On March 3, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported that the Independent Data Monitoring Committee (IDMC) for its Phase 2/3 RINGSIDE study evaluating investigational new drug AL102 in desmoid tumors conducted a prespecified periodic review of data from the study and recommended that the study continue without modifications (Press release, Ayala Pharmaceuticals, MAR 3, 2023, View Source [SID1234628135]).
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"We thank the IDMC members for their work and guidance and are pleased with their recommendation to continue RINGSIDE with no changes," said Ken Berlin, President and CEO of Ayala. "This recommendation was made based on the analysis of recently updated data from the Phase 2 segment of RINGSIDE. We have commenced enrollment in the Phase 3 segment of RINGSIDE on a worldwide basis. In addition, patients from Phase 2 have the opportunity to continue treatment in the open label extension in Phase 3. We believe that once-daily AL102 has best-in-class potential and are excited about its potential use in desmoid tumors. If approved, we believe it will be a valuable addition to the future therapeutic armamentarium in this underserved indication."
Andres Gutierrez, M.D. Ph.D., EVP and Chief Medical Officer of Ayala, stated, "The IDMC is looking forward to reviewing the long term-safety profile of AL102 from the open label extension of Phase 2 and has also agreed to the proposed plans for analysis and reporting of results in the ongoing Phase 3 segment of the study. We plan to present these recently updated data from the Phase 2 segment of RINGSIDE at an upcoming medical meeting in 2023."
Phase 3 of RINGSIDE is a double-blind, placebo-controlled, clinical trial enrolling up to 156 patients with progressive disease, comparing AL102 at 1.2 mg once-daily to placebo. The primary endpoint for Phase 3 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 of 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, or other 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 surgical morbidity and a high rate of recurrence post-surgery. There are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.