstract
INTRODUCTION: We report the final results of the phase 3 IMpower132 study evaluating atezolizumab plus carboplatin or cisplatin plus pemetrexed (APP) in patients with nonsquamous NSCLC. METHODS:Chemotherapy-naive patients with stage IVnonsquamous NSCLC without sensitizing EGFR or ALK genetic alterations were randomized in a one-to-one ratio to receive four or six 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 end points 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 mo), APP exhibited significant PFS improvement versus PP (median = 7.6 versus 5.2 mo, stratified hazard ratio [HR] = 0.60, 95% confidence interval [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 versus 13.6 mo, stratified HR = 0.81, 95% CI: 0.64-1.03, p = 0.0797) and final analyses (July 18, 2019; median = 17.5 versus 13.6 mo; stratified HR = 0.86, 95% CI: 0.71-1.06, p = 0.1546). The OS and PFS results favored APP versus PP across subgroups. Grade 3 or 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 end point but not its co-primary OS end point, with numerical improvement for OS in the APP arm. APP had a manageable safety profile, with no new or unexpected safety signals identified.
RCT Entities:
INTRODUCTION: We report the final results of the phase 3 IMpower132 study evaluating atezolizumab pluscarboplatin or cisplatin plus pemetrexed (APP) in patients with nonsquamous NSCLC. METHODS: Chemotherapy-naive patients with stage IV nonsquamous NSCLC without sensitizing EGFR or ALK genetic alterations were randomized in a one-to-one ratio to receive four or six 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 end points 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 mo), APP exhibited significant PFS improvement versus PP (median = 7.6 versus 5.2 mo, stratified hazard ratio [HR] = 0.60, 95% confidence interval [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 versus 13.6 mo, stratified HR = 0.81, 95% CI: 0.64-1.03, p = 0.0797) and final analyses (July 18, 2019; median = 17.5 versus 13.6 mo; stratified HR = 0.86, 95% CI: 0.71-1.06, p = 0.1546). The OS and PFS results favored APP versus PP across subgroups. Grade 3 or 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 end point but not its co-primary OS end point, with numerical improvement for OS in the APP arm. APP had a manageable safety profile, with no new or unexpected safety signals identified.
Authors: Diego L Kaen; Nicolas Minatta; Alessandro Russo; Umberto Malapelle; Diego de Miguel-Pérez; Christian Rolfo Journal: Adv Exp Med Biol Date: 2021 Impact factor: 2.622
Authors: Yu Fujiwara; Nobuyuki Horita; Matthew Harrington; Ho Namkoong; Hirotaka Miyashita; Matthew D Galsky Journal: Cancer Immunol Immunother Date: 2022-04-26 Impact factor: 6.630