Ono Pharmaceutical said Taiwan’s Food and Drug Administration has approved Opdivo intravenous infusion in combination with chemotherapy before surgery and as a single-agent treatment after surgery for certain adults with resectable non-small cell lung cancer.
The approval, announced Aug. 19, covers adults with tumors measuring at least 4 centimeters or node-positive resectable NSCLC who have no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. Patients will receive Opdivo, or nivolumab, with platinum-doublet chemotherapy before surgery, followed by surgery and adjuvant Opdivo monotherapy.
Ono Pharma Taiwan, Ono Pharmaceutical’s Taiwanese subsidiary, received the additional approval from the TFDA on Aug. 19.
The decision was based on the Phase 3 CheckMate-77T trial, which evaluated the perioperative regimen against neoadjuvant platinum-doublet chemotherapy and placebo, followed by surgery and adjuvant placebo. The study enrolled 461 patients with resectable stage IIA to IIIB NSCLC.
The Opdivo regimen demonstrated a statistically significant and clinically meaningful improvement in the trial’s primary endpoint of event-free survival, as assessed by blinded independent central review, Ono said. It also showed clinically meaningful improvements in secondary endpoints of pathologic complete response and major pathologic response.
The safety profile of the Opdivo group was consistent with previous studies in NSCLC, and no new safety signals were identified, the company said.
NSCLC is the most common form of lung cancer, accounting for approximately 80% to 85% of cases. In Taiwan, an estimated 20,000 people are newly diagnosed with lung cancer each year, and approximately 10,000 die from the disease annually, making it the leading cause of cancer-related death in the market.
While surgery can be used alone for some patients with non-metastatic, early-stage NSCLC, Ono said 30% to 55% of patients may experience recurrence. Treatment before surgery, known as neoadjuvant therapy, and after surgery, known as adjuvant therapy, may help improve longer-term outcomes.
Opdivo is a PD-1 immune checkpoint inhibitor designed to restore anti-tumor immune response by blocking interactions between PD-1 and its ligands. The medicine is approved in more than 65 countries. Ono Pharma Taiwan has marketed Opdivo in Taiwan since 2016.
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