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FDA starts speedy review of Merck/Pfizer's PD-L1 inhibitor

If approved avelumab would be first approved cancer immunotherapy for metastatic MCC

Merck KGaA new brand 

Pfizer and Merck KGaA have moved closer to bringing the fourth checkpoint inhibitor to the US market after the FDA granted a priority review for the drug in a rare form of skin cancer.

If all goes to plan, the PD-L1 inhibitor could be approved for Merkel cell carcinoma (MCC) in the first half of 2017, setting it up to reach the market ahead of AstraZeneca's durvalumab which has been hit by some delays in its late-stage testing and a decision to focus on combination therapy. A few weeks ago the EMA started its review of avelumab for the same indication.

The marketing application is based on the results of the JAVELIN Merkel 200 study, in which avelumab achieved an objective response rate (ORR) of 32%, with around 9% of patients seeing a complete response to the treatment. After a follow-up of 10.4 months, 82% of patients continued to respond to therapy.

None of the three already-approved checkpoint inhibitors – Bristol-Myers Squibb's Opdivo (nivolumab), Merck & Co's Keytruda (pembrolizumab) and Roche's Tecentriq (atezolizumab) – are approved for MCC so avelumab could benefit from a competition-free roll-out in its first indication.

Merck and Pfizer also have phase II and III trials of avelumab ongoing in non-small cell lung cancer, renal cell carcinoma and ovarian, gastric and bladder cancer.

Pfizer paid Merck $850m upfront to jointly develop and market avelumab for multiple cancer indications in 2014, and the deal could be worth up to $2.85bn to the German drugmaker if avelumab's roll-out proceeds as planned.

Having avelumab under regulatory review on both sides of the Atlantic is a boost for both Merck and Pfizer, as the drug is central to both their plans in the coming years. For Merck – which has gone a long time without a major product launch – the checkpoint inhibitor is the core of a block of new launches expected to add €2bn in sales by 2022.

Meanwhile, Pfizer bought into the programme after missing out on the emerging immuno-oncology movement in pharma, despite its established heritage in cancer therapy. The company has been buying in assets to flesh out its oncology portfolio, and in addition to avelumab also acquired Medivation for $14bn to add prostate cancer treatment Xtandi (enzalutamide) and phase III PARP inhibitor candidate talazoparib.

"There are currently no approved treatment options for metastatic MCC, and we are committed to working with the FDA to potentially bring the first approved cancer immunotherapy to patients with this aggressive disease," commented Merck's R&D chief Luciano Rossetti.

Article by
Phil Taylor

30th November 2016

From: Research

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