Promising Phase 1 Results for IDE849 in Lung Cancer at IASLC 2025

Promising Phase 1 Results for IDE849 in Lung Cancer

At the IASLC 2025 World Conference on Lung Cancer held in Barcelona, IDEAYA Biosciences, Inc. and Hengrui Pharma revealed groundbreaking Phase 1 trial data for IDE849 (SHR-4849), a novel antibody-drug conjugate targeting DLL3. This emerging therapeutic candidate seeks to establish its place as a first-in-class option in the treatment of small cell lung cancer (SCLC).

Key Findings from the Presentation

The trial comprised a diverse group of 100 patients receiving doses between 0.8 mg/kg to 4.2 mg/kg of IDE849, administered on a once every three-week basis. Notably, the trial showcased an overall response rate (ORR) of 80% in those receiving the 2.4 mg/kg dose among previously treated SCLC patients. Furthermore, a confirmed ORR of 70% was documented, indicating a strong initial efficacy profile. Across all dosages, IDE849 demonstrated a compelling 73.7% ORR in SCLC patients, with 57.9% achieving confirmed ORR, showcasing the drug’s potential effectiveness in challenging cases.

The presentation highlighted that among patients with baseline brain metastases, the confirmed ORR stood out at 83.3% at the 2.4 mg/kg dosage, reinforcing IDE849's potential even in advanced-stage patients. The median progression-free survival (PFS) was reported as 6.7 months across various treatment lines, although it remains not yet reached in 2L SCLC patients, emphasizing the need for further investigation into its long-term efficacy.

Safety profiles appeared manageable, with Grade 3 or higher treatment-related adverse events reported in 48% of patients, predominantly manifesting as common hematological side effects such as neutropenia and anemia. Importantly, there were no treatment-related deaths, and only 2% of patients discontinued treatment due to adverse effects, signaling a favorable benefit-risk ratio for IDE849.

The Future of IDE849 and Cancer Treatment

Yujiro S. Hata, President and CEO of IDEAYA Biosciences, articulated enthusiasm regarding the trial results, suggesting they present IDE849 as not only a potential first-in-class treatment but also one of the best-in-class options for addressing unmet medical needs in cancer therapy. The ongoing collaboration between IDEAYA and Hengrui Pharma aims to propel the global development of IDE849 across various indications, including SCLC and neuroendocrine tumors, as well as its investigation for additional DLL3 upregulated solid tumors.

Following up on this momentum, IDEAYA is scheduled to review further data as presented by Hengrui during its 10-Year Anniversary RD Day event. This ongoing exchange of findings between the two companies promises to accelerate IDE849’s clinical development, benefitting patients around the globe.

The licensing agreement struck between Hengrui Pharma and IDEAYA in December 2024 grants IDEAYA exclusive rights to further develop and commercialize SHR-4849 outside Greater China, an important step toward making innovative cancer therapies accessible to a worldwide patient population.

About IDEAYA Biosciences

IDEAYA Biosciences is dedicated to oncology precision medicine and focuses on discovering effective therapeutic options through a unique combination of small-molecule drug development and bioinformatics. They strive to reveal promising treatment avenues tailored to the genetic profiles of cancer patients, thereby enhancing clinical outcomes and addressing the substantial challenges posed by oncological diseases. The presentation at IASLC illustrates IDEAYA's commitment to innovation and patient care, setting the stage for future advancements in cancer treatment.

In conclusion, the promising early data for IDE849 presented at this year’s World Conference on Lung Cancer undoubtedly highlights a ray of hope for patients grappling with SCLC, marking a significant milestone in the search for effective cancer therapies.