Pharma Focus America

Fda Grants Starton Therapeutics Authorization for Phase 1b Clinical Trial of Star-lld Lenalidomide in Multiple Myeloma

Tuesday, June 13, 2023

Starton Therapeutics Inc., a biotechnology company in the clinical stage, has issued an update on its Phase 1b STAR-LLD clinical trial for continuous delivery lenalidomide in multiple myeloma. The U.S. Food and Drug Administration (FDA) has given approval for the company to proceed with the U.S.-based program for second-line transplant-ineligible patients. The trial will utilize a combination of STAR-LLD, Velcade, and dexamethasone, replacing oral Revlimid with STAR-LLD. Its aim is to assess the tolerability, immune biomarkers, and signals of efficacy of continuously delivered lenalidomide at the highest planned daily dose.

The study will enroll six patients in the United States over a 10-month period, conducted across three to four centers. It will evaluate the regimen's tolerability, measure biomarkers to assess the impact of continuous delivery on immune function, and provide signals of efficacy by analyzing response rates, duration of response, progression-free survival, and changes in minimal residual disease.

Pedro Lichtinger, chairman and CEO of Starton Therapeutics, expressed excitement about the program's significance for patients in need of approved drugs and improved quality of life. He stated that the study would provide initial evidence regarding the safety and efficacy of continuous delivery of lenalidomide, as well as clarity on potential improvements in patient outcomes.

The FDA has agreed to conduct an interim analysis of safety and activity data from the study, while patients continue treatment for efficacy endpoints. This analysis will assist in developing plans for the approval path forward, including Phase 2 studies for multiple myeloma and other malignancies where lenalidomide has demonstrated activity but lacks approval for the intended indications.

Dr. Jamie Oliver, Starton's chief medical officer, expressed satisfaction with the agreed protocol, which allows for a prompt review of essential safety and efficacy data with the FDA. The Phase 1b clinical study in multiple myeloma is set to commence enrollment in the fourth quarter of 2023. By treating second-line patients with continuous lenalidomide in combination with Velcade and dexamethasone, the study aims to demonstrate activity within an established standard of care regimen by replacing Revlimid with STAR-LLD.

Starton has also entered into an agreement for a business combination with Healthwell Acquisition Corp. I, which is expected to further support its development plans.

STAR-LLD is a continuous delivery lenalidomide being developed as a potential replacement for the standard of care in multiple myeloma and chronic lymphocytic leukemia. Preclinical studies have shown promising results, with STAR-LLD significantly reducing tumor growth compared to daily lenalidomide treatment. Phase 1 bioavailability studies have demonstrated the drug's safety and high bioavailability, supporting the planned Phase 1 dose for clinical trials.

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