Merck KGaA and Pfizer enter the immunotherapy market with Bavencio

pharmafile | March 27, 2017 | News story | Sales and Marketing Bavencio, Merck KGaA, Pfizer 

Merck KGaA and Pfizer have won approval for the fourth immunotherapy treatment to enter the market, with an indication in metastatic Merkel cell carcinoma (mMCC) for their drug, Bavencio (avelumab). The drug enters the market much later than now-rivals BMS and MSD’s drugs (Opdivo and Keytruda, respectively), and 10 months after Roche’s Tecentriq.

Bavencio has some catching up to do, in terms of indications, but the nod from the FDA for the drug comes as a welcome milestone for Merck KGaA – it is the first drug approval the company has had in a decade. There is also plenty of space left in the immunotherapy market, as evidenced by their first approval for the drug, coming as the first time patients with mMCC can be treated by immunotherapy.

The approval was based on a single-arm trial of 88 patients with mMCC, who had previously been treated with at least one prior chemotherapy regimen. 33% of patients experienced complete or partial shrinkage of their tumours while, of those who experienced a response, 86% maintain this response for more than six months and further 45% also maintained a response 12 months later.

“At the heart of this FDA approval is our drive to make a meaningful difference for patients with hard-to-treat cancers like metastatic Merkel cell carcinoma,” said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck. “Bavencio’s journey has included years of hard work – from the scientists who discovered this molecule in our labs, to our alliance with Pfizer and to the study participants and investigators worldwide. We are grateful to all who have made it possible for us to bring this important new treatment option to patients.”

The alliance with Pfizer was made back in 2014, with Merck KGaA having received $850 million up-front and having the potential to receive a further $2 billion in commercial milestones. The partnership meant that both companies funded the development of the drug and will share marketing costs.

Estimates on how much the drug could be worth to both companies are varied, with some slating the drug to make peak sales of $1.2 billion, all the way up to $6 billion. A lot will depend on what indications the drug can achieve, and it is already thought to be undergoing trials in the lucrative lung cancer market.

Ben Hargreaves

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