Bristol-Myers Squibb (BMS) has reported positive results from two pivotal trials CheckMate -017 and -063 evaluating opdivo in previously treated squamous (SQ) non-small cell lung cancer (NSCLC).
The longer term survival and safety data showed sustained survival benefit across both the trials.
Opdivo showed an estimated 18 month overall survival (OS) rate of 27% in CheckMate -063 to 28% in CheckMate -017, while survival benefit was independent of PD-L1 expression.
The company noted that the safety profile of the drug is consistent with previously reported trials, and in CheckMate -017, is also favourable compared to docetaxel.
Both the trials have showed the efficacy and safety of Opdivo in patients with advanced or metastatic SQ NSCLC who had progressed following previous chemotherapy treatment.
Jointly, the trials examined Opdivo monotherapy at a dose of 3mg / kg every two weeks, which has been well-established across the Phase III Opdivo clinical development programmes for several tumors.
According to the company, the trials also formed the basis for Opdivo’s approvals in the US and EU , and helped to establish the agent as standard of care for previously treated SQ NSCLC.
Bristol-Myers Squibb Oncology head of development and senior vice-president Michael Giordano said: "Our approach to Immuno-Oncology research is intended to show meaningful improvement over the traditional standard of care on the benchmark endpoint of overall survival.
"We have taken a comprehensive research approach in lung cancer, one focused on a commitment to providing the first major advancement in squamous non-small cell lung cancer in more than a decade – Opdivo – that offers the potential to replace chemotherapy.
"With the data presented today, we remain confident in our Immuno-Oncology strategy, including fulfilling our goal in showing the survival benefit for Opdivo, not only in non-small cell lung cancer, but similar to the data already observed in advanced melanoma and other tumor types."
CheckMate -017 is an open-label, randomised Phase III trial that evaluated Opdivo 3mg/kg intravenously over 60 minutes every two weeks versus standard of care, docetaxel 75mg / m² intravenously administered every three weeks in patients with advanced SQ NSCLC.
The other study, CheckMate -063 is a single-arm, open-label Phase II trial that included patients with metastatic SQ NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic treatment regimen.