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

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 17% higher in premarket trade.

IDEAYA will now submit an application for approval by the U.S. Food and Drug Administration 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 therapies chosen by the investigator, meeting the trial’s main goal.

The 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.

There were five complete responses, or disappearance of all detectable signs of cancer, observed in the darovasertib combination arm.

Uveal melanoma is a rare, aggressive form of eye cancer that usually spreads to other parts of the body, mainly the liver.

There are around 10,000 new cases of the disease globally every year, the companies 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, they said.

Truist analyst Gregory Renza said the brokerage expects $800 million in peak annual revenue for darovasertib to treat the disease.

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