#United States #IDEAYA Biosciences #South San Francisco #Trodelvy #IDE397

IDEAYA Biosciences Reports Encouraging Outcomes from Innovative Cancer Trial

On September 8, 2025, IDEAYA Biosciences, a prominent precision medicine oncology firm, shared groundbreaking findings from their Phase 1/2 clinical trial combining IDE397 with Trodelvy® for patients suffering from late-stage methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer. This approach targets a patient demographic facing a dire need for effective therapies, given the scarcity of FDA-approved options for those with MTAP-deletion solid tumors.

Trial Overview and Results

The combination of 30 mg IDE397 and 7.5 mg/kg Trodelvy demonstrated a notable overall response rate (ORR) of 57%, with four out of seven participants achieving meaningful clinical responses. In contrast, a lower dose of 15 mg IDE397 in conjunction with 10 mg/kg Trodelvy reflected an ORR of 33%.

With the trial comprising a total of 19 patients, data up until August 29, 2025, indicated that 68% of these participants experienced tumor progression following two or more previous treatments, while a significant 84% had undergone immune-oncology therapies. This underscores the trial's critical focus on a particularly challenging patient group who have exhausted existing treatment options.

Safety Profile and Future Directions

Despite the complexity of administering combination therapies, the safety profile observed in both dosing cohorts was manageable and consistent with the known adverse effects of each treatment. No serious adverse events were reported for the subjects receiving the higher dosage of IDE397 and Trodelvy at their respective expansion doses, an encouraging sign for further exploration.

The next steps include selecting a recommended Phase 2 dose, expected by the end of 2025, with plans to present further updates during medical conferences scheduled for early 2026. This testing will not only apply to the MTAP-deletion urothelial cancer cohort but will also extend to non-small cell lung cancer (NSCLC), with the first patient already dosed in related trials.

A Positive Outlook for Cancer Treatment

Darrin Beaupre, Chief Medical Officer at IDEAYA, expressed optimism regarding the data, emphasizing, “We are pleased with the progress we are making with the Trodelvy and IDE397 combination and are encouraged by the early response rate data we are seeing in previously treated MTAP-deleted urothelial cancer.” Such enthusiasm reflects a broader hope that innovative combinations like these could change the narrative for patients in desperate need of effective cancer therapies.

The historical context provides additional optimism, as earlier monotherapy responses to Trodelvy were reported at a stark 11% ORR in previously treated patients and 23% in those naive to enfortumab vedotin therapy, highlighting the potential of combining IDE397 with Trodelvy in providing improved treatment outcomes.

IDEAYA continues to uphold a commitment to precision oncology through innovative research and development, with a robust pipeline focused on synthetic lethality and antibody-drug conjugates for various molecularly defined solid tumor indications.

Conclusion

As this collaboration between IDEAYA and Gilead unfolds, the broader oncology community watches with bated breath, hoping for solutions to the pressing challenges posed by MTAP-deletion cancers. The company remains vigilant in advancing its mission to deliver transformative therapies that can thoughtfully address the unique genetic drivers of cancer, thereby aiming to enhance clinical results for patients worldwide. IDEAYA will deliver a comprehensive review of these findings at their 10-Year Anniversary RD Day in New York, ensuring that this pivotal moment in cancer research receives the attention it merits.

For real-time updates and further insights, stay tuned to IDEAYA's corporate communications and participate in the ongoing conversation around these landmark advancements in cancer therapy.