Expert Interview
Discussing Morphosys' pelabresib in myelofibrosis with a clinical trialist in advance of the upcoming Phase 3 readout anticipated in Q4 2023
Ticker(s): MORInstitution: Moffitt Cancer Center
- Hematologist/Oncologist, and Assistant Member at Moffitt Cancer Center in the Department of Malignant Hematology.
- Currently manages 200-250 patients with myelofibrosis and is very familiar with the literature to date on Morphosys' pelabresib and noted he "was not involved in the phase 2 MANIFEST, but was involved in MANIFEST-2".
- Primary investigator on a number of myelofibrosis clinical trials including MANIFEST-2 (pelabresib), MOMENTUM (momelotinib), others sponsored by Janssen, Novartis, and Geron, and numerous other clinical trials.
Could you please describe your background, practice and give us an estimate how many patients you treat per year and how many patients you see per month?
Added By: chanell_adminZooming in into the patients' characteristics - could you give us the breakdown of patients that are indolent, intermediate or high- risk?
Added By: chanell_adminCan you walk us through the current treatment algorithm and explain what are the key changes in the 1st line treatment that happened with the approvals we've seen during the last 2 years?
Added By: chanell_adminHow do you expect these new drugs (Momelotinib, Pacritinib) to impact Ruxolitinib/Jakafi's place on the market? What is the remaining unmet medical need in the first line with these two new approvals?
Added By: chanell_adminWe would like to zoom in now into the MANIFEST_2 data read out that is coming out this year. What do you think is the minimum bar for pelabresib to show clinically meaningful benefit for patients? What would be sufficient for an accelerated approval on SVR35 and TSS50 end points? How important is it for MANIFEST_2 data to hit the Total Symptom Score end point and what would you like to see on this endpoint?
Added By: chanell_adminWhat did you think of the anti-fibrotic response that was described in the MANIFEST-1 study? How do you see the probability for MANIFEST-2 to repeat these findings? Based on currently available evidence - do you think Pelabresib could have disease modifying potential?
Added By: chanell_adminWhat is the Probability of Success that you would give to the MANIFEST-2 trial?
If Pelabresib gets approved - where would it fit in the treatment algorithm? In order to drive uptake, would you need to see a benefit on OS and PFS (neither of which are listed as secondary endpoints on clinicaltrials.gov).
Added By: chanell_adminIs there any evidence out there that suggests that improvement of Bone Marrow Fibrosis and reduction of mutation burden correlate with survival outcomes?
Added By: chanell_adminOn the scale from 1-10, could you please rate your excitement about Pelabresib?
Added By: chanell_adminAre You Interested In These Questions?
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