Ideaya Biosciences Stock Tumbles Despite Promising Data From Rare Eye Cancer Candidate

Ideaya Biosciences Inc. IDYA, a precision medicine oncology company, released interim Phase 2 clinical trial data.

The data centers on darovasertib in neoadjuvant (therapy before surgery) for uveal melanoma (UM) and an FDA Type C meeting on registrational trial design for regulatory approval in neoadjuvant UM. 

Uveal melanoma is the most common type of eye cancer in adults. Darovasertib is currently being evaluated in four ongoing clinical trials, two of which are in collaboration with Pfizer Inc PFE.

Also Read: IDEAYA Biosciences Highlights ‘Encouraging’ Preliminary Efficacy, Safety Profile For Patients With Hard-To-Treat Cancer.

The report shows:

• Approximately 49% of patients demonstrated greater than 30% tumor shrinkage and approximately 61% eye preservation rate for enucleation patients. 
• Darovasertib data show that approximately 49% of patients demonstrate greater than 30% tumor shrinkage and approximately 61% eye preservation rate for enucleation patients.
• Around 59% of patients showed greater than 20% ocular tumor shrinkage.

Ideaya is targeting to initiate a potential registration-enabling Phase 3 randomized clinical trial in neoadjuvant UM patients following finalization of the clinical protocol with the FDA. 

The randomized Phase 3 clinical trial design incorporates guidance and feedback from the U.S. FDA following a recent Type C meeting. 

In the Phase 3 clinical trial, the company projects that approximately 400 patients will be randomized to receive darovasertib in either the treatment arm or the control arm, with potential modifications pending further FDA feedback.

Price Action: Ideaya stock is down 5.3% at $33.14 per share at last check Monday.

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