On November 2, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that data from the Phase 3 MANIFEST-2 trial of pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis will be presented during an oral presentation on Sunday, December 10, at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, MorphoSys, NOV 2, 2023, View Source [SID1234636777]). The conference is being held in San Diego, California, from December 9 to 12, 2023.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Pelabresib represents an opportunity to meaningfully improve the standard of care for patients with myelofibrosis, a community in dire need of more effective and well-tolerated treatment options," said Tim Demuth, M.D., Ph.D., MorphoSys Chief Research and Development Officer. "We will be sharing topline results from our pivotal MANIFEST-2 study in the coming weeks and look forward to presenting detailed findings at ASH (Free ASH Whitepaper) 2023 shortly thereafter. We are very excited about the potential of pelabresib and grateful for the efforts of everyone who is contributing to this research – the investigators, clinical trial staff members, our employees and, most importantly, every patient and caregiver."

MANIFEST-2 is a global, multicenter, double-blind, Phase 3 study investigating pelabresib in combination with ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis (those who have not been previously treated with a JAK inhibitor). A total of 431 patients were randomized in the study, making it one of the largest myelofibrosis studies conducted to date.

The primary endpoint of the study is the proportion of patients who achieve a 35% or greater reduction in spleen volume (SVR35) from baseline at 24 weeks. A key secondary endpoint is the proportion of patients achieving a 50% or greater improvement in total symptom score (TSS50), as measured by the Myelofibrosis Symptom Assessment Form v4.0, from baseline at 24 weeks. The study is also assessing the absolute change in total symptom score (TSS) from baseline at week 24, percentage change in TSS from baseline at week 24, progression-free survival, overall survival, duration of the splenic and total symptom score responses, and improvement in bone marrow fibrosis, among other endpoints.

One additional abstract on pelabresib and six abstracts on tafasitamab, marketed in the U.S. as Monjuvi and outside the U.S. by Incyte as Minjuvi, were accepted for presentation and publication at ASH (Free ASH Whitepaper) 2023.

ASH 2023 Accepted Abstracts
Abstracts listed below include both MorphoSys-led and partner abstracts.

Abstract Title Abstract Number Date/Time
Pelabresib
ORAL
Pelabresib in Combination with Ruxolitinib for Janus Kinase Inhibitor Treatment-Naïve Patients with Myelofibrosis: Results of the MANIFEST-2 Randomized, Double-Blind, Phase 3 Study
#628
Sunday, December 10, 4:30 p.m. – 6:00 p.m. PST / Monday, December 11, 1:30 a.m. – 3:00 a.m. CET

Presentation Time: 5:15 p.m. PST
POSTER
Assessment of Minimal Clinically Important Difference in Patient-Reported Myelofibrosis-Associated Symptoms Using an Anchor-Based Analysis Based on MANIFEST Arm 3 Data
#3195
Sunday, December 10,
6:00 p.m. – 8:00 p.m. PST / Monday, December 11, 3:00 a.m. – 5:00 a.m. CET
Tafasitamab
ORAL
Tafasitamab for the Treatment of Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) in the US Real-World Setting
#265
Saturday, December 9,
2:00 p.m. – 3:30 p.m. PST / 11:00 p.m. – 12:30 a.m. CET

Presentation Time: 2:00 p.m. PST
POSTER
Real-World Use of Tafasitamab (tafa) for Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) Among Racial and Ethnic Minorities in the United States
#2415 Saturday, December 9, 5:30 p.m. – 7:30 p.m. PST / Sunday, December 10, 2:30 a.m. – 4:30 a.m. CET
POSTER
Tafasitamab in Combination with a CD20xCD3 Bispecific T-cell Engager Significantly Prolongs Survival in Preclinical Lymphoma Models
#2813 Sunday, December 10, 6:00 p.m. – 8:00 p.m. PST / Monday, December 11, 3:00 a.m. – 5:00 a.m. CET
PUBLICATION
realMIND: A Prospective and Retrospective Study to Characterize Real-World Use of Tafasitamab Plus Lenalidomide in US Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, With a Focus on Patients from Minority Groups
N/A N/A
PUBLICATION
Estimates of Survival and Life Expectancy with Tafasitamab plus Lenalidomide in the L-MIND Study Compared with Real-World Standard-of-Care for Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
N/A N/A
PUBLICATION
A Multicenter, Open-label, Phase 1b/2 Study to Evaluate the Effects of Maplirpacept in Combination with Tafasitamab and Lenalidomide in People with Relapsed or Refractory Diffuse Large B-cell Lymphoma
N/A N/A