New Delhi: A new experimental therapy developed in China has shown encouraging early results in treating relapsed small-cell lung cancer (SCLC), one of the most aggressive and difficult-to-treat forms of cancer.
Why It Matters
SCLC represents about 10–12% of all lung cancer cases worldwide and is known for its rapid progression and limited treatment options. According to the International Agency for Research on Cancer, more than 2.4 million people were diagnosed with lung cancer in 2022.
About The Drug
The investigational treatment, called SHR-4849 (IDE849), is a Delta-like ligand 3 (DLL3)-targeted antibody-drug conjugate (ADC). It combines a humanized anti-DLL3 antibody with a DNA topoisomerase I inhibitor, allowing it to selectively attack tumor cells with high DLL3 expression.
Trial Results
Researchers at the Affiliated Cancer Hospital of Shandong First Medical University tested SHR-4849 in a Phase I trial involving 54 patients with relapsed SCLC.
- 42 patients were evaluable for response.
- Objective Response Rate (ORR): 59.5%
- Disease Control Rate (DCR): 90.5%
- For patients monitored for at least 12 weeks, ORR rose to 69.2% overall, and 77.8% at the 2.4 mg/kg expansion dose.
Safety Profile
The main side effects reported were lowered white blood cell counts, anemia, neutropenia, and nausea. Importantly, no dose-limiting toxicities or treatment-related deaths occurred. Researchers also observed low plasma exposure of the free toxin, indicating a potentially safer profile than comparable therapies.
Next Steps
Lead investigator Dr. Linlin Wang, presenting at the 2025 World Conference on Lung Cancer (IASLC), said:
“This is the first-in-human study of SHR-4849, and the encouraging early data support further investigation of this drug as a potential treatment for patients with DLL3-positive relapsed SCLC.”
Dose expansion studies are now underway to determine the recommended Phase II dose, with hopes that SHR-4849 could become a much-needed targeted therapy for SCLC patients.
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