IDEAYA Closes Its Phase 3 Eye-Preservation Trial, Freeing Up $100-125 Million For Other Programs
The cancer drugmaker will lean on published Phase 2 data for guideline inclusion instead of a registrational trial of neoadjuvant darovasertib.
IDEAYA Biosciences, a precision medicine oncology company, has decided to stop enrollment and close its Phase 3 OptimUM-010 trial of neoadjuvant darovasertib in primary uveal melanoma, a rare eye cancer, according to its quarterly report filed Tuesday. The company blames ongoing site activation and enrollment challenges.
An assessment becomes a decision
The company's earnings release puts the estimated savings from closing the trial at $100-125 million, which it plans to reallocate to other pipeline programs, including potential registrational trials for IDE849 and IDE892.
The prior quarter's filing had said only that the company was assessing capital allocation given recruitment issues in the trial, and evaluating whether published data from the Phase 2 OptimUM-09 study could open a path to guideline inclusion. The new filing says IDEAYA plans to submit those published data to support inclusion in clinical practice guidelines. If that works, the company says, it may allow payor coverage for eligible US patients.
At the ESMO congress, the company presented follow-up data from about 119 OptimUM-09 patients. More than 85% saw robust tumor shrinkage, with a 57% eye preservation rate in the enucleation cohort, according to the release.
Spending keeps climbing
The savings offset only part of a rising bill. Research and development spending for the nine months reached $325.991 million, against $228.105 million a year earlier, and the company says it expects R&D to increase substantially over the next few years.
The net loss for the nine months was $336.7 million, versus $30.4 million a year earlier, when upfront license revenue from Servier lifted results. Cash and marketable securities stood at about $1.15 billion on September 30, and the company said its runway guidance into 2030 is unchanged.
IDEAYA has no approved products. Darovasertib is its lead drug, and it completed its new drug application for the metastatic indication in the third quarter. Under its Servier license for markets outside the US, $139.8 million of remaining performance obligations tied to clinical cost reimbursements will be recognized as revenue as the work is completed.
Next stops: London and year-end
IDEAYA holds an R&D Day in London on November 16, where it plans to present new preclinical data. It also plans to start two Phase 3 registrational trials of IDE849 in small cell lung cancer and neuroendocrine carcinomas by year end.
IDEAYA's market value was $3.1 billion as of Tuesday's report, and the November 16 R&D Day is the next scheduled update.
