CHECKMATE 227 PLUS

CHECKMATE 227 PLUS

In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. In Checkmate 057, fatal adverse reactions occurred these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure.

In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). Fatal adverse reactions occurred in 1.7% of patients these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). No fatal adverse reactions occurred in patients who received OPDIVO in combination with platinum-doublet chemotherapy.

In an exploratory analysis of patients with PD-L1 expression 2% included pneumonia and vomiting. In the primary endpoint population of patients with tumor PD-L1 expression ≥1%, the five-year survival rate for Opdivo plus Yervoy was 24%, compared to 14% for chemotherapy (Hazard Ratio 0.77 95% Confidence Interval : 0.66 to 0.91). With a minimum follow-up of over five years (61.3 months), the longest reported for an immunotherapy combination in mNSCLC: Bristol Myers Squibb (NYSE: BMY) today announced five-year results from Part 1 of the Phase 3 CheckMate -227 trial, which continues to demonstrate long-term, durable survival benefits of first-line treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to chemotherapy in patients with metastatic non-small cell lung cancer (mNSCLC), regardless of PD-L1 expression levels.