Novartis Discontinues Phase 3 Trial of Sabatolimab for Myelodysplastic Syndromes
Novartis Halts Sabatolimab Development for MDS
In a significant development in the pharmaceutical industry, Novartis has announced the discontinuation of its phase 3 STIMULUS-MDS2 trial for sabatolimab (MBG453), a drug targeting the Tim3 receptor, in the treatment of myelodysplastic syndromes (MDS). The trial, which began in 2020, aimed to evaluate the efficacy of sabatolimab in combination with azacitidine for previously untreated adult patients with intermediate, high, or very high-risk MDS who were not candidates for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT).
Trial Outcomes and Strategic Decision
The decision to discontinue the trial was based on the failure to meet the primary endpoint of improving overall survival compared to azacitidine plus placebo. This outcome follows the earlier phase 2 STIMULUS-MDS1 study, which also did not achieve its objectives, as reported in The Lancet Haematology journal. Novartis has stated that the discontinuation is part of a broader strategy to prioritize other programs within its portfolio that show more promise.
Implications for Tim3-Targeting Therapies
Sabatolimab's setback is a notable event in the competitive landscape of Tim3-targeting drugs. Novartis had been leading the development in this area, slightly ahead of competitors like GSK and AnaptysBio with their cobolimab candidate. However, the field has seen several challenges, with other companies also discontinuing their Tim3-targeting projects, including Roche and Bristol-Myers Squibb.
Ongoing Research and Future Directions
Despite these setbacks, research into Tim3-targeting therapies continues, with several companies still pursuing development in various cancer types. Incyte and Agenus are advancing verzistobart (INCAGN2390) in phase 2 trials for endometrial cancer, squamous cell carcinoma of the head and neck, and relapsed/refractory melanoma. Similarly, Servier/Symphogen and BeiGene are conducting phase 1/2 studies with their respective Tim3-targeting candidates in non-small cell lung cancer and other solid tumors.
This development underscores the complexities and challenges in developing effective cancer therapies, particularly in targeting novel pathways like Tim3. The discontinuation of the STIMULUS-MDS2 trial represents a significant moment in the ongoing quest to bring innovative treatments to patients with MDS and other cancers.