BioNTech SE(US:BNTX) Globenewswire·2025-09-08 15:00Core Insights - BioNTech and Bristol Myers Squibb presented interim data from a Phase 2 trial of pumitamig, a bispecific antibody targeting PD-L1 x VEGF-A, showing promising anti-tumor responses in extensive-stage small cell lung cancer patients [1][4][5] Group 1: Clinical Trial Results - The interim analysis included 43 patients with untreated extensive-stage small cell lung cancer, revealing a confirmed overall response rate of 76.3% and a disease control rate of 100% [2][4] - Median progression-free survival was reported at 6.8 months, with early tumor shrinkage observed in 89.5% of patients [2][4] - The safety profile of pumitamig plus chemotherapy was manageable, with a discontinuation rate of 14% and no new safety signals beyond those typically associated with chemotherapy [2][4] Group 2: Future Research and Development - A global Phase 3 trial, ROSETTA-LUNG-01, is ongoing to evaluate pumitamig plus chemotherapy against atezolizumab plus chemotherapy as a first-line treatment for extensive-stage small cell lung cancer [5][10] - Pumitamig has received Orphan Drug designation from the FDA for small cell lung cancer treatment in 2025, indicating its potential significance in addressing this aggressive cancer type [5][10] Group 3: Industry Context - Small cell lung cancer accounts for 15% of all lung cancer cases, with a poor prognosis and a 5-year survival rate of only 5% in advanced stages, highlighting the urgent need for new treatment options [2][8] - The combination of PD-L1 checkpoint inhibition and VEGF-A neutralization in pumitamig aims to enhance therapeutic precision and minimize systemic exposure, addressing significant treatment challenges in oncology [9][10]