EMA Begin Review of Pfizer & Merck’s Avelumab for Merkel Cell Carcinoma

pfizer_merckMerck and Pfizer’s bid to bring PD-1/PD-L1 inhibitor to market is now proceeding, after the EU regulator kicked off a review of avelumab for Merkel cell carcinoma.

The drug’s marketing application is based on the results from the JAVELIN Merkel 200 study which were presented at this year’s ADCO meeting, from patients with the rare and aggressive skin cancer who had previously been treated with chemotherapy.

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 be treated with surgery if caught early, however the treatment options are “severely limited” for patients who have advanced disease at diagnosis, per 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, Merck & Co’s Keytruda and Roche’s Tecentriq in the emerging checkpoint inhibitor class of cancer drugs, which are forecasted to become a $30bn-plus market by 2022 thanks to the efficacy in a host of hard-to-treat cancers.

Avelumab appears to be the first new drug to treat Merkel cell carcinoma, so it will initially 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 significant progress made with PD-1/PD-L1 inhibitors, most 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.


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