BioNTech SE and partner DualityBio announced that the primary objective of a Phase 2 cohort of trastuzumab pamirtecan (BNT323/DB‑1303) in HER2‑expressing, advanced endometrial cancer was met. The 145‑patient cohort included individuals whose disease progressed after first‑line chemotherapy, with or without prior checkpoint‑inhibitor therapy. The confirmed objective response rate (ORR) was 47.9% among centrally tested patients and 49.3% in the subset that had received checkpoint inhibitors, while median progression‑free survival was 8.1 months and median duration of response was 10.3 months.
The safety profile was manageable, with grade ≥ 3 treatment‑related adverse events reported in 46.9% of patients and grade ≥ 3 interstitial lung disease or pneumonitis in 4.8%. These data reinforce the drug’s potential to address an unmet need in patients who have progressed on immunotherapy.
The results support BioNTech’s strategy to advance BNT323 toward regulatory approval. The company and DualityBio plan to file a biologics license application in 2026 and are conducting a global confirmatory Phase 3 trial (Fern‑EC‑01). Findings will be presented at the 2026 Society of Gynecologic Oncology annual meeting in San Juan, Puerto Rico, scheduled for April 10‑13.
BioNTech’s broader oncology pipeline, which includes more than 25 candidates, underpins its goal of becoming a multi‑product company by 2030. In FY 2025 the company spent €2.10 billion on R&D, held €17.2 billion in cash and securities, and reported a net loss of €1.14 billion. Guidance for FY 2026 revenue of €2.0‑2.3 billion reflects a shift away from COVID‑19 vaccine sales but signals confidence in the expanding oncology portfolio.
The trial’s success comes amid a competitive landscape where checkpoint inhibitors dominate first‑line therapy and newer HER2‑targeted ADCs, such as trastuzumab deruxtecan, are emerging. Trastuzumab pamirtecan’s third‑generation ADC design delivers a topoisomerase‑1 inhibitor payload directly to HER2‑expressing cells, enabling activity even at low HER2 expression levels and offering a therapeutic option for patients who have progressed on immunotherapy.
"These positive results in patients with endometrial cancer including those with lower HER2 expression levels support the potential of trastuzumab pamirtecan," said Prof. Özlem Türeci, M.D., Co‑Founder and Chief Medical Officer at BioNTech.
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