Haichong Lin

Haichong Lin questioned the potential risk of an elongated overall survival (OS) for the control arm in Zoci's Phase 3 SCLC trial, given that tarlatamab is allowed both as a prior and post-progression treatment option. She also asked for detailed plans on deciding between doublet versus triplet regimens for Zoci in first-line SCLC after the Phase 1 trial data is shared in H2.

Answer

Rafael Amado, President and Head of Global Research and Development, clarified that patients in both arms of the Phase 3 SCLC study will be equally stratified for prior tarlatamab use and can only enter if they have progressed. He stated that post-progression therapies, including tarlatamab, cannot be controlled but are expected to be used equally across both arms, mitigating bias concerns. For first-line SCLC, Zai Lab aims to launch a Phase 2 study by year-end 2026, using landmark data on progression-free patients to decide between doublet and triplet regimens, with a strong desire to spare chemotherapy.

Lin Haichong raised concerns about Zoci's Phase III trial for second-line small cell lung cancer, specifically the potential for elongated overall survival (OS) in the control arm due to allowing tarlatamab as both prior and post-progression treatment. She also asked about the decision timeline for choosing between doublet and triplet regimens for Zoci in first-line SCLC.

Answer

President and Head of Global R&D Rafael Amado clarified that patients in both arms of the Phase III study will be equally post-tarlatamab (if applicable) and stratified, mitigating bias. Post-progression therapies, including tarlatamab, are uncontrolled but expected to be used equally across arms, thus not a concern for bias. For first-line SCLC, Zai Lab aims to launch a Phase II study by year-end, making a decision on doublet vs. triplet based on landmark progression-free survival data from the ongoing Phase I/II study, with a strong desire to spare chemotherapy.