RT Journal Article
T1 Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.
A1 Owonikoko, Taofeek K
A1 Park, Keunchil
A1 Govindan, Ramaswamy
A1 Ready, Neal
A1 Reck, Martin
A1 Peters, Solange
A1 Dakhil, Shaker R
A1 Navarro, Alejandro
A1 Rodríguez-Cid, Jerónimo
A1 Schenker, Michael
A1 Lee, Jong-Seok
A1 Gutierrez, Vanesa
A1 Percent, Ivor
A1 Morgensztern, Daniel
A1 Barrios, Carlos H
A1 Greillier, Laurent
A1 Baka, Sofia
A1 Patel, Miten
A1 Lin, Wen Hong
A1 Selvaggi, Giovanni
A1 Baudelet, Christine
A1 Baden, Jonathan
A1 Pandya, Dimple
A1 Doshi, Parul
A1 Kim, Hye Ryun
AB In extensive-disease small-cell lung cancer (ED-SCLC), response rates to first-line platinum-based chemotherapy are robust, but responses lack durability. CheckMate 451, a double-blind phase III trial, evaluated nivolumab plus ipilimumab and nivolumab monotherapy as maintenance therapy following first-line chemotherapy for ED-SCLC. Patients with ED-SCLC, Eastern Cooperative Oncology Group performance status 0-1, and no progression after ≤ 4 cycles of first-line chemotherapy were randomly assigned (1:1:1) to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks for 12 weeks followed by nivolumab 240 mg once every 2 weeks, nivolumab 240 mg once every 2 weeks, or placebo for ≤ 2 years or until progression or unacceptable toxicity. Primary end point was overall survival (OS) with nivolumab plus ipilimumab versus placebo. Secondary end points were hierarchically tested. Overall, 834 patients were randomly assigned. The minimum follow-up was 8.9 months. OS was not significantly prolonged with nivolumab plus ipilimumab versus placebo (hazard ratio [HR], 0.92; 95% CI, 0.75 to 1.12; P = .37; median, 9.2 v 9.6 months). The HR for OS with nivolumab versus placebo was 0.84 (95% CI, 0.69 to 1.02); the median OS for nivolumab was 10.4 months. Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81). A trend toward OS benefit with nivolumab plus ipilimumab was observed in patients with tumor mutational burden ≥ 13 mutations per megabase. Rates of grade 3-4 treatment-related adverse events were nivolumab plus ipilimumab (52.2%), nivolumab (11.5%), and placebo (8.4%). Maintenance therapy with nivolumab plus ipilimumab did not prolong OS for patients with ED-SCLC who did not progress on first-line chemotherapy. There were no new safety signals.
YR 2021
FD 2021-03-08
LK http://hdl.handle.net/10668/17328
UL http://hdl.handle.net/10668/17328
LA en
DS RISalud
RD Apr 7, 2025