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.
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. An improvement in duration of response (DoR) was also observed. 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.
“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. “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. 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.”
“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. “This innovative regimen is built on the only approved dual immunotherapy foundation. The combination of Opdivo plus Yervoy has previously demonstrated long-term survival outcomes across multiple cancer types, including melanoma and renal cell carcinoma. We look forward to collaborating with a broad range of European stakeholders to bring this unique combination of two potentially synergistic immunotherapies with chemotherapy to eligible patients with lung cancer.”
This decision marks the third indication for an Opdivo plus Yervoy-based regimen in the EU, following previous approvals in metastatic melanoma and advanced renal cell carcinoma (RCC). In addition to the EU, the combination of Opdivo plus Yervoy with two cycles of chemotherapy has been approved in 11 countries, including the U.S., for the first-line treatment of patients with metastatic NSCLC.
“Access to innovative medicines is key to improve outcomes for people impacted by lung cancer,” said Anne-Marie Baird, president of Lung Cancer Europe (LuCE). “We are pleased to see new treatment options approved that may potentially help more people with metastatic non-small cell lung cancer.”
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -9LA clinical trial.
CheckMate -9LA Efficacy and Safety Results
In the CheckMate -9LA trial, an interim analysis with a minimum follow-up of 8.1 months for OS demonstrated:
- Opdivo plus Yervoy combined with two cycles of chemotherapy reduced the risk of death by 31% compared to chemotherapy alone [Hazard Ratio (HR): 0.69; 96.71% Confidence Interval (CI): 0.55 to 0.87; p=0.0006].
- Median PFS with the combination was 6.8 months compared to 5.0 months with chemotherapy alone (HR: 0.70; 97.48% CI: 0.57 to 0.86; p=0.0001).
- ORR was significantly higher for Opdivo plus Yervoy with two cycles of chemotherapy vs. chemotherapy alone: 38% vs. 25% (p=0.0003).
A subsequent analysis, with a minimum follow-up of 12.7 months, showed sustained improvements in OS compared to chemotherapy alone (HR: 0.66; 95% CI: 0.55 to 0.80).
The majority of select adverse reactions observed in patients who received Opdivo plus Yervoy with two cycles of chemotherapy were mild to moderate. Grade 3 or 4 treatment-related adverse events occurred in 47% of patients. The most frequent adverse reactions were fatigue (36%), nausea (26%), rash (25%), diarrhea (20%), pruritus (18%), decreased appetite (16%), hypothyroidism (15%) and vomiting (13%).
Source: Company Press Release