Randomized phase II clinical trial of cisplatin/carboplatin and etoposide (CE) alone or in combination with nivolumab as frontline therapy for extensive-stage small cell lung cancer (ES-SCLC): ECOG-ACRIN EA5161
Abstract No : 9000
Abstract Type : Oral Abstract Session
Indication : Small Cell Lung Cancer
Intervention : Nivolumab plus platinum-etoposide (CE)
Company : ECOGACRIN
Technology : Monoclonal antibody
This study was activated in May 2018 and completed accrual in December 2018. 160 patients were enrolled. Baseline characteristics were well balanced between arms. In the ITT population (n = 160), nivolumab+CE significantly improved the PFS compared to CE with HR0.65(95%CI,0.46,0.91;p= 0.012); mPFS5.5 versus 4.6 months,respectively. Secondary end point of OS was also improved with nivolumab + CE versus CE with HR 0.67 (95% CI, 0.46, 0.98; p = 0.038); mOS 11.3 versus 8.5 months. Among patients who initiated study therapy, nivolumab + CE significantly improved the PFS compared to CE with HR 0.68 (95% CI, 0.48, 1.00; p = 0.047); mPFS 5.5 versus 4.7 months, respectively; in this population, OS was also improved with nivolumab + CE versus CE with HR 0.73 (95%CI,0.49,1.11;p=0.14);mOS 11.3 versus 9.3months. The ORR was 52.29% versus 47.71%. The incidence of treatment-related grade 3/4 AEs was 77% versus 62% and AEs leading to discontinuation 6.21% versus 2.07%.Ten patients remain on maintenance nivolumab. Lethal adverse events independent of treatment were similar between the two arms(9 in arm A;7 in arm B).
The addition of nivolumab to CE as 1L treatment for ES-SCLC significantly improved PFS and OS. No new safety signals were observed.
Findings support the potential usage of nivolumab along with CE as 1L treatment for ES-SCLC.