The acquisition of Tesaro and a codevelopment deal with Merck KGaA has helped double the size of GlaxoSmithKline’s clinical oncology pipeline from eight to 16.
Earlier this week, GSK formed an alliance with Germany’s Merck to codevelop and commercialize a bifunctional fusion protein immunotherapy intended to treat multiple cancers. Merck has received an upfront payment of €300 million ($340 million) from GSK and could receive a further €500 million in development milestone payments.
The candidate, M7824 (proposed International Nonproprietary Name bintrafusp alfa), is in Phase I studies for solid tumors and a Phase II trial to compare the product with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced NSCLC.
“M7824 has been tested in 14 phase 1b signal seeking studies across more than 700 patients, and has shown clinical activity across multiple hard to treat cancers, including non-small cell lung cancer, HPV associated cancers, biliary tract cancer and gastric cancer,” Hal Barron, president of R&D and CSO at GSK said during the firm’s Q4 financial call yesterday.
“Together with Merck, we will explore the potential of this novel asset alone and in various combinations with the four immuno-oncology clinical development phase ongoing or expected to commence in 2019.”
The deal comes a fortnight after GSK completed the $5.1 billion acquisition of Tesaro, a Massachusetts-based firm with a commercial product Zejula (niraparib) – an oral poly ADP ribose polymerase (PARP) inhibitor currently approved for use in ovarian cancer – and four clinical stage candidates.
“Overall, we have significantly strengthened our oncology portfolio,” Barron said. “Since Q2, we have added three new internally generated assets to the portfolio and through business development added five, four from the Tesaro acquisition and one from the strategic alliance with Merck to jointly develop and commercialize M7824, resulting in a doubling of the size of our oncology clinical stage portfolio from eight to 16.”
Emma Walmsley, CEO, added GSK’s “number one priority is to up the value from the various deals that we’ve done,” and highlighted the Merck alliance as “exactly the kind of thing that we want to continue to do, whether it be on assets or technology platforms.”
For the full year 2018, GSK reported flat pharmaceuticals sales of £17.2 billion ($22.2 billion), while the vaccine business pulled in £5.9 billion, up 14% year-on-year due to demand for Shingrix in the US and growth in influenza and Hepatitis vaccine.