IDEAYA reports promising results in urothelial cancer treatment trial

SOUTH SAN FRANCISCO - IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a clinical-stage biotech company with a market capitalization of $2.38 billion and strong financial health according to InvestingPro data, today announced initial data from its Phase 1/2 trial combining IDE397, a MAT2A inhibitor, with Gilead’s Trodelvy in patients with MTAP-deletion urothelial cancer.

The trial showed an overall response rate of 57% in patients treated with 30 mg IDE397 plus 7.5mg/kg Trodelvy, and 33% at the lower dose combination. All responses at the higher dose included three confirmed partial responses and one unconfirmed partial response. The positive trial results have contributed to IDEAYA’s strong recent performance, with the stock showing a 10.63% return over the past week. Analysts maintain a bullish stance on the company, with price targets ranging from $25 to $74 per share.

The combination demonstrated a manageable safety profile consistent with the known adverse events of both drugs as single agents. No treatment-related serious adverse events were observed at the higher dose level. The most common Grade 3 or greater treatment-related adverse events included anemia, neutropenia, asthenia, and diarrhea.

MTAP-deletion occurs in approximately 25-30% of urothelial cancer patients and currently has no FDA-approved targeted therapies. The preliminary data appears to trend favorably compared to historical Trodelvy monotherapy efficacy in metastatic urothelial cancer.

"We are encouraged by the early response rate data we are seeing in previously treated MTAP-deleted urothelial cancer," said Darrin Beaupre, Chief Medical Officer at IDEAYA Biosciences, according to the press release.

The company plans to select a recommended Phase 2 dose by the end of 2025, with the next update scheduled for a medical conference in the first half of 2026. IDEAYA has also begun dosing the first patient in a trial testing the combination in non-small cell lung cancer.

Under their collaboration agreement, IDEAYA and Gilead retain commercial rights to their respective compounds. IDEAYA is the study sponsor while Gilead provides Trodelvy supply. The company maintains a healthy financial position with a current ratio of 12.39 and more cash than debt on its balance sheet. InvestingPro subscribers can access 13 additional key insights and a comprehensive analysis of IDEAYA’s financial health and growth prospects through the Pro Research Report.

The use of Trodelvy in MTAP-deletion urothelial cancer remains investigational, and the safety and efficacy of this combination have not been established by regulatory agencies. With analysts forecasting 114% revenue growth for the current fiscal year, investors can track IDEAYA’s progress and access detailed financial analysis through InvestingPro’s comprehensive research tools and real-time updates.

In other recent news, Ideaya Biosciences announced positive interim results from its Phase 2 OptimUM-09 trial for its eye cancer treatment, darovasertib. The trial showed significant tumor shrinkage in primary uveal melanoma patients, with 76% achieving at least a 20% reduction in ocular tumor size. Additionally, 48% of patients experienced a reduction in simulated radiation dose to key visual structures, indicating potential vision improvements. In collaboration with Hengrui Pharma, Ideaya also reported promising data from a Phase 1 trial of their lung cancer drug, IDE849, which demonstrated a 77.1% overall response rate in small cell lung cancer patients. The drug’s performance was highlighted at the World Conference on Lung Cancer in Barcelona. Citizens JMP subsequently raised its price target for Ideaya Biosciences to $45, citing strong clinical data from the IDE849 trial. Furthermore, Ideaya has enrolled its first non-small cell lung cancer patient in a new trial combining its MAT2a inhibitor IDE397 with Gilead’s Trodelvy. This trial expansion follows previous plans to broaden the study’s focus beyond urothelial cancer.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.