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
Results:
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).
Conclusion:
The addition of nivolumab to CE as 1L treatment for ES-SCLC significantly improved PFS and OS. No new safety signals were observed.
Commentary:
Findings support the potential usage of nivolumab along with CE as 1L treatment for ES-SCLC.
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