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ASH 2024 | Interim results from the PROMise study of OPN-2853 with ruxolitinib in myelofibrosis

Adam Mead, MA, BM, BCh, MRCP, FRCPath, PhD, Oxford University Hospitals NHS Foundation Trust, Oxford, UK, discusses the interim analysis of the PROMise study (ISRCTN12451433), a clinical trial combining the BET inhibitor OPN-2853 with ruxolitinib in patients with myelofibrosis who have had a suboptimal response to standard treatment. So far, the combination has shown promising efficacy signals and has been well tolerated, with only two dose-limiting toxicities reported. The study aims to establish a recommended Phase II dose level and expand the cohort for a full efficacy analysis. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.

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Transcript (AI-generated)

PROMise is a study that we’re running through the CRUK combinations alliance. It’s testing a new BET inhibitor treatment used in combination with ruxolitinib for patients with myelofibrosis who’ve had a suboptimal response to standard single agent ruxolitinib treatment. So we’re reporting the interim analysis at this meeting. The trial is aiming to test the safety of combining OPN-2853 with ruxolitinib in patients with myelofibrosis...

PROMise is a study that we’re running through the CRUK combinations alliance. It’s testing a new BET inhibitor treatment used in combination with ruxolitinib for patients with myelofibrosis who’ve had a suboptimal response to standard single agent ruxolitinib treatment. So we’re reporting the interim analysis at this meeting. The trial is aiming to test the safety of combining OPN-2853 with ruxolitinib in patients with myelofibrosis. So far the combination has been well tolerated. We’ve only reported two dose-limiting toxicities and we’ve moved all cohorts in the trial forward to the 80 milligram dose level and we’re seeing very encouraging signals of efficacy with some spleen responses measured by palpation. So the idea of the study is once we’ve established the recommended Phase II dose level we will expand the cohort at that dose level for a full efficacy analysis in order to determine whether there’s enough of an efficacy signal to take this forward for a more advanced phase of clinical development.

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Disclosures

Incyte: Consultancy, Honoraria; Alethiomics: Consultancy, Current equity holder in private company, Current holder of stock options in a privately-held company, Research Funding; GSK: Consultancy, Honoraria, Research Funding; Karyopharm: Consultancy, Honoraria; Medscape: Honoraria; Ionis: Consultancy, Honoraria; Morphosys: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Galecto: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; Roche: Research Funding.