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EMA starts review of Pfizer and Merck's PD-L1 inhibitor

Avelumab looks set to be the first new drug to treat Merkel cell carcinoma

EMAGerman Merck and Pfizer's bid to bring the fourth PD-1/PD-L1 inhibitor to market is now underway, with the EU regulator kicking off a review of avelumab for Merkel cell carcinoma.

The marketing application is based on the results of the JAVELIN Merkel 200 study which involved patients with the rare and aggressive skin cancer who had previously been treated with chemotherapy and were presented at this year's ASCO meeting.

In the trial, 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.

Merkel cell carcinoma can typically be treated with surgery if caught early, but the treatment options are "severely limited" for patients who have advanced disease at diagnosis, according to Luciano Rossetti, executive vice president, global head of R&D at the biopharma business of Merck.

If approved, avelumab will join Bristol-Myers Squibb's Opdivo (nivolumab), Merck & Co's Keytruda (pembrolizumab) and Roche's Tecentriq (atezolizumab) in the emerging checkpoint inhibitor class of cancer drugs, which are predicted to become a $30bn-plus market by 2022 thanks to unprecedented efficacy in a host of hard-to-treat cancers.

Avelumab looks set to be the first new drug to treat Merkel cell carcinoma, so initially at least will sidestep the fierce competition between the other drugs in indications such as non-small cell lung cancer (NSCLC).

"This is the first of what we hope will be many regulatory milestones for avelumab," said Chris Boshoff, senior vice president in charge of immuno-oncology at Pfizer. "We are committed to evaluating avelumab in a number of hard-to-treat cancers."

Merck and Pfizer have phase II and III trials of avelumab ongoing in NSCLC, renal cell carcinoma and ovarian, gastric and bladder cancer.

Despite the significant progress made with PD-1/PD-L1 inhibitors, the majority of patients do not respond to these drugs when given alone so combination use with other drugs is a key strategy for all their developers.

For example, Pfizer is looking at combining avelumab with two of its in-house immuno-oncology candidates, the 4-1BB (CD137) agonist utomilumab (PF-05082566) and OX40 agonist PF-04518600, as well as all three together as a triple anticancer regimen.

Pfizer paid Merck $850m upfront to jointly develop and market avelumab for multiple cancer indications in 2014. If all goes according to plan the deal could be worth up to $2.85bn to the German drugmaker.

Article by
Phil Taylor

1st November 2016

From: Regulatory

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