|The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
The combination of nivolumab plus ipilimumab combined with a limited course of chemotherapy prolonged overall survival (OS) compared with chemotherapy alone among patients with stage IV non-small cell lung cancer (NSCLC), according to results from a preplanned interim analysis of the phase 3 CheckMate 9LA trial presented at the ASCO20 Virtual Scientific Program.
“We hypothesized that ending 2 cycles of chemotherapy could provide a rapid disease control while building on the long-term survival benefit by the combination of the nivolumab and ipilimumab,” said Martin Reck, MD, PhD, of the LungenClinic in Germany, and lead author and presenter of the study.
The phase 3 CheckMate 9LA trial (ClinicalTrials.gov Identifier: NCT03215706) randomly assigned 719 patients with previously untreated stage IV/recurrent NSCLC to receive nivolumab plus ipilimumab and 2 cycles of chemotherapy or 4 cycles of chemotherapy alone. Type of chemotherapy was selected according to histology, and pemetrexed maintenance was allowed for patients with nonsquamous histology in the chemotherapy-only arm. The primary endpoint was OS and the secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and efficacy by PD-L1 expression.
At baseline, the median age was 65, 30% of patients were female and 86.5% of patients were current or former smokers. Nonsquamous histology was present in 69% of patients, and PD-L1 positivity was present in 60.5%.
During a minimum follow-up of 12.7 months, nivolumab and ipilimumab with chemotherapy resulted in prolonged OS at a median of 15.6 months compared with 10.9 months in patients receiving chemotherapy alone (hazard ratio [HR], 0.66; 95% CI, 0.55-0.80). The 1-year OS was 63% in the combination group compared with 47% in the chemotherapy-only group.
The OS benefit with the combination was regardless of PD-L1 positivity and histology.
The combination was also favored across other multiple subgroups; however Dr Reck noted that “there was a reduced efficacy in the small groups of patients older than 75 years and never smoking patients on the other side.”
Median PFS was also improved in patients who received the nivolumab, ipilimumab, and chemotherapy combination at 6.7 months compared with 5.0 months with chemotherapy alone (HR, 0.68; 95% CI, 0.57-0.82). The 1-year PFS was 33% and 18% in the combination and chemotherapy arms, respectively.
The ORR was 38% with the combination compared with 25% with chemotherapy alone. The median duration of response was 11.3 months with nivolumab and ipilimumab plus chemotherapy compared with 5.6 months with chemotherapy alone.
Grade 3 to 4 treatment-related adverse events occurred in 47% of patients in the combination arm compared with 38% of patients in the chemotherapy-only arm. Any grade treatment-related adverse events that resulted in treatment discontinuation occurred in 19% and 7% of patients in the combination or chemotherapy alone arms, respectively.
“The CheckMate-9LA demonstrated that the combination of nivolumab and ipilimumab, together with a limited course of chemotherapy, should be considered as a new first line treatment opportunity for patients with advanced non-small cell lung cancer,” Dr Reck concluded.
Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2020 meeting by visiting the conference page.
Reck M, Ciuleanu T-E, Dols MC, et al. Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles chemo as first-line (1L) treatment (tx) for stage IV/recurrent non-small cell lung cancer (NSCLC): CheckMate 9LA. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 9501.