Is Opdivo + Chemotherapy Effective for Lung Cancer?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
From March 29 to April 1, 2023, Martin Reck and colleagues from Lung Clinic Grosshansdorf presented the long-term follow-up results for efficacy, safety, and event-free survival (EFS) from the Phase 3 CheckMate 816 clinical trial at the European Lung Cancer Congress (ELCC) in Copenhagen, Denmark. This trial evaluated neoadjuvant Opdivo plus chemotherapy in patients with early-stage non-small cell lung cancer (NSCLC).
CheckMate 816 is a multi-center, randomized, open-label Phase 3 trial. Resectable NSCLC patients (N=358) were randomized to either the Opdivo (360mg) + chemotherapy group (every 3 weeks for up to 3 cycles, N=179) or the chemotherapy-only group (every 3 weeks for up to 3 cycles, N=179). The primary endpoints were pathological complete response (pCR) and event-free survival (EFS), while secondary endpoints included overall survival (OS), major pathological response (MPR), and time to distant metastasis or death.
In this long-term follow-up, for patients who underwent minimally invasive surgery, the 3-year EFS rates were 67% in the Opdivo + chemotherapy group versus 53% in the chemotherapy group. For patients who underwent thoracoscopy or open surgery, the 3-year EFS rates were 61% in the Opdivo + chemotherapy group versus 51% in the chemotherapy group. These results show that both groups of patients had a higher 3-year EFS rate with neoadjuvant Opdivo + chemotherapy. Additionally, the recurrence rate for patients who underwent surgery was lower in the Opdivo + chemotherapy group (28%) compared to the chemotherapy group (42%).
The median EFS was not reached in the Opdivo + chemotherapy group, while it was 21.1 months in the chemotherapy group. The risk of disease progression or death was reduced by 32%.
Based on the results of the CheckMate 816 trial, Martin Reck stated: "These data are very important and represent a significant advance in curing patients with early-stage non-small cell lung cancer (NSCLC)."
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