lenalidomide (STAR-LLD SC) / Starton Therap - LARVOL DELTA

Starton Therapeutics Granted New U.S. Patent #12,390,457 Titled “Stable Solutions of Immunomodulatory Imide Compounds for Parenteral Use” a Formulation of STAR-LLD (GlobeNewswire) - "New U.S. patent provides IP coverage for the formulation to 2042."

Patent • Multiple Myeloma

Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM) (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Starton Therapeutics, Inc | Trial completion date: Sep 2024 ➔ Mar 2027 | Trial primary completion date: Jul 2024 ➔ May 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Starton Therapeutics Announces Phase 2a Clinical Trial for Continuous Low-Dose Lenalidomide (STAR-LLD) in Multiple Myeloma Open for Enrollment (GlobeNewswire) - "Starton Therapeutics...announced today Gabrail Cancer Center (GCC) in Canton, Ohio is now activated and open for enrolling patients in its Phase 2a clinical trial evaluating their continuous low-dose lenalidomide, STAR-LLD, for the treatment of multiple myeloma (MM)....Regional Medical Oncology Center, located in Wilson, NC, has also opened as the trial’s second active clinical site....Continuous SC infusion (STAR-LLD) in combination with dexamethasone and a protease inhibitor (PI) will be compared to oral lenalidomide (Revlimid) in combination with dexamethasone and a PI. The study will include at least 24 patients randomized to STAR-LLD and oral lenalidomide (Revlimid)....Starton anticipates opening approximately 10 clinical sites."

Trial status • Multiple Myeloma

Continuous subcutaneous lenalidomide delivery improves the therapeutic index and avoids drug-related grade 3/4 hematologic toxicity in patients with relapsed/refractory multiple myeloma (AACR 2025) - "Four patients were previously exposed to Len, one of which was discontinued from a prior regimen because of severe fatigue, and 6 had received prior bortezomib... Continuous delivery of low dose Len provides meaningful efficacy and improved tolerability with no grade >3 drug-related hematologic toxicity. Further studies in MM and chronic lymphocytic leukemia are planned."

Clinical • Late-breaking abstract • Chronic Lymphocytic Leukemia • Hematological Malignancies • Multiple Myeloma • Oncology

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 (GlobeNewswire) - P1/2 | N=6 | NCT06087653 | Sponsor: Starton Therapeutics, Inc | "Phase 1b results: Six relapsed/refractory MM patients were enrolled from two U.S. community-based investigational sites in the Phase 1b study...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."

P1 data • Multiple Myeloma

Starton Therapeutics to Present Poster at the American Association for Cancer Research (AACR) Annual Meeting 2025 (GlobeNewswire) - "Starton Therapeutics Inc...announced today that the Company will present a poster at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place in Chicago, IL, from April 25-30, 2025."

Clinical data • Multiple Myeloma

Bone marrow cancer [Google translation] (Danish Medicines Council) - "The Medical Council has approved an addendum that replaces the previous recommendation regarding maintenance treatment with lenalidomide as a possible standard treatment after high-dose chemotherapy with stem cell support for patients with newly diagnosed bone marrow cancer (version 2.0)."

Reimbursement • Multiple Myeloma

Early Results from Multiple Myeloma Clinical Trial Prove Cancer Drug Combination Provides Longer Response and Potential Benefit in Disease-Free Survival (University of Maryland Medical Center) - "'The results of this phase 3 study pave the way for the combination of daratumumab and lenalidomide to become a new standard maintenance therapy post-transplant in multiple myeloma patients,' said Taofeek Owonikoko, MD, PhD..."

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Starton Therapeutics Announces Successful Feasibility Demonstration of STAR-LLD Using BD Evolve On-Body Injector (GlobeNewswire) - "Starton Therapeutics Inc...announced today their successful feasibility demonstration to deliver their low-dose lenalidomide formulation, STAR-LLD, utilizing the BD Evolve On-body Injector. The in-depth study evaluated several critical parameters to demonstrate the capability of the device to successfully deliver STAR-LLD at a continuous low-dose using the on-body injector....Phase 2 clinical trials in chronic lymphocytic leukemia and multiple myeloma are planned for 2025."

