Bristol Myers Squibb’s PD-1 inhibitor Opdivo has scored a new win in the pre-surgery, non-small cell lung cancer (NSCLC) setting.
Data presented at the virtual American Association for Cancer Research (AACR) annual meeting showcased results from the CheckMate-816 study, which evaluated Opdivo (nivolumab) plus chemotherapy in patients with early-stage NSCLC before surgery.
The primary endpoints of the study were pathological complete response (pCR), defined as no residual viable tumour in the resected lung specimen and the sampled lymph node after surgery and event-free survival (EFS).
Researchers found that Opdivo plus chemotherapy increased the pCR rate to 24% in the intent-to-treat population, compared to just 2.2% of patient treated with chemotherapy alone.
In patients with resection, the pCR rate increased further to 30.5% for those receiving the Opdivo/chemotherapy combination, compared to 3.2% in patients receiving chemotherapy alone.
The improvement in pCR was consistent across subgroups, including disease stage, NSCLC subtype, PD-L1 status, tumour mutational burden status and gender.
The administration of Opdivo also did not affect patients’ eligibility to receive definitive surgery – 83.2% in the Opdivo/chemotherapy arm compared to 75.4% of patients in the chemotherapy alone arm.
In addition, the pre-surgery objective response rate on imaging in the Opdivo combination arm was 53.6% compared with 37.4% in the chemotherapy arm, with radiographic down-staging rates of 30.7% compared with 23.5% respectively.
“CheckMate-816 is the first phase 3 trial to show a benefit of neoadjuvant chemotherapy plus chemo and this has the potential to represent a new neoadjuvant treatment option for patients with early-stage, resectable non-small cell lung cancer,” said Patrick Forde, associate professor, Sidney Kimmel Comprehensive Cancer Center and Bloomberg Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University.
Although Merck & Co’s rival checkpoint inhibitor Keytruda (pembrolizumab) is dominant in the NSCLC setting, it does not possess similar results in the pre-surgery, neoadjuvant setting.
With the CheckMate-816 results in hand, Opdivo could gain an advantage over Keytruda in the early-stage setting, although BMS did not disclose its plans for regulatory approval during the AACR presentation.
However, Forde did note that the study will continue to mature for data from the EFS co-primary endpoint – again, the timeline for this was not disclosed.