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CheckMate-9LA was designed as a phase 3 randomized study to evaluate NIVO + IPI plus 2 cycles of chemotherapy compared with chemotherapy alone in first-line patients with stage IV or recurrent NSCLC. Researchers hypothesized that a limited course of chemotherapy added to NIVO + IPI could provide rapid disease control and enhance the durable OS benefit seen with the PD-1 and CTLA-4 inhibitor combination. American Society of Clinical Oncology (ASCO), June 2021 Abstract 9000.The combination of nivolumab combined with ipilimumab (NIVO + IPI) has demonstrated improved overall survival (OS) and durability of response versus chemotherapy in treatment-naïve patients with advanced non–small-cell lung cancer (NSCLC) in CheckMate-227 Part 1, regardless of PD-L1 expression.
#Checkmate 9la update#
First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): two-year update from CheckMate 9LA. With 2 years of minimum follow-up, first-line NIVO/IPI + chemotherapy demonstrated durable survival and other efficacy benefits relative to chemotherapy in patients with advanced NSCLC, and no new safety signals were identified.
1Īll grade and grade 3/4 treatment-related adverse events were reported in 92% and 48% of patients in the NIVO + IPI + chemotherapy arm, compared with 88% and 38% in the chemotherapy-alone arm. 1 ORR was 38% with NIVO/IPI + chemotherapy with a median DOR of 13.0 months compared with 25% ORR with chemotherapy and a median DOR of 5.6 months with similar clinical benefit observed in all randomized patients and across the majority of subgroups, including by PD-L1 expression level and histology. 1 NIVO/IPI + chemotherapy resulted in a median PFS of 6.7 months versus 5.3 months for chemotherapy alone (HR, 0.67 95% CI, 0.56-0.79) with 8% and 37% of patients who had disease progression receiving subsequent immunotherapy, respectively. 1 The median OS for NIVO/IPI + chemotherapy was 15.8 months versus 11.0 months for chemotherapy alone (hazard ratio, 0.72 95% confidence interval, 0.61-0.86), and 2-year OS rates were 38% versus 26%, respectively. 1Īfter a follow-up of ≥24.4 months, patients treated with NIVO/IPI + chemotherapy derived an increase in OS compared with chemotherapy alone. The primary end point was OS, secondary end points included PFS and ORR by blinded independent central review, and efficacy by different PD-L1 levels with safety as an exploratory end point. Patients with nonsquamous NSCLC in the chemotherapy-alone arm could receive pemetrexed maintenance. Patients were randomized 1:1 to NIVO 360 mg every 3 weeks plus IPI 1 mg/kg every 6 weeks + 2 cycles of chemotherapy (n = 361) or 4 cycles of chemotherapy (n = 358). 1Īdult patients with stage IV recurrent NSCLC, Eastern Cooperative Oncology Group performance status of 0 or 1, and no known sensitizing EGFR or ALK alterations were stratified by PD-L1 score (<1% vs ≥1%), sex, and histology (squamous vs nonsquamous). The researchers reported efficacy data with ≥2 years of follow-up at ASCO 2021. Clinical benefit was observed regardless of PD-L1 expression level and histology status. In the randomized phase 3 CheckMate-9LA trial, patients with advanced non–small-cell lung cancer (NSCLC) who were treated with first-line nivolumab (NIVO) plus ipilimumab (IPI) in addition to 2 cycles of chemotherapy experienced significantly improved overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR) compared with chemotherapy alone (4 cycles).
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