Bristol Myers Squibb has received the US Food and Drug Administration (FDA) approval for Opdivo (nivolumab) to treat adult patients with resectable non-small cell lung cancer (NSCLC).
The PD-1 immune checkpoint inhibitor has been approved as a neoadjuvant therapy combined with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant therapy after surgery.
The approval is for the treatment of NSCLC patients with no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
Bristol Myers Squibb announced the acceptance of regulatory filings for neoadjuvant nivolumab in the US and Europe in February this year.
Bristol Myers Squibb US oncology and haematology senior vice president Wendy Bartie said: “This milestone expands the role of Opdivo -based treatments and builds upon the foundation set by the FDA approval of neoadjuvant-only Opdivo plus chemotherapy in resectable NSCLC based on the CheckMate-816 trial.
“With this new Opdivo-based regimen, we are reinforcing our commitment to helping improve patient outcomes and expanding our thoracic portfolio in early-stage disease.”
The approval is based on the CheckMate-77T trial, the company’s second positive Phase 3 trial using an immunotherapy combination for resectable NSCLC.
CheckMate-77T is a randomised, double-blind, placebo-controlled multicentre trial in 461 patients.
The individuals were randomised 1:1 to receive nivolumab or placebo, with platinum-based chemotherapy.
Results showed that the Opdivo group improved event-free survival (EFS), a primary endpoint, compared to the chemotherapy and placebo group.
Additionally, a high pathologic complete response (pCR) rate was observed as a pre-specified secondary endpoint.
In the nivolumab treatment group, the risk of disease recurrence, progression, or death was reduced by 42% compared to the chemotherapy and placebo group.
Eighteen-month EFS was 70% in the Opdivo group, versus 50% in the chemotherapy and placebo group.
In 2011, Bristol Myers Squibb entered into a collaboration agreement with Ono Pharmaceutical for the development and commercialisation of Opdivo globally, with the exception of Japan, South Korea, and Taiwan.
The FDA had previously approved the PD-1 inhibitor for adult patients with resectable NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.
Opdivo and its combinations have received FDA approval for lung cancer, melanoma, bladder cancer, and oesophageal/ gastroesophageal junction cancer.
In August, Bristol Myers Squibb announced that the US health agency had accepted its regulatory application for Opdivo with Yervoy (ipilimumab) to treat adult patients with unresectable hepatocellular carcinoma (HCC).