Clinical • New P2 trial • Chronic Lymphocytic Leukemia • Multiple Myeloma • Oncology

Starton Therapeutics Strengthens Clinical Development Strategy Following Successful Scientific Advisory Board Meeting at ASCO 2024 (GlobeNewswire) - "Starton Therapeutics Inc...is pleased to announce its successful scientific Advisory Board meeting held during the American Society of Clinical Oncology (ASCO) Annual Meeting 2024...'The feedback from the Advisory Board enhances our study design and introduces us to innovative ideas that we believe will help drive the successful clinical development of STAR-LLD in oncology. As we advance into the preliminary stages of our STAR-LLD Phase 2 clinical trials, receiving unbiased third-party information provides us invaluable support.'"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Starton Therapeutics Announces 100% Partial Response or Better in Multiple Myeloma Patients in Interim, Top-line Data from STAR-LLD Phase 1b Clinical Trial (GlobeNewswire) - "Starton Therapeutics Inc...announced today positive interim top-line data from its low-dose lenalidomide STAR-LLD Phase 1b clinical trial in multiple myeloma (MM). The study, designed to assess the safety, pharmacokinetics, and efficacy of the Company’s STAR-LLD in combination with dexamethasone and bortezomib (Velcade), met the primary objective of safety and tolerability while being administered by continuous subcutaneous (SC) infusion. All six patients achieved a partial response (PR) or better within 1-3 cycles....Phase 2 studies in MM and chronic lymphocytic leukemia (CLL) are planned for 2025."

P1 data • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Starton Therapeutics Announces Enrollment Completion for STAR-LLD Phase 1b Clinical Trial in Multiple Myeloma (GlobeNewswire) - "Starton Therapeutics Inc...announced today the successful completion of enrollment for its STAR-LLD Phase 1b clinical trial in multiple myeloma...The study, which is assessing the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in combination with dexamethasone and bortezomib (Velcade), was originally anticipated to take ten months to enroll....As part of the development plans agreed to with the FDA, the Company will prepare an initial summary of data on safety and activity while patients continue treatment for efficacy endpoints. This interim review for the End of Phase 1 meeting, anticipated for 4Q24, is aimed at helping develop the plans for the approval path forward with Phase 2 studies for MM and other malignancies where lenalidomide has shown activity but is not approved."

Enrollment closed • FDA event • Hematological Malignancies • Multiple Myeloma • Oncology

Adding immune modulator to targeted therapy does not improve survival in difficult-to-treat thyroid cancer (Eurekalert) - "...Ari Rosenberg, MD, and Everett Vokes, MD, set out to test the safety and efficacy of cediranib, a TKI that targets multiple VEGFRs.'With this scope, we set out to evaluate whether immunomodulation by lenalidomide in combination with cediranib would improve disease-free survival over cediranib alone,' said Rosenberg...Additional study authors include...Chih-Yi Liao...Walter Stadler..."

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Starton Therapeutics Announces Opening of Second Clinical Site for STAR-LLD Phase 1b Trial in Multiple Myeloma and Provides Study Update (GlobeNewswire) - "Starton Therapeutics Inc...announced Regional Medical Oncology Center (RMOC) in Wilson, NC as the second site activated in the STAR-LLD Phase 1b clinical trial....Remarkably, the trial is progressing ahead of schedule and with the addition of RMOC is now projected to conclude enrollment by Q1/2024."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Starton Therapeutics Announces Initial Key Safety and Efficacy Signals with STAR-LLD in Patients with Relapsed or Refractory Multiple Myeloma (GlobeNewswire) - "Starton Therapeutics...announced today initial key safety and efficacy signals of its STAR-LLD Phase 1b clinical trial in multiple myeloma....Study enrollment is ahead of schedule with half of the patients enrolled and complete enrollment is expected by Q3/24. Early data may suggest superiority in safety compared to oral Revlimid....Clinical data reflect the unexpected superior responses seen in animals -- a 50% or greater decrease in M-protein concentration was observed in the first 2 patients after their first cycle of treatment."

