On May 12, 2022 MorphoSys AG reported to Present New Data on Pelabresib and Monjuvi (tafasitamab-cxix) at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meetings
12.05.2022 / 16:45
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Media Release
BOSTON, Mass., USA, May 12, 2022

MorphoSys to Present New Data on Pelabresib and Monjuvi (tafasitamab-cxix) at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meetings

Efficacy and safety data from the ongoing Phase 2 MANIFEST study of pelabresib in myelofibrosis will be featured during an oral presentation at the EHA (Free EHA Whitepaper) 2022 Hybrid Congress

Translational research that suggests pelabresib’s potential disease modifying effect in patients living with myelofibrosis will be shared during an oral presentation at the EHA (Free EHA Whitepaper) 2022 Hybrid Congress

Overall survival data from the observational, retrospective cohort RE-MIND2 study of tafasitamab in relapsed or refractory diffuse large B-cell lymphoma will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced that new data on pelabresib and tafasitamab, marketed in the U.S. as Monjuvi and in Europe as Minjuvi, will be presented during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2022) in Chicago from June 3 – 7, 2022 and the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress (EHA 2022) in Vienna, Austria, from June 9 – 12, 2022.

"The data presented at this year’s EHA (Free EHA Whitepaper) and ASCO (Free ASCO Whitepaper) congresses showcase the breadth, depth and potential of our growing pipeline of cancer medicines," said Malte Peters, M.D., MorphoSys Chief Research and Development Officer. "At EHA (Free EHA Whitepaper) 2022, we’re excited to be presenting the latest results from the ongoing Phase 2 MANIFEST trial. These data suggest the potential of pelabresib, if approved, to change the current standard of care in the first-line treatment of myelofibrosis, a difficult-to-treat bone marrow cancer for which only limited treatment options are available. Further, at ASCO (Free ASCO Whitepaper) 2022, we will present new data from the RE-MIND2 study. This trial is using real world data to investigate the potentially prolonged survival benefit tafasitamab may offer to patients living with relapsed or refractory diffuse large B-cell lymphoma, an aggressive and debilitating disease."

Highlights from the presentations at EHA (Free EHA Whitepaper) 2022 include:

– An oral presentation of clinical data from the ongoing Phase 2 MANIFEST study investigating pelabresib in combination with ruxolitinib for the treatment of patients with myelofibrosis who had not previously been treated with a JAK inhibitor (JAK inhibitor-naive) and patients with suboptimal response to ruxolitinib treated with pelabresib in combination with ruxolitinib (Abstract S198)

– An oral presentation of translational research from the ongoing Phase 2 MANIFEST study that suggests pelabresib’s potential disease modifying effect in patients with myelofibrosis (Abstract S192)

– A poster presentation of data from a matching-adjusted indirect comparison (MAIC) analysis of pelabresib in combination with ruxolitinib from the ongoing, Phase 2 MANIFEST study versus ruxolitinib, fedratinib or momelotinib monotherapy in patients with intermediate or high-risk myelofibrosis (P1029)

– A poster presentation that outlines the design and inclusion criteria of the ongoing Phase 3 MANIFEST-2 study, which is exploring the effectiveness and safety of pelabresib in combination with ruxolitinib in JAK inhibitor-naive myelofibrosis patients (Abstract P1030)

Highlights from the presentations at ASCO (Free ASCO Whitepaper) 2022 include:

– A poster presentation of subgroup analyses of the RE-MIND2 trial, an observational, retrospective cohort study exploring tafasitamab in combination with lenalidomide versus systemic therapies in patients with relapsed or refractory diffuse large B-cell lymphoma, for the primary endpoint, overall survival (Abstract 7560)

– A poster presentation that spotlights the progress of the ongoing, randomized Phase 3 frontMIND study, which is exploring the effectiveness and safety of tafasitamab in combination with lenalidomide and R-CHOP as a treatment for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma (Abstract TPS7590)

