Amgen Inc. and Zai Lab Limited announced a global Phase 1b clinical‑trial collaboration to evaluate Zai Lab’s investigational DLL3‑targeting antibody‑drug conjugate, zocilurtatug pelitecan, in combination with Amgen’s IMDELLTRA bispecific T‑cell engager in patients with extensive‑stage small cell lung cancer.
The study will assess the safety and efficacy of the dual‑targeting approach, which couples the potent cytotoxic payload of the ADC with the immune‑mediating activity of the BiTE. The combination is designed to increase response rates and depth of response, including intracranial activity, by simultaneously delivering a direct tumor‑cell kill and activating T‑cells against DLL3‑expressing cells.
Strategically, the partnership expands Amgen’s oncology pipeline into a high‑need indication and leverages Zai Lab’s DLL3‑ADC platform, while Zai Lab gains access to Amgen’s proven BiTE technology. The collaboration is positioned to accelerate development of a potentially transformative therapy for a disease with limited options after platinum‑based chemotherapy.
Investors reacted positively to the announcement, reflecting confidence in the dual‑targeting strategy and the potential for a new treatment paradigm in extensive‑stage small cell lung cancer.
"In combination, this dual‑targeting strategy has the potential to increase the rate and deepen responses both systemically and, in the brain, address resistance pathways, and unlock new treatment paradigms for patients with small cell lung cancer," said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. "These two approaches leverage complementary mechanisms — our ADC delivers a potent cytotoxic payload directly to DLL3‑expressing tumor cells, while the T‑cell engager is designed to activate T‑cells by binding the same antigen and eliciting an immune response against the tumor."
"The FDA's decision reinforces IMDELLTRA as a recognized standard of care for people living with extensive stage small cell lung cancer whose disease progressed on or after frontline therapy. We are committed to delivering transformative medicines for patients facing challenging cancers, and we are currently focused on rapidly developing IMDELLTRA in earlier stages of disease and earlier lines of therapy for small cell lung cancer patients," said Jay Bradner, M.D., Executive Vice President of Research and Development at Amgen.
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