- GlaxoSmithKline and Merck KGaA have entered a joint development and commercialization pact for one of the latter company's investigational immuno-oncology drugs.
- M7824 is a fusion protein that targets two immune system-suppressing pathways, including the PD-L1 pathway that spawned blockbuster drugs like Keytruda and Opdivo. In the clinic, researchers have tested M7824 in almost 700 patients and across more than 10 tumor types, according to Merck KGaA. The drug is furthest along in advanced non-small cell lung cancer, where a Phase 2 study is evaluating it against Keytruda in patients who express PD-L1.
- Merck KGaA is taking home 300 million euros ($343 million) upfront through the GSK deal and could receive up to 3.4 billion euros ($3.9 billion) in milestone payments.
Tesaro gives GSK an early-stage PD-1 drug as well as a marketed product in Zejula (niraparib) — part of a class of therapies called PARP inhibitors that both industry and analysts see as quite valuable for cancer combination treatments.
The pipeline expansion clearly isn't complete, however. GSK's deal with Merck KGaA comes just two weeks after the Tesaro acquisition closed and underscores how the U.K. drugmaker, like many of its rivals, has a particular interest in immuno-oncology.
"I think 50 years from now we'll look at this as one of the most exciting things that ever happened in medicine, the advent of I/O," John Lepore, senior vice president of GSK's R&D pipeline, told BioPharma Dive in January at the J.P. Morgan Healthcare Conference.
M7824 targets both PD-L1 and a rising star in cancer drug development: a protein called TGF-beta. Just in the last few years, big pharmas such as Merck & Co., AstraZeneca and Eli Lilly have looked into how TGF-beta inhibition can treat cancer.
Tuesday's deal furthers the trend and supports the value potential of these therapies, according to Jefferies analyst Michael Yee.
"We wouldn't be surprised to see [Bristol-Myers Squibb, Merck & Co.] or Roche adding TGF-beta combos in their pipelines in the future in some way," Yee wrote in a Feb. 5 note on Scholar Rock Holding, a biotech with a preclinical TGF-beta drug that recently received interest from Gilead Sciences for its potential use in fibrotic diseases.
Meanwhile, M7824 already holds an important place in Merck KGaA's pipeline, as it's one of a few cancer drugs besides Bavencio (avelumab) to have reached mid-stage testing.
The Phase 2 trial assessing the drug against Keytruda (pembrolizumab) started in October and has a primary completion date set for October 2021.
GSK offered up to 500 million euros ($571 million) in milestone payments based on data from the M7824 lung cancer program. Another 2.9 billion euros ($3.3 billion) in milestone payments are tied to approval and commercial achievements.
Simon Sturge, chief operating officer at Merck KGaA, said in an emailed statement to BioPharma Dive that M7824 costs — from development and commercialization to registration and manufacturing — will be split 50/50 between his company and GSK.
He noted too that the 300 million euro upfront payment will support "priority pipeline molecules" at Merck KGaA, including M7824. The companies will evaluate the drug alone and in combos. Sturge said there are eight "high priority" immuno-oncology clinical development studies of M7824 ongoing or expected to commence in 2019.