Starton Therapeutics Presents Positive Data from Phase 1b Study Evaluating STAR-LLD for the Treatment of Relapsed/Refractory Multiple Myeloma at the American Association for Cancer Research (AACR) Annual Meeting 2025

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25-04-2025

PARAMUS, N.J., April 25, 2025 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. ('Starton'), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today the presentation of positive data from a Phase 1b study evaluating STAR-LLD for the treatment of multiple myeloma (MM) at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place in Chicago, IL, from April 25-30, 2025.
'We are pleased to present the positive results from our Phase 1b study at this year's AACR meeting, which demonstrate the significant potential of our continuous low dose lenalidomide therapy, STAR-LLD, to treat patients with relapsed/refractory multiple myeloma,' said Pedro Lichtinger, Chairman and Chief Executive Officer of Starton Therapeutics.' Treatment with STAR-LLD also demonstrated impressive tolerability data, suggesting a highly differentiated and favorable safety profile. Based on the strength of these data, we look forward to advancing STAR-LLD into a Phase 2 clinical trial in the coming months.'
Poster Presentation Details:
Title: Continuous subcutaneous lenalidomide delivery improves the therapeutic index and avoids drug-related grade 3/4 hematologic toxicity in patients with relapsed/refractory multiple myelomaAbstract Presentation Number: LB207Session Title: Late-Breaking Research: Clinical Research 1Session Date and Time: Monday, April 28th at 2pm Location: Poster Section 53Poster Board Number: 4Presented by: Nashat Gabrail, MD, Gabrail Cancer & Research Center
Phase 1b results:
Six relapsed/refractory MM patients were enrolled from two U.S. community-based investigational sites in the Phase 1b study. Median age was 73, male to female ratio 1/1, Caucasian 100%, and median lines of previous therapy were 2 (range 1-7). Two patients were refractory and four were relapsed to their prior treatment. Four patients were previously exposed to lenalidomide, one of which was discontinued from a prior regimen because of severe fatigue, and all six had received prior bortezomib. Patients received 3-12 cycles of study therapy.
No patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy.
Non-hematologic toxicities did not exceed Grade 2
The PK/PD data minimized Cmax and lowered AUC while achieving biologically active doses and reducing toxicity
STAR-LLD pharmacokinetics produced median steady-state blood levels (Cmax) of 39 ng/mL (N=6) and were above the minimum target of 25 ng/mL.
All six patients receiving STAR-LLD achieved an objective response (1 CR and 5 PRs); one patient who achieved a partial response experienced a Grade 2 skin reaction during cycle 3 and withdrew from the study
Continuous treatment with STAR-LLD does not appear to significantly increase immune checkpoints associated with T cell exhaustion
Five patients are continuing treatment per protocol with a median PFS of > 10 months
Conclusion: Continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade >3 drug-related hematologic toxicity. Further studies in MM and chronic lymphocytic leukemia are planned.
About STAR-LLDSTAR-LLD is a continuous delivery lenalidomide (LLD) in development to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous 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 over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD and 20% of animals in this cohort were tumor-free after 100 days, compared to a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1 bioavailability study in healthy men comparing subcutaneous STAR-LLD to Revlimid® demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid®.
About Starton Therapeutics
Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer can receive continuous treatment to live better, longer. Starton's proprietary transdermal technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit www.startontx.com.
Forward Looking Statements
All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding our plans and objectives for future operations and expectations about current and future clinical trials, constitute 'forward-looking statements.' Forward-looking statements are subject to numerous conditions and known and unknown risks and uncertainties that could cause our actual results or events to differ materially from those included within the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, and except as required by law, Starton undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise.
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