ASCO 2024 | Updated safety & efficacy data from MANIFEST-2: pelabresib plus ruxolitinib for myelofibrosis

Aaron Gerds, MD, MS, Cleveland Clinic, Cleveland, OH, presents the updated results of the Phase III MANIFEST-2 study (NCT04603495), which investigated a combination of pelabresib and ruxolitinib in patients with JAK inhibitor treatment-naïve myelofibrosis (MF). Dr Gerds emphasizes that the primary endpoint of a minimum reduction of 35% in spleen volume (SVR35) was met despite the secondary endpoint of a 50% reduction of mean absolute total symptom score (TSS) not reaching statistical significance. With the updated results, a benefit continues to be observed with the combination therapy; however, longer-term follow-up is necessary to assess the durability of response, as a sustained spleen volume response correlates with improved survival outcomes. Dr Gerds also comments on the slightly higher rate of progression to accelerated blast-phase disease, which has been noted for the combination arm when compared to single-agent pelabresib, highlighting that this imbalance may be due to random chance alone and that individual patients will need to be looked at to determine whether progression would have likely occurred regardless of the therapy. This interview took place during the 2024 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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