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BMS won't seek quick okay for Opdivo combo in lung cancer

No longer intends to file for accelerated approval, pushing predicted approval date back to late 2018

BMSBristol-Myers Squibb's hopes of carving out a slice of the first-line non-small cell lung cancer (NSCLC) market for its cancer immunotherapies have taken another knock.

The pharma company has said it no longer intends to file for accelerated approval for the combination of PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy in that indication, giving arch-rival Merck & Co further time to consolidate its lead in previously untreated NSCLC patients.

BMS said that after reviewing data on the combination it had decided to hold off for the moment, but "in order to protect the integrity of ongoing registrational studies … will not be providing additional details".

Analysts at Jefferies said that the delay to approval did not change forecasts for BMS' immuno-oncology portfolio, but they now expect a later approval for the Opdivo/Yervoy combination in the second half of 2018.

BMS' hopes of muscling into first-line NSCLC rest on the combination of Opdivo with Yervoy after Opdivo alone failed to meet its targets in the phase III CheckMate-026 trial, performing worse than chemotherapy.

The setback allowed Merck's PD-1 inhibitor Keytruda (pembrolizumab) to become the first - and so far unchallenged - immuno-oncology drug for front-line NSCLC treatment, albeit only for patients whose tumours express the PD-L1 biomarker. That lead could be further consolidated if Merck gets approval for the combination of Keytruda with chemotherapy, which has just been granted an accelerated review by the US FDA.

On their own, checkpoint inhibitors like Keytruda can generally only be used in up to a third of new NSCLC patients, so combination therapies are seen as the key to unlocking a much larger patient population.

Merck is seeking approval for 'all-comer' patients in its chemotherapy combination application, and other PD-1/PD-L1 inhibitor developers - including AstraZeneca and Roche - are taking a similarly inclusive approach.

Article by
Phil Taylor

20th January 2017

From: Regulatory



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