Bristol Myers Squibb announces that the Phase 3 CheckMate-816 study has met the primary endpoint of improved disease-free survival (Efs) in patients with resectable non-small cell lung cancer (Nsclc) from stage IB to IIIA. In a predetermined interim analysis, nivolumab plus chemotherapy showed a statistically significant and clinically important improvement in disease-free survival compared to chemotherapy alone when administered before surgery. This association previously showed significant improvement in pathological complete response (pCR), another primary endpoint of the study. The safety profile of nivolumab plus chemotherapy was consistent with previously reported studies in Nsclc cancer. “Although the purpose of surgery is curative in resectable non-small cell lung cancer, between 30% and 55% of patients develop recurrence after surgery and ultimately surrender to the disease, confirming a strong need. of additional options that can break this cycle, “says Nicolas Girard, professor of respiratory medicine at Paris Saclay University and head of the Thorax Institute Curie Montsouris in Paris.” The positive disease-free survival data observed with neoadjuvant nivolumab plus chemotherapy are groundbreaking and may have important implications in the treatment of resectable non-small cell lung cancer. “” CheckMate-816 is the first Phase 3 study based on an immunotherapy combination that demonstrates a statistically significant and clinically important benefit as neoadjuvant therapy for patients with cancer. of the non-metastatic non-small cell lung ciation of nivolumab and chemotherapy initially showed a statistically significant improvement in the pathologic complete response rate, with no impact on surgery results, and has now prolonged the time patients live free from disease progression, relapse or death, ”says Abderrahim. Oukessou, vice president, thoracic cancers development lead, Bristol Myers Squibb. “Disease-free survival data from the CheckMate-816 study reinforce the evidence for the potential of nivolumab-based therapies to improve long-term, early-stage clinical outcomes in non-metastatic cancers.” available data from the CheckMate -816 study and aims to be able to share the results at an upcoming medical conference, as well as with health authorities. Previous results from the CheckMate-816 study were presented at the annual congresses of the American Association for Cancer Research (pathological complete response data) and the American Society of Clinical Oncology (surgical results) in 2021. In non-small cell lung cancer not metastatic, Bristol Myers Squibb and collaborators are investigating the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, and in association with chemoradiotherapy. The scientific rationale for the use of immunotherapy in the neoadjuvant setting is twofold: the presence of a tumor during immunotherapy therapy can allow for a greater immune response, potentially making treatment against a primary tumor more effective, while offering the opportunity to target occult micrometastases. Currently, nivolumab has shown greater efficacy in the neoadjuvant or adjuvant treatment of four types of cancers: lung, bladder, esophagus / gastroesophageal junction, and melanoma.
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