Merck steals march on rivals in lung cancer drug combo race

Merck steals march on rivals in lung cancer drug combo race Merck & Co has pulled ahead of rivals in the race to combine immunotherapy with other drugs as a treatment for lung cancer, potentially giving it a major lift in the battle for the largest cancer market. U.S. regulators have agreed to a speedy review of Merck's application to combine its immune system-boosting drug Keytruda with

chemotherapy as an initial therapy for advanced lung cancer, the U.S. drugmaker said.

Shares in AstraZeneca, which is developing a dual-immunotherapy approach, fell around 1 percent in early trade on Wednesday, while Roche, which is looking to add chemotherapy like Merck, slipped 0.6 percent.

Merck said the U.S. Food and Drug Administration (FDA) would decide by May 10 whether to approve its Keytruda combination treatment, sending the company's stock more than 3 percent higher in after-hours trading.

Bristol-Myers Squibb is also working on an immunotherapy-based combination approach for lung cancer.

Immunotherapy is revolutionising some areas of cancer care but giving it on its own only seems to work better than chemotherapy in previously untreated lung cancer patients who have high levels of a protein called PD-L1.

Since just a quarter to a third of non-small cell lung cancer (NSCLC) patients have tumours with at least 50 percent of cells producing PD-L1, around 70 percent of the market is still up for grabs for successful combination products.

Analysts at Evercore ISI estimate the market for first-line lung cancer for all patients could be as high as $14 billion.

Although Merck presented good results from a mid-stage Phase II trial for its Keytruda-chemotherapy combination at conference in Denmark in October, many analysts had thought it would need to wait for data from a larger Phase III study before filing.

"This comes as an important surprise because if FDA approves the application, Merck would suddenly be catapulted ahead of all other (immunotherapy) competitors who are also pursuing competing combination regimens of their own," said Bernstein analyst Tim Anderson.

Merck had not previously indicated that it was close to filing for the combination therapy and analysts had been looking for this news toward the end of 2017.