GSK forms Keytruda combo trial pact as it plots path to 20 filings by 2020

GSK CEO Andrew Witty

GlaxoSmithKline ($GSK) has struck a deal to trial its anti-OX40 monoclonal antibody in combination with Merck's ($MRK) Keytruda. The Phase I study is part of a slate of programs that GSK is hoping will support filings for up to 20 new drug approvals in the coming years, the success rate of which will go a long way to deciding whether the company can bounce back from its recent travails.

Senior management laid out the strategy at an R&D event in New York today. With GSK having been hit by pipeline setbacks and reports of investor calls for the breakup of the business in recent weeks, the event presented CEO Andrew Witty with an opportunity to make the case that the company has a bright future--and that he is the man to take it there. A planned flurry of filings are central to the argument. GSK thinks it could file for approval of up to 20 new drugs by 2020. Respiratory, rare disease, oncology and HIV are all well represented in the filing plan.

In the near term--which, given the pressure on GSK, is vital--management is looking to severe asthma treatment Nucala to support revenue growth. The FDA is due to make an approval decision imminently, potentially setting GSK up to treat patients with eosinophilic inflammation who are poorly served by existing options such as Novartis' ($NVS) Xolair. Though with GSK guiding that fewer than 400,000 patients in the U.S. fall into the target demographic, the numbers are relatively small. GSK is looking to shingles vaccine Shingrix and rheumatoid arthritis treatment sirukumab to take up some of the slack if sales of Advair fall as expected in the coming years.

The trial testing the humanized IgG1 anti-OX40 monoclonal antibody GSK3174998 in combination with Merck's Keytruda forms part of GSK's pitch for midterm approvals. GSK has penciled a filing for GSK3174998 in for between 2018 and 2020, a two-year period that could prove critical for its oncology ambitions. Including GSK3174998, which emerged from a collaboration with MD Anderson Cancer Center, GSK is planning to file for approval of 6 oncology drugs between 2018 and 2020. In total, GSK is aiming to have 11 NMEs ready for that window.

Beyond 2020, GSK is looking to a clutch of respiratory and immuno-inflammation drugs to drive growth. Management expects to file for approval of 9 respiratory drugs and 8 inflammation candidates from 2021 to 2025. That period is when GSK is aiming to file for approval of hepatitis C drug GSK2878175, too. GSK put another piece of that strategy in place ahead of the R&D day when it teamed up with Regulus Therapeutics ($RGLS) to trial GSK2878175 in combination with RG-101. GSK sees the combination as a one-shot cure for whoever still has hepatitis C patients by the time it comes to market.

- read the R&D day release
- here's the Keytruda news
- check out Reuters' take
- and GSK's presentation (PDF)