Merck KGaA and Pfizer Inc. to co-develop anti-PD-LI antibody

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MERCK KGAA and Pfizer Inc. will co-develop and co-commercialize MSB0010718C, an investigational anti-PD-L1 antibody currently in development by Merck KGaA as a potential treatment for multiple tumor types.\

The asset will be developed as a single agent as well as in various combinations with the two companies’ portfolios of drug candidates. The two companies will also advance Pfizer’s anti-PD-1 antibody into phase I trials. As part of the agreement, Merck KGaA will co-promote Pfizer’s Xalkori for the treatment of non-small cell lung cancer.

“Up to 20 high priority immuno-oncology clinical development programs are expected to commence in 2015, including pivotal registration studies,” said Belén Garijo, president and CEO of the biopharmaceutical division of Merck KGaA. There are currently two clinical development programs underway evaluating MSB0010718C.

In a phase I trial, more than 550 patients have been treated with the drug across multiple types of cancers, with interim data demonstrating a complete response and partial responses in patients with non-small cell lung cancer and ovarian cancer. Additional data are expected to be presented at medical congresses in 2015.

There is also an ongoing phase II trial evaluating this antibody in patients with m-Merkel cell carcinoma.

Under the terms of the agreement, Merck KGaA will receive an upfront payment of $850 million and is eligible to receive regulatory and commercial milestone payments up to $2 billion. Both companies will jointly fund all development and commercialization costs, and all revenues obtained from selling any anti-PD-L1 or anti-PD-1 products generated from this collaboration will be shared.

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