The company faces ongoing legal disputes and contractual disagreements, with approximately EUR600 million accrued year-to-date for these issues.
Q: Can you discuss the upcoming data for BNT323 in endometrial cancer and what would be considered positive data? A: We expect to share efficacy and safety data from our single-arm trial in second-line endometrial cancer in 2025. Positive data would include a strong clinical activity profile and favorable safety across different HER2 expression levels. - Oezlem Tuereci, Chief Medical Officer
Q: How does BNT327 compare to similar bispecifics in terms of outcomes and differentiation? A: BNT327 targets PD-L1, potentially enriching its activity in the tumor microenvironment. While early data shows similar outcomes to other bispecifics, we are exploring if this mechanistic difference could lead to better response rates and durability, especially in PD-L1 positive tumors. - Ugur Sahin, Chief Executive Officer
Q: What is the rationale for pursuing BNT327 in a biomarker-selected population for first-line NSCLC? A: BNT327 has shown clinical activity in both PD-L1 positive and negative populations. We aim to overcome the limitations of checkpoint blockade in PD-L1 negative tumors, and our trial will stratify patients by PD-L1 positivity. - Ugur Sahin, Chief Executive Officer
Q: Can you clarify the provision amount for contractual disputes and its relation to ongoing patent disputes? A: We have accrued approximately EUR600 million year-to-date for contractual disputes with licenses and collaborators. Due to legal constraints, we cannot specify details, but it involves multiple disputes. - Jens Holstein, Chief Financial Officer
Q: What are the survival benchmarks for the upcoming BNT327-TNBC data, and is interim data expected from the global Phase II lung cancer trial next year? A: The trial is powered for PFS and OS, with benchmarks in the range of four to five months for PFS. We plan to provide updates at the 15 and 18-month OS mark, comparing to benchmarks like pembrolizumab's 15 to 23-month median OS. - Ugur Sahin, Chief Executive Officer
For the complete transcript of the earnings call, please refer to the full earnings call transcript.