There is uncertainty regarding the HexaBody CD38 program, with data release contingent on J&J's opt-in decision, which could impact future strategic planning.
Q: Can you clarify when the top line data for HexaBody CD38 will be disclosed? A: The top line data for HexaBody CD38 will be announced once J&J has made the opt-in decision, not at the date of submission. This ensures the integrity of J&J's review process. - Jan Van De Winkel, CEO
Q: Why is there no FR alpha expression requirement in the Phase 3 trial for Rina-S? A: The decision not to preselect for folate receptor alpha expression was based on data showing activity regardless of expression levels. We observed activity even in patients with folate-receptor expression below 25%. - Judith Klimovsky, Chief Development Officer
Q: What factors led to the decision to discontinue the planned Phase 3 for Tivdak? A: The decision was strategic, based on pipeline prioritization and the totality of data, both external and internal. It was not due to any specific data issue but rather a focus on other priorities. - Judith Klimovsky, Chief Development Officer
Q: What are the expectations for EPKINLY's commercial traction and potential major drivers? A: EPKINLY is expected to expand from third-line plus DLBCL to potential new approvals in FL, especially in the US and Japan. The focus will be on earlier lines of therapy and combinations to increase value. - Brad Bailey, Chief Commercial Officer
Q: Are there any updates on the pipeline review and potential further deprioritization? A: We have reprioritized our pipeline, stopping progression of certain programs that didn't meet our high bar for differentiation. Future pipeline adjustments will be based on data, focusing on promising candidates. - Jan Van De Winkel, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.