EQS-Information: MorphoSys AG / Key phrase(s): Miscellaneous
MorphoSys Completes Enrollment of Section 3 MANIFEST-2 Examine of Pelabresib in Myelofibrosis with Topline Outcomes Anticipated by Finish of 2023
04.04.2023 / 22:01 CET/CEST
The issuer is solely accountable for the content material of this announcement.
Media Launch
Planegg/Munich, Germany, April 4, 2023
MorphoSys Completes Enrollment of Section 3 MANIFEST-2 Examine of Pelabresib in Myelofibrosis with Topline Outcomes Anticipated by Finish of 2023
Enrollment of Section 3 frontMIND research of tafasitamab in first-line diffuse giant B-cell lymphoma can be full
MorphoSys AG (FSE: MOR; NASDAQ: MOR) introduced in the present day that enrollment is full for MANIFEST-2, the continuing Section 3 research exploring the efficacy and security of pelabresib, an investigational BET inhibitor, together with ruxolitinib versus ruxolitinib alone in sufferers with myelofibrosis who haven’t beforehand been handled with a JAK inhibitor (JAK inhibitor-nave). The topline knowledge are actually anticipated by the top of 2023, sooner than beforehand anticipated.
Myelofibrosis which belongs to a bunch of illnesses known as myeloproliferative problems is a difficult-to-treat type of blood most cancers with restricted remedy choices. JAK inhibitors are a present normal of care remedy for myelofibrosis, which concentrate on relieving signs of the illness slightly than treating its trigger. However, with this remedy technique, solely about half of sufferers attain satisfactory illness management, and sturdiness of response is commonly restricted. Medical knowledge recommend synergistic results between BET inhibition and JAK inhibition in myelofibrosis, supporting the potential of this mixture remedy.
With so many sufferers left behind by present remedy choices for myelofibrosis, there’s a vital want for regimens that elevate the usual of take care of sufferers affected by this debilitating illness, stated Tim Demuth, M.D., Ph.D., Chief Analysis and Growth Officer, MorphoSys. Now that MANIFEST-2 has accomplished enrollment sooner than anticipated, we look ahead to the approaching insights into the therapeutic potential of pelabresib together with ruxolitinib for JAK inhibitor-nave sufferers with myelofibrosis. MANIFEST-2 is the most recent milestone in our efforts to enhance outcomes for blood most cancers sufferers and is a testomony to our continued dedication to the myelofibrosis neighborhood.
MANIFEST-2 is a worldwide, multicenter, double-blind, Section 3 research of greater than 400 sufferers who have been nave to JAK inhibitors. Sufferers have been randomized 1:1 to pelabresib together with ruxolitinib or placebo plus ruxolitinib. The first endpoint of the trial is the proportion of sufferers who obtain a 35% or better discount in spleen quantity at week 24 (often called SVR35). Discount in spleen measurement is a vital medical endpoint in myelofibrosis as a result of spleen enlargement displays illness exercise and may trigger important ache and discomfort.
The important thing secondary endpoint is the proportion of sufferers attaining a 50% or better enchancment in complete symptom rating, as measured by the Myelofibrosis Symptom Evaluation Kind v4.0, at week 24. Sufferers with myelofibrosis expertise a severely diminished high quality of life as a consequence of signs resembling extreme fatigue, fever and weight reduction. The Myelofibrosis Symptom Evaluation Kind is a validated self-assessment software designed particularly for myelofibrosis sufferers that may monitor modifications in these signs.
The MANIFEST-2 trial is supported by findings from the Section 2 MANIFEST trial of pelabresib together with ruxolitinib in sufferers with myelofibrosis, together with those that have been JAK inhibitor-nave. Up to date outcomes from MANIFEST introduced on the American Society of Hematology 2022 Annual Assembly and Exposition recommend that pelabresib together with ruxolitinib supplied extended enchancment in each spleen measurement and symptom severity at and past 24 weeks.