EHA 2022 Accepted Abstracts

Abstract Title Abstract Number Date/Time
ORAL

BET inhibitor pelabresib (CPI-0610) combined with ruxolitinib in patients with myelofibrosis — JAK inhibitor-naive or with suboptimal response to ruxolitinib — preliminary data from the MANIFEST study S198 Saturday, June 11, 2022
11:30 a.m. – 12:45 p.m. CEST / 5:30 a.m. – 6:45 a.m. EST
ORAL

Single-cell RNA profiling of myelofibrosis patients reveals pelabresib-induced decrease of megakaryocytic progenitors and normalization of CD4+ T cells in peripheral blood S192 Saturday, June 11, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. – 11:45 a.m. EST
POSTER

Matching-adjusted indirect comparison (MAIC) of pelabresib (CPI-0610) in combination with ruxolitinib vs. ruxolitinib or fedratinib monotherapy in patients with intermediate or high-risk myelofibrosis P1029 Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. – 11:45 a.m. EST
POSTER

MANIFEST-2, a global, Phase 3, randomized, double-blind, active-control study of pelabresib (CPI-0610) and ruxolitinib vs. placebo and ruxolitinib in JAK-inhibitor-naive myelofibrosis patients P1030 Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. – 11:45 a.m. EST
POSTER (Incyte)

inMIND: A Phase 3 study of tafasitamab plus lenalidomide and rituximab versus placebo plus lenalidomide and rituximab for relapsed/refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) P1103 Friday, June 10, 2022
4:30 p.m. – 5:45 p.m. CEST / 10:30 a.m. – 11:45 a.m. EST
PUBLICATION

frontMIND: A Phase 3, randomized, double-blind study of tafasitamab + lenalidomide + R-CHOP vs R-CHOP alone for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma PB2113 N/A
PUBLICATION

Pharmacokinetics and pharmacodynamics in firstMIND: A Phase 1B, open-label, randomized study of tafasitamab ± lenalidomide + R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma PB2110 N/A
PUBLICATION

MINDway: A Phase 1B/II dose optimization study to assess safety and pharmacokinetics of tafasitamab + lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma PB2112 N/A
PUBLICATION

realMIND: A prospective, multicenter, observational study of patients with relapsed/refractory diffuse large B-cell lymphoma starting second/third-line therapy and not receiving a stem cell transplant PB2109 N/A
PUBLICATION

Subgroup analysis in RE-MIND2, an observational, retrospective cohort study of tafasitamab + lenalidomide versus systemic therapies in patients with relapsed/refractory diffuse large B-cell lymphoma PB2111 N/A

ASCO 2022 Accepted Abstracts

Abstract Title Abstract Number Date/Time
POSTER

Subgroup analysis in RE-MIND2, an observational, retrospective cohort study of tafasitamab plus lenalidomide versus systemic therapies in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) 7560 Saturday, June 4
3:00 p.m. CEST / 9:00 a.m. EST
POSTER

frontMIND: A Phase 3, randomized, double-blind study of tafasitamab + lenalidomide + R-CHOP versus R-CHOP alone for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma. TPS7590 Saturday, June 4, 2022
3:00 p.m. CEST / 9:00 a.m. EST
POSTER (Incyte)

inMIND: A Phase 3 study of tafasitamab plus lenalidomide and rituximab versus placebo plus lenalidomide and rituximab for relapsed/refractory follicular or marginal zone lymphoma TPS7583 Saturday, June 4, 2022
3:00 p.m. CEST / 9:00 a.m. EST
PUBLICATION

Pharmacokinetics (PK) and pharmacodynamics (PD) in First-MIND: a phase Ib, open-label, randomized study of tafasitamab (tafa) ± lenalidomide (LEN) in addition to R‑CHOP in patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL) e19553 N/A
PUBLICATION

Preferences and Perceptions Regarding Treatment Decision-Making For Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) e18710 N/A

Please refer to the EHA (Free EHA Whitepaper) (View Source) and ASCO (Free ASCO Whitepaper) (View Source) online programs for full session details and data presentation listings.