BMS obtains FDA approval for Opdivo combo for non-small cell lung cancer – Pharmaceutical Technology

In a Phase III trial, Opdivo plus chemotherapy provided a 37% decline in the progression, recurrence or mortality risk.
The US Food and Drug Administration (FDA) has granted approval to Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) plus platinum-doublet chemotherapy for adult resectable non-small cell lung cancer (NSCLC) patients in the neoadjuvant setting.
According to the approval, a 360mg intravenous dose of Opdivo should be used along with platinum-doublet chemotherapy every three weeks for three cycles for resectable NSCLC patients with tumours ≥4cm or node-positive.
BMS noted that the treatment is approved for usage irrespective of the status of programmed Cell Death Ligand 1 (PD-L1).
The latest FDA approval is based on positive data from the randomised, open-label Phase III CheckMate -816 clinical trial of Opdivo plus chemotherapy compared to chemotherapy alone in 358 resectable NSCLC patients.
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Event-free survival (EFS) and pathologic complete response (pCR) were the primary endpoints while overall survival (OS) was the trial’s further efficacy outcome measure.
Findings showed that treatment with Opdivo plus chemotherapy before surgery offered a statistically significant improvement in EFS.
The combination therapy was demonstrated to provide a 37% decline in the progression, recurrence or mortality risk versus chemotherapy alone.
A median EFS of 31.6 months was observed in the Opdivo plus chemotherapy arm versus 20.8 months in those treated with chemotherapy alone.
Furthermore, 24% of patients who received the combination treatment attained pCR versus 2.2% of subjects who received only chemotherapy.
An interim assessment for OS yielded an HR of 0.57, which did not exceed the statistical significance threshold.
Bristol Myers Squibb US Cardiovascular, Immunology and Oncology senior vice-president and general manager Adam Lenkowsky said: “At Bristol Myers Squibb, we are leading innovative science in the use of immunotherapy in earlier stages of cancer and are committed to bringing these options to patients. 
“Today’s approval builds on that commitment and expands the role of Opdivo-based treatment in NSCLC, the most common form of lung cancer, so patients may benefit earlier in the course of their disease.”
In August last year, the FDA approved BMS’ Opdivo as adjuvant therapy for urothelial carcinoma patients at high recurrence risk after radical resection.
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