Ayala Pharmaceuticals presents updated AL102 results at ESMO congress

Ayala Pharmaceuticals announced that new data from the RINGSIDE study evaluating its lead investigational candidate AL102 for the treatment of desmoid tumors are being presented today at the European Society for Molecular Oncology, ESMO, Congress 2023, taking place October 20th to 24th in Madrid, Spain. RINGSIDE Study Phase 2 and OLE Highlights: The ongoing Phase 2/3 RINGSIDE clinical trial is a randomized, global multi-center study evaluating AL102 in patients with progressing desmoid tumors. The results presented at ESMO reflect a cut-off date as of July 5, 2023. Efficacy Results: 1.2 mg once daily achieved ORR of 83% per RECIST in the evaluable population as assessed by MRI BICR; ORR per RECIST was 64% in evaluable patients across the 3 dose arms; Efficacy results continue to demonstrate a dose-response pattern favoring the 1.2 mg once daily arm; First Partial Responses observed at 16 weeks and 21 additional PRs and 1 Complete Response across all dose arms; Early and deep volume and T2 signal intensity reductions within 16 weeks after starting 1.2 mg once daily; Best overall median reductions of 88% and 85% in volume and T2 signal intensity, respectively, in the 1.2 mg once daily arm at 16.6 months of median time on treatment; Reductions in volume and T2 signal intensity were also observed across biweekly dose arms; 29 patients rolled over to the OLE between Oct 2022 and May 2023, with 27 still on study; Three patients from the 4 mg BIW arm achieved PR after rolling over to the OLE where they received 1.2 mg once daily. Safety: AL102 was generally well tolerated with a manageable safety profile across all dose arms; Adverse events were consistent with gamma secretase inhibitors’ mechanism of action. The most frequent treatment-related AEs with 1.2 mg once daily included diarrhea, nausea, fatigue, dry skin, alopecia, stomatitis, dermatitis acneiform, dry mouth, hypophosphatemia, rash maculopapular and aspartate aminotransferase increased. There was one Grade 4 unrelated AE and no Grade 5 AEs. There were no treatment-related serious AEs