Prodotti competitors / Area Oncology
BioNTech presents Phase 2 results of trastuzumab pamirtecan in HER2‑expressing advanced endometrial cancer at SGO 2026
On April 11, 2026, BioNTech presented positive Phase 2 data from the NCT05150691 study evaluating trastuzumab pamirtecan (T‑pam; BNT323/DB‑1303), a HER2‑targeted antibody–drug conjugate (ADC), in patients with HER2‑expressing advanced endometrial cancer whose disease had progressed on or after first‑line therapy. The results were delivered as an oral abstract presentation at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting.
In the Phase 2 cohort (N=96) of patients treated with T‑pam monotherapy in the second line or later setting, the confirmed objective response rate (ORR) was 47.9% (95% CI: 37.6–58.4). Median duration of response (mDOR) was 11.1 months (95% CI: 9.0–18.3), and median progression‑free survival (mPFS) was 8.1 months (95% CI: 5.1–11.8). Antitumor activity was observed across different levels of HER2 expression.
The presentation also reported outcomes in a subgroup of patients with HER2 IHC 1+ endometrial cancer (n=29), showing a confirmed ORR of 34.5% (95% CI: 17.9–54.3), suggesting potential clinical activity of HER2‑directed ADCs beyond tumors with high HER2 expression.
Regarding safety, grade ≥3 treatment‑related adverse events (TRAEs) occurred in 46.9% of treated patients, with anemia and platelet count decrease being the most frequently reported severe events. Any‑grade pneumonitis was observed in 21.4% of patients, including adjudicated cases of grade ≥3 interstitial lung disease (ILD)/pneumonitis, which led to protocol amendments introducing enhanced monitoring and mitigation measures.
Trastuzumab pamirtecan received FDA Fast Track and Breakthrough Therapy designations for the treatment of endometrial cancer in 2023. The agent is currently being evaluated in a global Phase 3 confirmatory study, FERN‑EC‑01 (NCT06340568), in patients with advanced or recurrent HER2‑positive endometrial cancer treated in the second line or later. Based on the Phase 2 findings, BioNTech has indicated a potential accelerated regulatory pathway in the United States.
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