Drug Development

Merck, Incyte map a Phase III pipeline of their own for a frontline combo of Keytruda and epacadostat

Keytruda (pembrolizumab)

Last fall Incyte and Merck whipped up considerable enthusiasm for a match-up of their IDO1 enzyme inhibitor and Keytruda in an early-stage study of melanoma. They followed up with a commitment to expand their partnership to go after a range of cancers. And this morning the partners outlined aggressive plans to take the combo through seven pivotal trials.

Researchers for these two companies got excited about the potential for this combination after seeing progression-free survival rates of 74 percent and 57 percent at 6 months and 12 months among the advanced melanoma patients they treated last year in a Phase I. Their melanoma partnership was expanded to include a Phase III melanoma trial. Now they are pushing ahead in the clinic to see if Incyte’s epacadostat and Keytruda can make a significant difference in frontline use against non-small cell lung cancer, bladder cancer, renal cancer and squamous cell carcinoma of the head and neck (SCCHN).

Already in a Phase III melanoma study, investigators are adding:

• Two Phase III studies in first-line NSCLC, including both PD-L1 high-expressing and PD-L1 unselected populations.
• Two Phase III studies in bladder cancer, including one in first-line bladder cancer and one in second-line bladder cancer.
• A Phase III study in first-line RCC.
• And a Phase III study in first-line SCCHN.

Merck is managing the trial work while the two companies share expenses.

When RBC’s Simos Simeonidis saw the first cut of the Phase I data, he concluded that Incyte and Merck have an excellent shot of beating out Bristol-Myers Squibb’s pivotal combination study of Yervoy and Opdivo for first-line use in non-small cell lung cancer. And right now, Merck’s ability to maneuver past Bristol-Myers and seize the lead on NSCLC continues to stagger analysts.

Merck, of course, is sparing no expense in pushing dozens of pivotal studies of Keytruda, intent on capitalizing on a major market opportunity and unwilling to let a growing field of competitors hamper its pursuit of blockbuster revenue.

Most recently Pfizer and Merck KGaA gained an approval for the fourth checkpoint therapy — coming in right behind Roche — which unleashes an immune system attack on cancer cells. AstraZeneca, meanwhile, rejigged its development effort to amp up its work on a combination of durvalumab and tremelimumab.

Rivals in the field are paying rapt attention to every new move.

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