What's Happening?
Zai Lab has announced updated data from its Phase 1 clinical trial of zocilurtatug pelitecan, a DLL3-targeted antibody-drug conjugate (ADC) for small cell lung cancer (SCLC). The trial demonstrated robust
responses in heavily pre-treated patients, with a 68% overall response rate in the 1.6 mg/kg dose group. The drug also showed promising results in patients with brain metastases, achieving an 80% response rate in those without prior brain radiotherapy. The safety profile was favorable, with low rates of severe treatment-related adverse events. Zai Lab is now initiating a global Phase 3 trial to further evaluate the drug's efficacy and safety.
Why It's Important?
The development of zocilurtatug pelitecan is significant as it addresses the high unmet need for effective treatments in extensive-stage small cell lung cancer, a particularly aggressive form of cancer with limited options. The promising results from the Phase 1 trial suggest that this drug could become a best-in-class treatment, potentially improving outcomes for patients who have exhausted other therapies. The initiation of a Phase 3 trial marks a critical step towards regulatory approval and commercialization, which could have a substantial impact on the oncology market and patient care.
What's Next?
Zai Lab plans to enroll approximately 665 patients globally in the Phase 3 trial, which will compare zocilurtatug pelitecan to standard therapies. The trial will assess overall response rates and survival outcomes, with results expected to inform future regulatory submissions. The company is also expanding the drug's development into first-line SCLC and neuroendocrine carcinoma, with registrational studies planned for 2026. These efforts could lead to broader applications of the drug and further advancements in cancer treatment.
