MAINZ, Germany, May 22, 2026
BioNTech announced new clinical data presentations and pipeline updates from its expanding late-stage oncology portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The company will showcase progress across multiple Phase 2 and Phase 3 oncology programs, including key updates for investigational immunotherapy candidates pumitamig and gotistobart, alongside ongoing pivotal studies involving antibody-drug conjugates (ADCs) and novel cancer treatment combinations. BioNTech stated that the presentations reinforce its strategy of building a diversified oncology pipeline targeting multiple tumor types with high unmet medical need.
Pumitamig Shows Encouraging Lung Cancer Activity
BioNTech will present updated data from the ongoing Phase 2/3 ROSETTA Lung-02 trial evaluating pumitamig (BNT327/BMS986545) combined with chemotherapy in first-line non-small cell lung cancer (NSCLC). Pumitamig is an investigational bispecific immunomodulator designed to target both PD-L1 and VEGF-A pathways simultaneously and is being developed in collaboration with Bristol Myers Squibb. Interim trial results demonstrated encouraging anti-tumor activity across squamous and non-squamous NSCLC patients regardless of PD-L1 expression levels. According to BioNTech, these findings represent the third global dataset showing consistent activity for pumitamig plus chemotherapy following earlier studies in small cell lung cancer and triple-negative breast cancer.
Gotistobart Delivers Positive Ovarian Cancer Survival Data
The company will also present Phase 2 overall survival data from the PRESERVE-004 study evaluating gotistobart (BNT316/ONC-392) combined with pembrolizumab in heavily pretreated patients with platinum-resistant ovarian cancer. BioNTech reported that the investigational CTLA-4-targeting immunotherapy demonstrated durable anti-tumor activity and clinically meaningful survival outcomes with a manageable safety profile. The results further support gotistobart’s potential as a chemotherapy-free treatment option for difficult-to-treat ovarian cancer patients while strengthening the company’s immuno-oncology strategy focused on tumor microenvironment modulation.
Advertisement
BioNTech Expands ADC and Combination Oncology Programs
BioNTech also highlighted continued expansion of its oncology pipeline, which now includes more than 25 Phase 2 and Phase 3 studies and 13 ongoing pivotal trials. Additional ASCO presentations will feature investigational ADC candidates including BNT326/YL202, BNT324/DB-1311, and trastuzumab pamirtecan (BNT323/DB-1303) across solid tumors, prostate cancer, and endometrial cancer. The company emphasized that its long-term strategy focuses on combining immunotherapies, ADCs, and mRNA-based cancer technologies to develop differentiated oncology treatments capable of addressing major gaps in cancer care globally.
Source: BioNTech, press release
