ADXS - Ayala Pharmaceuticals Presents Updated AL102 Results from Phase 2 Clinical Trial in Desmoid Tumors at ESMO Congress 2023 | Benzinga

AL102 1.2 mg once daily treatment achieved Overall Response Rate of 83% in the evaluable population  

AL102 1.2 mg once daily treatment resulted in 88% reduction in tumor volume and 85% reduction in T2W signal intensity

REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX:ADXS), a clinical-stage oncology company, today announced that new data from the RINGSIDE study evaluating its lead investigational candidate AL102 for the treatment of desmoid tumors (DT) are being presented today at the European Society for Molecular Oncology (ESMO) Congress 2023, taking place October 20^th to 24^th in Madrid, Spain. The data are from Phase 2 (Part A) of the study and from the Open Label Extension (OLE). The results are featured in a poster being presented by Professor Robin Jones, Team Leader in Sarcoma Clinical Trials at The Institute of Cancer Research and Consultant Medical Oncologist at The Royal Marsden, UK.

"The RINGSIDE results continue to improve over time, with more patients in this latest Phase 2 and OLE data cut demonstrating responses to treatment with AL102," said Kenneth Berlin, President and CEO of Ayala. "We are seeing impressive anti-tumor activity across multiple parameters and are particularly encouraged by the high response rates, including 83% in the 1.2 mg once daily arm, the dose being used in our Phase 3 study, and 64% across all three doses combined. Furthermore, in two other important efficacy parameters, patients receiving 1.2 mg daily dose experienced an 88% reduction in tumor volume and 85% reduction in T2W signal intensity in median best change from baseline. We are pleased to note that 29 of the 42 patients who participated in Phase 2 of RINGSIDE entered the OLE and that we are seeing new responses in some of the patients who were receiving dosing twice a week and are now receiving 1.2 mg once daily. The Phase 3 registration segment (Part B) of RINGSIDE continues to enroll patients globally at a good pace with greater than 70% of the 154 patients we aim to enroll already dosed. These latest results from Phase 2 and OLE reinforce our belief that AL102 has the potential to be a best-in-class gamma secretase inhibitor and may offer a promising new treatment option to patients with unresectable, recurrent or progressive desmoid tumors."

Professor Robin Jones commented, "The outlook for patients with desmoid tumors appears to be improving, with one gamma secretase inhibitor already in registration with FDA, as an important new class of agents. These latest results on AL102 are unprecedented, showing meaningful clinical benefits across three key efficacy measures in a large proportion of treated patients as well as a manageable safety profile."

Andres Gutierrez MD PhD., Executive VP and Chief Medical Officer of Ayala, added, "The data from the Phase 2 segment of RINGSIDE continue to show efficacy across all dose cohorts with the earliest and deepest responses observed in the 1.2 mg once daily arm, the dose being evaluated in the ongoing Phase 3 segment. The large reductions in T2 signal intensity, as measured by MRI, are noteworthy as they have been correlated with loss of tumor cellularity and symptom control in patients undergoing treatment for DT. AL102 continues to be generally well tolerated and has a manageable safety profile as seen in all three dose arms. The safety results appear consistent with the GSI class."

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 study consists of two parts: Phase 2 (Part A) is an open-label, dose regimen finding study, and Phase 3 (Part B) is a double blind, placebo-controlled study and Open Label Extension utilizing the 1.2 mg once daily dose regimen selected based on data from Phase 2. Patients in Phase 2 were randomized to one of three dose regimens of AL102 (n=14 each), including 1.2 mg once daily (QD), 4 mg twice a week (BIW) or 2 mg BIW. Patients in the intermittent dosing arms were allowed to rollover to the Open Label Extension to receive 1.2 mg once daily after evaluations were completed in the Phase 2 part.

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 (Blinded Independent Central Review)
• ORR per RECIST was 64% in evaluable patients across the 3 dose arms (n=36)
• Efficacy results continue to demonstrate a dose-response pattern favoring the 1.2 mg once daily arm
• First Partial Responses (PRs) observed at 16 weeks and 21 additional PRs and 1 Complete Response across all dose arms
• Early and deep volume (-52%) and T2 signal intensity (-58%) 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
  

Best overall responses for the three dose arms in the evaluable population of Part A and OLE, as determined by blinded independent central review (BICR), are summarized in the table below:

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