On September 29, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers, reported that it will host a key opinion leader (KOL) webinar on unmet medical needs and evolving treatment landscape of desmoid tumors on Thursday, October 6, 2022, at 8:00 am ET (Press release, Ayala Pharmaceuticals, SEP 29, 2022, View Source [SID1234621559]).
The webinar will include presentations by Professors Bernd Kasper, MD, Ph.D., from the Mannheim University Medical Center, and Robin Jones, MD, from The Royal Marsden Hospital and Institute of Cancer Research. Prof. Kasper will discuss the current treatment landscape for desmoid tumors and Prof. Jones will review the positive data from Part A of the ongoing Phase 2/3 RINGSIDE trial of AL102 that were presented at ESMO (Free ESMO Whitepaper) 2022.
Ayala management will provide a company update. A live Q&A session will follow the formal presentations. To register for the event, please click here.
Professor Robin Jones is Head of the Sarcoma Unit at The Royal Marsden Hospital and Team Leader in Sarcoma Clinical Trials at The Institute of Cancer Research. Professor Jones received his medical training at Guy’s and St Thomas’ Hospital and his oncology training at The Royal Marsden. Between 2010 and 2014 he was Head of the Sarcoma Program at the University of Washington/Fred Hutchinson Cancer Research Center in Seattle. His research focuses on developing novel therapies for soft tissue sarcomas and he is currently working on a number of trials of investigational agents as well as laboratory-based studies.
Professor Bernd Kasper is Chair of the Mannheim Cancer Center (MCC) at the Mannheim University Medical Center. Professor Kasper received his MD from Heidelberg University in 2000 and also studied at the Imperial College School of Medicine, Jules Bordet Institute in Brussels, and in South Kerala, India. He has a lifetime professional dedication to patient care and research in soft tissue sarcomas, desmoid-type fibromatosis, and gastrointestinal stromal tumors and is the Principal Investigator of several national and international trials.
AL102 is being evaluated in the ongoing RINGSIDE pivotal Phase 2/3 clinical trial in desmoid tumors. Positive interim results from Part A, the Phase 2 segment of this study, were presented at ESMO (Free ESMO Whitepaper) 2022, showing efficacy across all cohorts, with early tumor responses that deepened over time. AL102 was well tolerated, which could allow for long term treatment of patients. The company has initiated Part B of RINGSIDE (Phase 3), as well as enrolling patients in an open label extension study.
About the RINGSIDE study
The RINGSIDE pivotal Phase 2/3 study is a randomized global multi-center trial. Part A of the study is evaluating the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in patients with desmoid tumors. It enrolled 42 patients and is evaluating 3 doses of AL102. Patients who participated in Part A are eligible to enroll into an open-label extension study at the Part B selected dose of 1.2 mg daily, and long-term efficacy and safety will be monitored.
Part B of the study, the Phase 3 segment, has been initiated. This is a double-blind, placebo-controlled segment enrolling up to 156 patients with progressive disease, comparing AL102 at 1.2 mg once daily to placebo. The primary endpoint for Part B is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), tumor volume reduction, and patient-reported Quality of Life (QOL) measures. For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).
About Desmoid Tumors
Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to a high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.