IDEAYA and Servier’s eye cancer drug meets trial goal, paving way for FDA application

By Puyaan Singh

April 13 (Reuters) – IDEAYA Biosciences and French pharma company Servier said on Monday their combination drug for a type of eye cancer met the main goal ​of a mid-to-late-stage trial, sending the U.S. biotech’s ‌shares 21% higher.

IDEAYA will now apply for the U.S. Food and Drug Administration’s approval in the second half of the year, seeking to enter a market with no approved treatments in the country.

The drug, darovasertib, in combination ‌with ​Pfizer’s Xalkori, improved survival without progression of uveal ⁠melanoma by a median ⁠of 6.9 months, compared with 3.1 months for other chosen therapies.

The investigator-chosen therapies were either Merck’s Keytruda or a combination of Bristol Myers Squibb’s Opdivo and Yervoy, commonly used off-label ​to treat the disease.

In the 313-patient study, there were five complete responses, or disappearance of all detectable signs of cancer, ⁠in the darovasertib combination arm, compared ⁠with zero in the other arm.

Guggenheim analyst Paul ​Jeng said conversations with a physician suggest adoption of darovasertib will ​be “rapid and robust.”

Uveal melanoma is a rare, aggressive form ‌of eye cancer that usually spreads to other parts of the body, mainly the liver. Around 10,000 new cases are reported globally every year.

Around 20% of patients require enucleation, for which the ⁠eye is removed, while others may need radiation treatments that may cause permanent vision loss, Darrin Beaupre, IDEAYA’s medical chief, said.

The company has ⁠been able to “save ‌60% of eyes for patients who would otherwise ⁠require enucleation,” he said.

Between 50% and 70% ​of people ‌whose cancer has spread to other parts ​are of ⁠the HLA-A*02:01-negative serotype targeted by the drug, the companies said.

Immunocore’s Kimmtrak is the only therapy approved for the HLA-A*02:01-positive serotype, for which darovasertib is also being tested.

Truist’s Gregory Renza expects peak annual revenue of around $1.7 billion for darovasertib.

(Reporting by Puyaan Singh in Bengaluru; Editing ​by Sahal Muhammed)