The combination of Opdivo plus Yervoy has previously demonstrated long-term survival outcomes across multiple cancer types, including melanoma and renal cell carcinoma. “This innovative regimen is built on the only approved dual immunotherapy foundation. “The European Commission’s approval of Opdivo plus Yervoy with two cycles of chemotherapy is an important milestone for patients with metastatic non-small cell lung cancer who face a difficult prognosis despite recent advances,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb.
Following today’s approval, clinicians in the EU will be able to offer patients a new option that may help achieve early disease control and improve survival.” “In the CheckMate -9LA trial, combining nivolumab and ipilimumab with two cycles of chemotherapy resulted in clinically meaningful overall survival benefits, which were consistent across patients with non-small cell lung cancer, regardless of PD-L1 expression levels or tumor histologies. “With a complex disease like metastatic non-small cell lung cancer, the availability of different treatment options is critical for patients, who have diverse needs and challenges,” said Martin Reck, M.D., Ph.D., CheckMate -9LA study investigator, Lung Clinic Grosshansdorf, German Center of Lung Research. The safety profile of Opdivo plus Yervoy and two cycles of chemotherapy was reflective of the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC. An improvement in duration of response (DoR) was also observed. The EC’s decision is based on results from the Phase 3 CheckMate -9LA trial, which met its primary endpoint of superior overall survival (OS), as well as secondary endpoints of progression-free survival (PFS) and overall response rate (ORR), for the combination of Opdivo plus Yervoy, given concomitantly with two cycles of chemotherapy, versus chemotherapy alone. The combination of Opdivo plus Yervoy with two cycles of chemotherapy is the first dual immunotherapy-based treatment option approved for patients in the European Union (EU) with this disease. Opdivo plus Yervoy -based combinations now indicated in the EU for three different advanced cancer types: non-small cell lung cancer, melanoma and renal cell carcinomaīristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.
CHECKMATE 9LA PUBLICATION TRIAL
The percentage of patients with grade 3 or 4 treatment-related adverse events in the overall population was 32.8% with nivolumab plus ipilimumab and 36.0% with chemotherapy.Approval based on Phase 3 CheckMate -9LA trial results showing superior overall survival in patients with metastatic non-small cell lung cancer, regardless of PD-L1 expression or tumor histologiesĮuropean Commission decision marks the first time a dual immunotherapy with limited chemotherapy is approved for patients with non-small cell lung cancer in the EU Among all the patients in the trial, the median duration of overall survival was 17.1 months (95% CI, 15.2 to 19.9) with nivolumab plus ipilimumab and 13.9 months (95% CI, 12.2 to 15.1) with chemotherapy. The overall survival benefit was also observed in patients with a PD-L1 expression level of less than 1%, with a median duration of 17.2 months (95% CI, 12.8 to 22.0) with nivolumab plus ipilimumab and 12.2 months (95% CI, 9.2 to 14.3) with chemotherapy. The median duration of response was 23.2 months with nivolumab plus ipilimumab and 6.2 months with chemotherapy. Among the patients with a PD-L1 expression level of 1% or more, the median duration of overall survival was 17.1 months (95% confidence interval, 15.0 to 20.1) with nivolumab plus ipilimumab and 14.9 months (95% CI, 12.7 to 16.7) with chemotherapy (P = 0.007), with 2-year overall survival rates of 40.0% and 32.8%, respectively.
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