Ayala Pharmaceuticals Presents Positive Interim Data from Phase 2 ACCURACY Trial of AL101 for the treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma with Notch Activating Mutations at ESMO 2020
– Interim data showed meaningful clinical activity of AL101 4mg monotherapy with deep responses and 68% disease control rate
- Company to host virtual KOL event to review data today at 8:00am ET
REHOVOT, Israel and WILMINGTON, Del., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA) (Ayala or the Company), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced positive interim results from the ongoing Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch-activating mutations in a mini oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
“The study’s interim results are encouraging as we continue to study AL101 as a potential therapy for ACC patients with Notch-activating mutations. ACC is an orphan disease with no approved therapies and patients with Notch mutations have a more aggressive disease course and poorer survival outcomes as compared to patients with Notch wild-type,” said Renata Ferrarotto, M.D., Associate Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center and principal investigator in the study. “It’s promising to see meaningful clinical activity, including a significant disease control rate with a single agent in this patient population that represents a major unmet clinical need.”
“We are pleased to see promising progress from the Phase 2 ACCURACY clinical trial of AL101 as a potential monotherapy for ACC with a significant disease control rate in the 4mg arm of 68% from 40 evaluable patients, building upon the 61% disease control rate from 27 patients that we reported in 2019,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Within the context of this difficult to treat cancer, in which people living with ACC have become accustomed to historically low response rates and failed therapies, it’s exciting to see signs of advancement with both safety and efficacy. We remain on track with enrollment in the 6mg dose cohort arm and we look forward to providing further trial progress updates in the first half of 2021.”