What's Happening?
Zai Lab has released updated Phase 1 clinical trial data for zocilurtatug pelitecan, a DLL3-targeted antibody-drug conjugate (ADC) for small cell lung cancer (SCLC). The trial demonstrated robust and durable responses in heavily pre-treated patients,
with a 68% overall response rate in the 1.6 mg/kg dose cohort. The drug also showed promising activity in patients with brain metastases. Zai Lab is advancing to a global Phase 3 registrational study, aiming to further evaluate the safety and efficacy of the drug in a larger patient population.
Why It's Important?
The development of zocilurtatug pelitecan represents a significant advancement in the treatment of SCLC, a cancer with limited therapeutic options and poor prognosis. The promising Phase 1 results suggest that this drug could become a best-in-class treatment, offering new hope for patients who have exhausted other therapies. The initiation of a Phase 3 trial underscores the potential impact of this drug on the oncology landscape, particularly for patients with extensive-stage SCLC.
What's Next?
Zai Lab is set to begin a global Phase 3 trial, enrolling approximately 665 patients across North America, Asia, and Europe. This study will compare the efficacy of zocilurtatug pelitecan to existing therapies, with primary endpoints including overall response rate and overall survival. The company is also exploring the drug's potential in other neuroendocrine tumors, with plans to enter registrational phases for these indications in 2026.
