Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer
Por:
Hellmann, MD, Paz-Ares, L, Caro, RB, Zurawski, B, Kim, SW, Costa, EC, Park, K, Alexandru, A, Lupinacci, L, Jimenez, ED, Sakai, H, Albert, I, Vergnenegre, A, Peters, S, Syrigos, K, Barlesi, F, Reck, M, Borghaei, H, Brahmer, JR, O'Byrne, KJ, Geese, WJ, Bhagavatheeswaran, P, Rabindran, SK, Kasinathan, RS, Nathan, FE and Ramalingam, SS
Publicada:
21 nov 2019
Ahead of Print:
28 sep 2019
Categoría:
Medicine (miscellaneous)
Resumen:
BACKGROUND
In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC.
METHODS
In this open-label, phase 3 trial, we randomly assigned patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. The patients who had a PD-L1 expression level of less than 1% were randomly assigned in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone. All the patients had received no previous chemotherapy. The primary end point reported here was overall survival with nivolumab plus ipilimumab as compared with chemotherapy in patients with a PD-L1 expression level of 1% or more.
RESULTS
Among the patients with a PD-L1 expression level of 1% or more, the median duration of overall survival was 17.1 months (95% confidence interval [CI], 15.0 to 20.1) with nivolumab plus ipilimumab and 14.9 months (95% CI, 12.7 to 16.7) with chemotherapy (P=0.007), with 2-year overall survival rates of 40.0% and 32.8%, respectively. The median duration of response was 23.2 months with nivolumab plus ipilimumab and 6.2 months with chemotherapy. The overall survival benefit was also observed in patients with a PD-L1 expression level of less than 1%, with a median duration of 17.2 months (95% CI, 12.8 to 22.0) with nivolumab plus ipilimumab and 12.2 months (95% CI, 9.2 to 14.3) with chemotherapy. Among all the patients in the trial, the median duration of overall survival was 17.1 months (95% CI, 15.2 to 19.9) with nivolumab plus ipilimumab and 13.9 months (95% CI, 12.2 to 15.1) with chemotherapy. The percentage of patients with grade 3 or 4 treatment-related adverse events in the overall population was 32.8% with nivolumab plus ipilimumab and 36.0% with chemotherapy.
CONCLUSIONS
First-line treatment with nivolumab plus ipilimumab resulted in a longer duration of overall survival than did chemotherapy in patients with NSCLC, independent of the PD-L1 expression level. No new safety concerns emerged with longer follow-up.
Filiaciones:
Hellmann, MD:
Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
Paz-Ares, L:
Univ Complutense, Ctr Nacl Invest Oncol, Hosp Univ Doce Octubre, Madrid, Spain
Ctr Invest Biomed Red Canc, Madrid, Spain
Caro, RB:
Hosp Univ Virgen del Rocio, Seville, Spain
Zurawski, B:
Ambulatorium Chemioterapii, Bydgoszcz, Poland
Kim, SW:
Asan Med Ctr, Seoul, South Korea
:
Germans Trias & Pujol Hosp, Catalan Inst Oncol, Badalona, Spain
Park, K:
Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Seoul, South Korea
Alexandru, A:
Inst Oncol Prof Dr Alexandru Trestioreanu, Bucharest, Romania
Lupinacci, L:
Hosp Italiano Buenos Aires, Buenos Aires, DF, Argentina
Jimenez, ED:
Inst Jalisciense Cancerol, Guadalajara, Jalisco, Mexico
Sakai, H:
Saitama Canc Ctr, Saitama, Japan
Albert, I:
Matrai Gyogyint, Matrahaza, Hungary
Vergnenegre, A:
Limoges Univ Hosp, Limoges, France
Peters, S:
Lausanne Univ, CHU Vaudois, Lausanne, Switzerland
Syrigos, K:
Univ Athens, Sotiria Gen Hosp, Athens, Greece
Barlesi, F:
Aix Marseille Univ, AP HM, INSERM, Natl Ctr Sci Res,Ctr Rech Cancerol Marseillen, Marseille, France
Reck, M:
German Ctr Lung Res, Airway Res Ctr North, Lung Clin Grosshansdorf, Grosshansdorf, Germany
Borghaei, H:
Fox Chase Canc Ctr, 7701 Burholme Ave, Philadelphia, PA 19111 USA
Brahmer, JR:
Johns Hopkins Kimmel Canc Ctr, Baltimore, MD USA
O'Byrne, KJ:
Princess Alexandra Hosp, Brisbane, Qld, Australia
Geese, WJ:
Bristol Myers Squibb, Princeton, NJ USA
Bhagavatheeswaran, P:
Bristol Myers Squibb, Princeton, NJ USA
Rabindran, SK:
Bristol Myers Squibb, Princeton, NJ USA
Kasinathan, RS:
Bristol Myers Squibb, Princeton, NJ USA
Nathan, FE:
Bristol Myers Squibb, Princeton, NJ USA
Ramalingam, SS:
Emory Univ, Winship Canc Inst, Atlanta, GA 30322 USA
Bronze
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