Bristol Myers Squibb’s (BMY) phase III study investigating its blockbuster drug Opdivo in combination with chemotherapy as *neoadjuvant treatment of resectable non-small cell lung cancer, dubbed CheckMate 816, has met the primary endpoint of pathologic complete response.
In the ongoing phase III trial, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for up to three doses, or platinum doublet chemotherapy alone every three weeks for up to three doses, followed by surgery.
A primary analysis of the trial has shown that significantly more patients treated with Opdivo plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate -816 is the first and only Phase 3 trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC, the company noted.
The other primary endpoint of event-free survival (EFS) and key secondary endpoints of the trial are yet to be assessed.
Bristol Myers’ Opdivo is approved for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.
In the second quarter ended June 30, 2020, Opdivo recorded sales of $1.65 billion, down 9% from the year-ago quarter.
* Neoadjuvant treatment is the treatment given before surgery.
BMY is currently trading at $58.44, up 1.22%.
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