Opdivo plus Yervoy combined with two cycles of chemotherapy as first-line treatment of metastatic non-small cell lung cancer, positive CHMP opinion
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has recommended approval of Opdivo ( Nivolumab ) plus Yervoy ( Ipilimumab ) with two cycles of Platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer ( NSCLC ) in adults whose tumors have no sensitizing EGFR mutation or ALK translocation.
The CHMP adopted the positive opinion based on results from the phase 3 CheckMate -9LA trial, which met the primary endpoint of superior overall survival ( OS ).
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.
CheckMate -9LA is an open-label, multi-center, randomized trial evaluating Nivolumab ( 360 mg Q3W ) plus Ipilimumab ( 1 mg/kg Q6W ) combined with histology-based chemotherapy ( two cycles ) compared to chemotherapy alone ( up to four cycles followed by optional Pemetrexed maintenance therapy if eligible ) as a first-line treatment in patients with metastatic non-small cell lung cancer regardless of PD-L1 expression and histology.
Patients in the experimental arm ( n=361 ) were treated with dual immunotherapy for up to two years or until disease progression or unacceptable toxicity.
Patients in the control arm ( n=358 ) were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance ( if eligible ) until disease progression or unacceptable toxicity.
The primary endpoint of the trial was overall survival in the intent-to-treat ( ITT ) population. Secondary hierarchical endpoints included progression-free survival ( PFS ) and overall response rate ( ORR ) as assessed by blinded independent review committee.
Exploratory analyses from the study evaluated efficacy measures according to biomarkers.
Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell.
Non-small cell lung cancer is one of the most common types of lung cancer and accounts for up to 84% of diagnoses.
Survival rates vary depending on the stage and type of the cancer when diagnosed. For patients diagnosed with metastatic non-small cell lung cancer, the five-year survival rate is approximately 6%. ( Xagena )
Source: BMS, 2020