Enrollment status • P1 data • Multiple Myeloma

Starton Therapeutics to Present at Biotech Showcase 2024 in San Francisco (GlobeNewswire) - "Starton Therapeutics Inc...today announced that Pedro Lichtinger, Chairman & Chief Executive Officer of Starton Therapeutics, will present a company overview including an update on interim data of its ongoing STAR-LLD Phase 1B continuous delivery of lenalidomide. The presentation is taking place at Biotech Showcase being held in San Francisco, CA on January 8-10, 2024."

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Novel therapeutic options and quadruplet regimens for newly diagnosed multiple myeloma (YouTube) - "Paul Richardson, MD...comments on the changing landscape of treatment for newly diagnosed multiple myeloma (NDMM), emphasizing the movement to quadruplet regimens. Dr Richardson also discusses the SKylaRk trial (NCT04430894), which demonstrated that the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) is a well-tolerated and efficacious regimen."

Interview • Video

Multiple Myeloma Face-Off: Karmanos Cancer Institute vs Cleveland Clinic : Episode 9: Cross Q&A: Clinical Application of Ixa-Len-Dex for Patients With MM (Cancer Network) - "Experts on multiple myeloma discuss the clinical applications of ixazomib-lenalidomide-dexamethasone combination therapy."

Video

Health-Related Quality Of Life In Patients With Myeloma Multiple Not Eligible For Transplant Treated With Fixed Duration Bortezomibmelphalan-Prednisone Compared To Continuous Lenalidomidedexametasone (SIE 2023) - P=NA | N=129 | NCT03829371 | "After an initial impairment of HRQoL with VMP vs Rd, the treatment-free interval after VMP was associated with a significant improvement of HRQoL as compared with continuous Rd. Frail pts had poor HRQoL improvements over time, as compared with fit and intermediate-fit pts."

Clinical data

Carfilzomib-Lenalidomide-Dexametasone (Krd) Vs. Lenalidomidedexametasone (Rd) In Newly Diagnosed Fit Or Intermediate Patients Fit With Multiple Myeloma Not Suitable For Autologous Transplant: Emn20 Phase III Randomized Trial (SIE 2023) - P3 | N=101 | EMN20 (NCT04096066) | "The analysis of the primary MRD endpoint is planned when all pts have received treatment for 2 y (Q4 of 2023): results will be presented at the meeting."

P3 data

Multiple Myeloma Face-Off: Karmanos Cancer Institute vs Cleveland Clinic : Episode 4: CARTITUDE-4: Cilta-Cel in Lenalidomide-Refractory MM (Cancer Network) - "...discusses phase 3 results from the CARTITUDE-4 study investigating ciltacabtagene autoleucel in patients with lenalidomide-refractory multiple myeloma."

Video

Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM) (clinicaltrials.gov) - P1/2 | N=6 | Recruiting | Sponsor: Starton Therapeutics, Inc

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Immune System Traits Linked With Remission in Multiple Myeloma (AJMC) - "'We found a strong correlation between sustained MRD negativity and prolonged survival,' said senior study author C. Ola Landgren, MD, PhD...'In fact, patients who were treated with modern combination therapy and achieved and sustained MRD negativity for at least two years were highly likely to remain free from multiple myeloma 10 years later.'"

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Health-Related Quality Of Life In Newly Diagnosed Multiple Myeloma Patients Not Eligible For Transplant And Frail Treated With Daratumumab, Lenalidomide And Dexamethasone: Subgroup Analysis Of The MAIA Study (SIE 2023) - No abstract available.

Clinical

Daratumumab Plus Lenalidomide And Dexamethasone (D-Rd) Versus Lenalidomide And Dexamethasone (Rd) In Newly Diagnosed Multiple Myeloma Patients Not Eligible For Transplantation (Ndmm): Clinical Evaluation Of Relevant Subgroups Of The Phase 3 MAIA Trial (SIE 2023) - No abstract available.

P3 data