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Merck closes in on first-line NSCLC label for Keytruda in US

Accelerated FDA review could see PD-1 inhibitor approved by the end of the year
Merck & Co.

Merck & Co could get FDA approval for first-line use of its PD-1 inhibitor Keytruda in lung cancer by the end of the year, after the FDA started a speedy review of the drug.

The FDA is planning to deliver a verdict on Keytruda (pembrolizumab) as a first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) whose tumours express PD-L1 by 24 December.

Approval in the first-line setting would mean Keytruda has leaped forward where its arch-rival in the PD-1 inhibitor space - Bristol-Myers Squibb's Opdivo (nivolumab) - took a tumble, with analysts now predicting that Merck will dominate the NSCLC market.

BMS' drug failed to meet its objectives in the phase III CheckMate-026 trial in first-line NSCLC thanks to an ambitious study design, which sought to show a benefit for the drug regardless of patients' PD-L1 status. That strategy worked well in the second-line setting and resulted in a broader label for Opdivo, allowing it to pull ahead in the marketplace, but has now backfired.

Opdivo pulled in $1.58bn in sales during the first half of 2016 compared to $563m for Keytruda, but Merck's drug is expected to gain ground quickly in NSCLC if the FDA clears first-line use.

Both drugs are still predicted to hit heady highs with analyst estimates of peak sales in the $8bn-$10bn range apiece, but Opdivo is no longer expected to be as dominant in the market.

Meanwhile, Opdivo and Keytruda are also expected to face competition in the coming months from Roche's PD-L1 inhibitor Tecentriq (atezolizumab), which is already on the market for bladder cancer and has just shown promising results in an NSCLC trial.

Merck's application is based on data from the Keynote-024 study, which showed that Keytruda improved progression-free survival (PFS) as well as overall survival compared with standard chemotherapy for NSCLC. The trial was stopped early so patients still on chemotherapy could switch to Keytruda if desired.

"Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with Keytruda compared to chemotherapy is welcome news," commented Merck's head of R&D Roger Perlmutter.

Along with second-line NSCLC, Opdivo is also approved for treating melanoma, renal cell carcinoma and classical Hodgkin's lymphoma, with an application in head and neck cancer under regulatory review. Keytruda has so far picked up approvals in melanoma, NSCLC, and head and neck squamous cell cancer.

Article by
Phil Taylor

8th September 2016

From: Regulatory

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