Abstract 332P
Background
There is a high unmet need to improve the poor outcomes of 2L SCLC. BNT327 is an investigational bispecific antibody targeting PD-L1 and VEGF-A that has shown encouraging preliminary activity in combination with paclitaxel as 2L therapy for SCLC (ESMO 2023).
Methods
This ongoing multicenter, single-arm, phase II study conducted in China recruited patients (pts) with SCLC who progressed on chemotherapy (chemo) with or without PD-(L)1 inhibition (IOtreated or IO-naïve). Primary endpoints are safety (CTCAE v5.0) and ORR per RECIST v1.1. Pts received BNT327 (30 mg/kg Q3W) and paclitaxel (175 mg/m2 Q3W) for 5 cycles, followed by BNT327 maintenance until unacceptable toxicity or disease progression.
Results
As of 11 Jun 2024, 70 pts had been enrolled (26 IO-naïve, 44 IOtreated; 13 chemo-free interval
Conclusions
BNT327 shows clinical activity as 2L treatment in SCLC, with adverse events consistent with chemo and IO treatment. Further evaluation in 2L SCLC is ongoing in a global phase II and a phase III trial in China and with BNT324/DB-1311, a B7H3 ADC, in a phase I/II study.
Clinical trial identification
NCT05879068.
Editorial acknowledgement
Scientific writing assistance was provided by Claudia Gottstein and Andrew Finlayson, employees of BioNTech SE.
Legal entity responsible for the study
Biotheus Inc.
Funding
Biotheus Inc.
Disclosure
All authors have declared no conflicts of interest.