CheckMate -816 trial: Nivolumab plus chemotherapy has shown statistically significant improvement in pathologic complete response as neoadjuvant treatment of resectable non-small cell lung cancer
The phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response ( pCR ) in resectable non-small cell lung cancer ( NSCLC ).
In the trial, significantly more patients treated with Nivolumab ( 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.
Patients in the experimental arm of the trial received up to three doses of Nivolumab plus chemotherapy prior to surgery, a standard number of cycles of therapy in the neoadjuvant setting.
The safety profile of Nivolumab plus chemotherapy was consistent with previously reported studies in NSCLC.
CheckMate -816 is a phase 3 randomized, open label, multi-center trial evaluating Nivolumab plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable non-small cell lung cancer.
For the primary analysis, 358 patients were randomized to receive either Nivolumab 360 mg plus histology-based Platinum doublet chemotherapy every three weeks for up to three doses, or Platinum doublet chemotherapy every three weeks for up to three doses, followed by surgery.
The primary endpoints of the trial are pathologic complete response ( pCR ) and event-free survival. Key secondary endpoints include overall survival ( OS ), major pathologic response ( MPR ) and time to death or distant metastases.
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 ( NSCLC ) is one of the most common types of lung cancer, representing up to 84% of diagnoses.
Non-metastatic cases account for the majority of NSCLC diagnoses ( approximately 60% ). While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery ( neoadjuvant ) and/or after surgery ( adjuvant ) to improve long-term outcomes. ( Xagena )
Source: BMS, 2020