BioNTech Showcases Pumitamig Lung Cancer Activity and Gotistobart Survival Gain
Interim data from the Phase 2 ROSETTA Lung-02 trial demonstrated pumitamig plus chemotherapy eliciting anti-tumor activity in first-line non-small cell lung cancer. Gotistobart with pembrolizumab achieved durable responses and improved overall survival in platinum-resistant ovarian cancer, underpinning BioNTech’s 25+ Phase 2/3 trials, including 13 pivotal studies.
1. Pumitamig Phase 2 ROSETTA Lung-02 Trial
Interim analysis of the Phase 2 ROSETTA Lung-02 trial showed that pumitamig combined with chemotherapy produced consistent anti-tumor responses in first-line non-small cell lung cancer patients across PD-L1 expression levels and histologies, informing the design of the ongoing pivotal Phase 3 comparison against pembrolizumab plus chemotherapy.
2. Gotistobart Phase 2 Overall Survival Data
Results from the Phase 2 PRESERVE-004 trial indicated that gotistobart plus pembrolizumab delivered durable responses and clinically meaningful overall survival benefits in heavily pre-treated platinum-resistant ovarian cancer patients, supported by a manageable safety profile.
3. Late-Stage Pipeline Expansion
BioNTech’s late-stage oncology portfolio now includes over 25 Phase 2 and Phase 3 clinical trials, among them 13 ongoing pivotal studies and novel-novel combination programs such as ADC-based regimens across major tumor types, with data presentations scheduled for May 29–June 2 at the ASCO Annual Meeting.