DGAP-News: MorphoSys AG / Key word(s): Miscellaneous
MorphoSys to Present New Data on Pelabresib and Monjuvi® (tafasitamab-cxix) at the 2022 European Hematology Association (EHA) and American Society of Clinical Oncology (ASCO) 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 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 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 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 Annual Meeting (ASCO 2022) in Chicago from June 3 – 7, 2022 and the 2022 European Hematology Association Hybrid Congress (EHA 2022) in Vienna, Austria, from June 9 – 12, 2022.
“The data presented at this year’s EHA and ASCO 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 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 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 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 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
ASCO 2022 Accepted Abstracts
MorphoSys is currently recruiting for the MANIFEST-2 study (NCT04603495). This study is a global, double-blind, randomized Phase 3 clinical trial with pelabresib in combination with ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-naive patients with myelofibrosis. The primary endpoint of the study is a ≥35% reduction in spleen volume (SVR35) from baseline at 24 weeks. A key secondary endpoint of the study is 50% or greater improvement in Total Symptom Score (TSS50) from baseline at 24 weeks.
Pelabresib is currently being investigated as a treatment for myelofibrosis and has not yet been evaluated or approved by any regulatory authorities.
In Europe, Minjuvi® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as an immunotherapeutic option in B-cell malignancies in several ongoing combination trials.
Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name MONJUVI® in the U.S., and marketed by Incyte under the brand name Minjuvi® in Europe, the UK and Canada.
XmAb® is a registered trademark of Xencor, Inc.
What are the possible side effects of MONJUVI?
- Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI.
- Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.
- Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.
The most common side effects of MONJUVI include:
- Feeling tired or weak
- Swelling of lower legs or hands
- Respiratory tract infection
- Decreased appetite
These are not all the possible side effects of MONJUVI.
- Have an active infection or have had one recently.
- Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
- You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
- Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.
You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.
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