Bristol-Myers Squibb announced three-year overall survival (OS) data from CheckMate -017 and CheckMate -057, two pivotal Phase 3 randomized studies evaluating Opdivo versus docetaxel in patients with previously treated metastatic non-small cell lung cancer (NSCLC). In CheckMate -017, a trial in previously treated squamous NSCLC, 16% of patients treated with Opdivo were alive at three years (21/135) versus 6% of those treated with docetaxel (8/137) (HR 0.62; 95% CI: 0.48 to 0.80). In CheckMate -057, a trial in previously treated non-squamous NSCLC, 18% of patients treated with Opdivo were alive at three years (49/292) versus 9% of those treated with docetaxel (26/290) (HR 0.73; 95% CI: 0.62 to 0.88). Similar to prior reports, an OS benefit was observed across histologies, and three-year survivors included patients whose tumors expressed PD-L1 and those that did not. With three years’ minimum follow-up, no new safety signals were identified for Opdivo, and the safety profile across both trials was consistent with prior reports.
“Our utmost priority at BMS is to bring forth transformational medicines to deliver what matters most to patients fighting cancer: long-term survival. The long-term survival benefit seen with Opdivo in the pivotal CheckMate -017 and -057 studies demonstrates our commitment to this vision,” Nick Botwood, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, said. “These data also increase our understanding of the value Opdivo may bring to patients with previously treated metastatic NSCLC, as we continue to explore Opdivo alone and in combination with other agents across a range of thoracic cancers.”
CheckMate -017 and CheckMate -057 are two pivotal Phase 3, open-label, randomized clinical trials that evaluated Opdivo 3 mg/kg every two weeks versus standard of care, docetaxel 75 mg/m2 every three weeks, in patients with advanced NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. CheckMate -017 included 272 patients with squamous NSCLC, and CheckMate -057 included 582 patients with non-squamous NSCLC. Both trials enrolled patients across PD-L1 expression levels. The primary endpoint for both trials was overall survival (OS), and secondary endpoints included objective response rate (ORR), progression-free survival (PFS) and efficacy by tumor PD-L1 expression.
In both studies, the OS benefit for Opdivo was observed across PD-L1 expression levels, including patients with PD-L1 expression <1%. Among Opdivo-treated patients with squamous NSCLC in CheckMate -017, 13% (7/54) with PD-L1 expression <1% and 14% (9/63) with PD-L1 expression ≥1% were alive at three years. In non-squamous NSCLC patients treated with Opdivo in CheckMate -057, 11% (11/108) with PD-L1 expression <1% and 26% (29/123) with PD-L1 expression ≥1% were alive at three years.
The safety profile of Opdivo remained consistent with previous reports of data from both pivotal trials. In the pooled safety analysis, at three years, 10.5% of Opdivo-treated patients experienced Grade 3/4 treatment-related adverse events (AEs). The most common treatment-related AEs of any grade in patients treated with Opdivo included fatigue (17%), nausea (11%), decreased appetite (11%), asthenia (10.5%), pruritus (6.9%) and vomiting (5%).
Lung cancer is the leading cause of cancer deaths globally, resulting in nearly 1.7 million deaths each year, according to the World Health Organization. NSCLC is one of the most common types of the disease and accounts for approximately 85% of diagnoses. About 25% to 30% of all lung cancers are squamous cell carcinomas, and non-squamous NSCLC accounts for approximately 50% to 65% of all lung cancer diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. Globally, the five-year survival rate for patients with Stage I NSCLC is between 47% and 50%, and for Stage IV NSCLC, the five-year survival rate drops to 2%.