Incyte keeps the ASCO spotlight focused on its closely-watched IDO1 drug epacadostat

Steven Stein

CHICAGO — Typically, when you update your early-stage data with a couple of new complete responses to report, the biopharma world finds other things to focus on. But if you’re Incyte, with a $27 billion market cap $INCY centered on its lead IDO1 therapy epacadostat, the biopharma world will make an exception for you.

So it was on Saturday at ASCO, when Incyte adjusted the abacus on its non-small cell small combo lung cancer study for epacadostat and Keytruda, moving 2 of 14 responses reported recently in its ASCO abstract out of the partial side to the complete responses lineup.

That’s another positive note, and “it’s sort of a big deal in the setting,” Incyte CMO Steven Stein tells me.

Incyte is encouraged by the improvement as it tracks durability of the early-stage data. And while investigators aren’t making any predictions of what they’re going to see from here, says Stein, “it’s unlikely to get worse; it can only get better.”

The total response rate stayed the same in this study: 35%. That’s key here as the closest comparable monotherapy data Incyte follows is an 18% and 20% response rate (for squamous only lung cancer) for either Keytruda or Opdivo, respectively.

Incyte’s focus, along with the rest of the growing crowd following this company, will transfer now to the Phase III studies that Incyte is hammering out with the FDA, Merck and Bristol-Myers Squibb.

Stein says that response rate they’ve seen could improve as you move up to front-line use for treatment naive patients.

“Typically you expect higher response rates in the first-line setting in immuno-oncology,” says Stein, who followed Incyte CEO Hervé Hoppenot out of Novartis Oncology to the biotech. “This has been borne out across the board as you go from first- to third-line.”

Stein is reluctant to get into too much detail on how the late-stage studies will play out. That has to be worked out with regulators. But he notes that in lung cancer, where Merck recently won approval for a landmark Keytruda/chemo combo for first-line use, you have three key populations: High PD-L1 expressers, low PD-L1 expressers and significantly now all comers.

“We expect mechanistically to enhance the checkpoints,” adds Stein. “Where they have largest effect we would expect to have our largest effect and enhance those.”

Incyte has its own PD-1 drug, partnered with the Chinese biotech Jiangsu Hengrui Medicine with a $25 million upfront and $770 million in milestones. But Stein says that investigators recently noted evidence of hemangioma — noncancerous red spots that appear on the skin. It’s largely a “cosmetic” issue, he notes. But when there are “north of 30 publicly announced” checkpoint drugs which are all similar, it raises a question whether it might differentiate the drug in a negative way.

Incyte is agnostic about its alliances with the checkpoint leaders. It will follow the data wherever they lead.

“We feel it’s important to own one,” says Stein. “We think it will remain a backbone of doublet and maybe triplet treatment.”

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