Ascendis Pharma A/S ((ASND)) announced an update on their ongoing clinical study.
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Ascendis Pharma A/S recently provided an update on its clinical study titled BelieveIT-201: Phase 2, Randomized Open-labeled Trial of TransCon (TC) TLR7/8 Agonist in Combination With Pembrolizumab or With TC IL-2 β/γ, or Pembrolizumab Alone as Neoadjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma. The study aimed to assess the safety and efficacy of these treatments in patients with newly diagnosed advanced head and neck squamous cell carcinoma.
The study tested three interventions: TransCon TLR7/8 Agonist combined with pembrolizumab, TransCon TLR7/8 Agonist combined with TransCon IL-2 β/γ, and pembrolizumab alone. These treatments were intended to be administered prior to surgery to evaluate their effectiveness in reducing tumor size and improving surgical outcomes.
Designed as a Phase 2, randomized, open-label trial, the study involved a parallel intervention model with no masking. Its primary purpose was treatment-focused, aiming to compare the efficacy of the combination therapies against pembrolizumab monotherapy.
The study commenced on September 29, 2023, but was terminated before completion. The last update was submitted on July 31, 2025. These dates are crucial as they mark the study’s progress and its premature conclusion.
The termination of this study may impact Ascendis Pharma’s stock performance negatively, as investors often view halted trials as setbacks. Competitors in the oncology sector might gain a temporary advantage, affecting investor sentiment towards Ascendis Pharma.
Despite the study’s termination, further details and updates are available on the ClinicalTrials portal.