Starton Therapeutics Reports 100% Partial Response or Better in Multiple Myeloma Phase 1b Trial

Starton Therapeutics Inc., a clinical-stage biotechnology firm, has revealed promising interim top-line data from its Phase 1b STAR-LLD clinical trial for multiple myeloma (MM). This trial is focused on evaluating the safety, pharmacokinetics, and efficacy of their low-dose lenalidomide (STAR-LLD) when administered continuously via subcutaneous (SC) infusion alongside dexamethasone and bortezomib (Velcade®). Encouragingly, the trial met its primary safety and tolerability objectives, with all six participating patients achieving a partial response (PR) or better within one to three cycles of treatment.

Chief Medical Officer, Dr. Jamie Oliver, noted the significance of these findings. Lenalidomide has been a crucial component in MM treatment, with Revlimid® being a widely utilized drug due to its effectiveness in combination therapies. However, the toxicity associated with Revlimid® can be intolerable for some patients. The interim data from the STAR-LLD trial indicates that the drug offers lower toxicity at therapeutic doses, potentially making lenalidomide more tolerable for MM patients.

Pedro Lichtinger, Chairman and CEO of Starton, emphasized the challenge of lenalidomide intolerance, which can negatively impact treatment efficacy and overall survival. Many patients face dose modifications or treatment discontinuation due to severe side effects. The continuous delivery of lenalidomide at a tolerable dose, as demonstrated in this trial, directly addresses these issues, offering hope for improved patient outcomes.

Tolerance, referring to a patient’s ability to endure minimal adverse effects from a drug, is critical in treatment continuity. Severe intolerance can lead to treatment discontinuation. Common side effects of Revlimid® during continuous maintenance treatment include neutropenia (79%), thrombocytopenia (72%), anemia (21%), and gastrointestinal issues (40%), leading to treatment interruptions in about 30% of patients. In contrast, the Phase 1b trial of STAR-LLD reported no grade 3 or higher adverse events for neutropenia or thrombocytopenia. Diarrhea was observed in 33% of the patients at grades 1 and 2, which is favorable compared to the higher incidence and severity seen with oral Revlimid®. Additionally, half of the trial participants reported a localized rash at the injection site, and one case of a grade 3 rash was treated. Other side effects like nausea and fatigue were noted at grades 1 and 2. Most reported events were not linked to the drug.

The company plans to compile a summary of the safety and activity data for submission to the U.S. Food and Drug Administration (FDA) while continuing to treat patients for efficacy endpoints. They anticipate launching Phase 2 studies in MM and chronic lymphocytic leukemia (CLL) by 2025.

STAR-LLD, a continuous delivery formulation of lenalidomide, aims to redefine the standard of care for prevalent blood cancers such as MM and CLL. In preclinical studies, STAR-LLD significantly outperformed traditional lenalidomide, leading to an 80% reduction in tumor size over a 28-day cycle compared to a five-fold increase with daily lenalidomide. The continuous delivery method also achieved a 100% overall response rate (ORR), with 20% of animals becoming tumor-free after 100 days, compared to a 0% ORR in those treated with a higher dose of daily lenalidomide. Furthermore, a Phase 1 bioavailability study in healthy men showed that STAR-LLD is well tolerated, with greater than 91% bioavailability through the subcutaneous route and significantly lower peak concentrations (Cmax) compared to oral Revlimid®.

Starton Therapeutics is dedicated to transforming standard-of-care therapies through its proprietary continuous delivery technology, aiming to improve the efficacy and tolerability of approved drugs for cancer patients.