Starton Therapeutics presented positive Phase 1b data for STAR-LLD, a continuous low-dose lenalidomide therapy for relapsed/refractory multiple myeloma (MM), at the 2025 AACR Annual Meeting. The study showed promising efficacy and a favorable safety profile, paving the way for a Phase 2 trial. The data were presented by Dr. Nashat Gabrail of the Gabrail Cancer & Research Center.
This news holds significant implications for the treatment of MM. Current lenalidomide regimens often cause significant hematological toxicity, leading to dose reductions or treatment discontinuation. STAR-LLD’s ability to achieve efficacy without these severe side effects could offer a substantial improvement in patients’ quality of life and potentially improve treatment outcomes by allowing for continuous therapy. This continuous delivery method may provide a therapeutic advantage by maintaining consistent drug exposure and potentially overcoming drug resistance mechanisms.
The Phase 1b study enrolled six patients with relapsed/refractory MM. Remarkably, no patients experienced drug-related grade 3/4 hematologic toxicity. All six patients achieved an objective response (one complete response and five partial responses), with five continuing treatment at a median progression-free survival of over 10 months. Pharmacokinetic data showed that STAR-LLD achieved biologically active drug levels while minimizing peak concentrations, likely contributing to the improved tolerability. One patient withdrew due to a Grade 2 skin reaction.
The positive Phase 1b data strongly support the continued development of STAR-LLD. The upcoming Phase 2 trial will be crucial in confirming these findings in a larger patient population and further defining the role of STAR-LLD in the MM treatment landscape. If successful, this therapy could represent a significant advancement in MM care, offering a more tolerable and potentially more effective treatment option for patients with this challenging disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
