On June 13, 2023 Starton Therapeutics Inc. ("Starton" or "the Company"), a clinical stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, reported updates on its Phase 1b STAR-LLD clinical trial of its investigational continuous delivery lenalidomide in multiple myeloma (Press release, Starton Therapeutics, JUN 13, 2023, View Source [SID1234632683]).
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The U.S. Food and Drug Administration ("FDA") notified the Company that it may proceed with the U.S.-based program in second-line transplant-ineligible patients using the combination of STAR-LLD, Velcade, and dexamethasone. This treatment paradigm will replace oral Revlimid with STAR-LLD. The planned study that follows this development will evaluate six patients for tolerability, immune biomarkers, and signals of efficacy of continuously delivered lenalidomide at the highest planned daily dose. The study is expected to accrue six patients in the United States in three to four centers over a period of 10 months and will provide readouts in the tolerability of the regimen, the impact of continuous delivery on immune function by measuring biomarkers of T-cell, NK-cell, and B-cell upregulation, and cytokine production induced by lenalidomide. It will also provide signals of efficacy in assessing response rates, duration of response, progression free survival, and changes in minimal residual disease.
Pedro Lichtinger, chairman and CEO of Starton Therapeutics commented, "Today’s announcement marks a significant development for Starton and patients in need of approved drugs and improved quality of life, and we are excited to begin this critical program in transplant-ineligible patients with multiple myeloma. This study will provide initial evidence of the impact of continuous delivery of lenalidomide both in terms of safety and efficacy, as well as provide clarity for signals of improvement in patients outcomes."
As part of the development plans, the FDA agreed to have a meeting to review the initial data on safety and activity from the study as an interim analysis, while patients continue treatment for efficacy endpoints. This interim review is aimed at helping develop the plans for the approval path forward with Phase 2 studies for multiple myeloma, as well as other malignancies where lenalidomide has shown activity but is not approved for the new indications planned for study.
Dr. Jamie Oliver, Starton’s chief medical officer noted, "We are very happy with the agreed protocol, which allows a quick read for the key safety and efficacy data which we will review with the FDA. The upcoming Phase 1b clinical study in multiple myeloma is on track to begin enrollment in Q4 2023. Treatment of second-line patients at our proposed optimal dose of continuous lenalidomide in combination with the proteasome inhibitor Velcade and dexamethasone allows us to demonstrate activity in an established standard of care regimen by replacing Revlimid with STAR-LLD."
Starton has signed an agreement for a business combination with Healthwell Acquisition Corp. I (Nasdaq: HWEL) ("Healthwell"). Please see "Additional Information and Where to Find It" below for additional information related to the proposed business combination.
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide in development to expand and replace the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144 mcg/day continuous LLD and 20% tumor elimination vs. 0% ORR with active control with daily pulsatile once daily dosing. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid demonstrated the drug is well tolerated and is >93% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid. These data support the safety of the planned Phase 1 dose of 400 mcg/hr (9.6 mg a day) versus a standard 25 mg a day dose for Revlimid.