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ASCO 2022: 3-Year Trial Update on Nivolumab Plus Ipilimumab and Chemotherapy for Metastatic NSCLC

By: Julia Fiederlein
Posted: Thursday, June 9, 2022

According to Luis G. Paz-Ares, MD, PhD, of the Universidad Complutense de Madrid, and colleagues, in the phase III CheckMate 9LA trial, patients with metastatic non–small cell lung cancer (NSCLC) who underwent first-line treatment with nivolumab plus ipilimumab and chemotherapy seemed to derive a survival benefit compared with those who received chemotherapy alone. Data from the updated efficacy analysis were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA9026).

“With a 3-year minimum follow-up, first-line nivolumab plus ipilimumab and chemotherapy demonstrated a long-term, durable efficacy benefit versus chemotherapy,” the investigators commented. “Survival benefit…was observed regardless of KRAS and STK11 mutation status.”

Adults with stage IV or recurrent disease were randomly assigned in a 1:1 ratio to receive nivolumab plus ipilimumab and two cycles of chemotherapy (n = 361) or four cycles of chemotherapy alone (n = 358). They were stratified by tumor PD-L1 expression, sex, and histology. 

According to the investigators, patients continued to derive a long-term, durable overall survival benefit with nivolumab plus ipilimumab and chemotherapy versus chemotherapy alone at a minimum follow-up of 36.1 months (hazard ratio = 0.74); the 3-year overall survival rates were 27% and 19%, respectively. Clinical benefit with nivolumab plus ipilimumab and chemotherapy was observed in all randomly assigned patients and across most subgroups. Specifically, those with PD-L1 expression less than 1% had an overall survival rate of 25% with the dual immunotherapy–based combination versus 15% with chemotherapy alone. Among those with squamous histology, the overall survival rate was 24% with the investigational regimen versus 11% with chemotherapy alone.

In the 313 mutation-evaluable patients, the median duration of overall survival was prolonged with nivolumab plus ipilimumab and chemotherapy compared with chemotherapy alone (16.3 vs. 13.1 months); similar trends were observed in those with and without KRAS (mutated: 19.2 vs. 13.5 months; wild-type: 15.6 vs. 12.7 months) and STK11 (mutated: 13.8 vs. 10.7 months; wild-type: 17.8 vs. 13.9 months) mutations. No new safety signals were observed.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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