Enrollment of the Section 3 entranceMIND research can be full, with greater than 880 sufferers enrolled within the trial. entranceMIND is a worldwide, multicenter, randomized, double-blind, placebo-controlled trial exploring tafasitamab, marketed within the U.S. as Monjuvi and out of doors the U.S. by Incyte as Minjuvi, plus lenalidomide along with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP alone as a first-line remedy for high-intermediate and high-risk sufferers with diffuse giant B-cell lymphoma. The topline knowledge from this research are anticipated within the second half of 2025.
About Pelabresib
Pelabresib (CPI-0610) is an investigational selective small molecule designed to advertise anti-tumor exercise by inhibiting the perform of bromodomain and extra-terminal area (BET) proteins to lower the expression of abnormally expressed genes in most cancers. Pelabresib is being investigated as a remedy for myelofibrosis and has not but been evaluated or authorised by any regulatory authorities.
About Myelofibrosis
Myelofibrosis certainly one of a bunch of illnesses known as myeloproliferative problems is a difficult-to-treat type of blood most cancers thats characterised by bone marrow fibrosis (a buildup of scar tissue within the bone marrow), spleen enlargement and anemia (low pink blood cell counts) typically requiring periodic blood transfusions. Sufferers with myelofibrosis may also undergo from a variety of bodily signs, together with extreme fatigue, evening sweats, itching, elevated bleeding and important ache attributable to their enlarged spleen. For a lot of residing with myelofibrosis, the mix of signs typically severely impacts their high quality of life. At prognosis, a number of elements, resembling age, genetics and bloodwork, assist decide a sufferers long-term prognosis. About 90% of newly recognized sufferers have intermediate- to high-risk illness, which has a worse prognosis and a better chance of disease-associated signs. Immediately, myelofibrosis remedies revolve round the usage of medicines known as JAK inhibitors, which concentrate on relieving signs of myelofibrosis slightly than treating its trigger. However with this technique, solely about 50% of sufferers obtain satisfactory symptom management, and, sadly, that reduction fades with time for a lot of. Sufferers affected by myelofibrosis are in vital want of remedy choices that not solely tackle their signs but additionally change the general course of their illness.
About MANIFEST-2
MANIFEST-2 (NCT04603495) is a worldwide, double-blind, randomized Section 3 medical trial with pelabresib together with ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-nave sufferers with myelofibrosis. The first endpoint of the research is a 35% or better discount in spleen quantity (SVR35) from baseline at 24 weeks. The important thing secondary endpoint of the research is a 50% or better enchancment in complete symptom rating (TSS50) from baseline at 24 weeks. Constellation Prescription drugs, Inc., a MorphoSys firm, is the MANIFEST-2 trial sponsor.
About MANIFEST
MANIFEST (NCT02158858) is an open-label Section 2 medical trial of pelabresib in sufferers with myelofibrosis. The MANIFEST trial is evaluating pelabresib together with ruxolitinib in JAK-inhibitor-nave myelofibrosis sufferers (Arm 3), with a main endpoint of the proportion of sufferers with a 35% spleen quantity discount from baseline (SVR35) after 24 weeks of remedy. The trial can be evaluating pelabresib both as a monotherapy in sufferers who’re immune to, illiberal of, or ineligible for ruxolitinib and now not on the drug (Arm 1) or as add-on remedy together with ruxolitinib in sufferers with a suboptimal response to ruxolitinib or myelofibrosis development (Arm 2). Sufferers in Arms 1 and a couple of are being stratified based mostly on transfusion-dependent (TD) standing. The first endpoint for the sufferers in cohorts 1A and 2A, who have been TD at baseline, is conversion to transfusion independence for 12 consecutive weeks. The first endpoint for sufferers in cohorts 1B and 2B, who weren’t TD at baseline, is the proportion of sufferers with a 35% spleen quantity discount from baseline after 24 weeks of remedy. Constellation Prescription drugs, Inc., a MorphoSys firm, is the MANIFEST trial sponsor.
About Monjuvi (tafasitamab-cxix)
Tafasitamab is a humanized Fc-modified CD19 concentrating on immunotherapy. In 2010, MorphoSys licensed unique worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc area, which mediates B-cell lysis by apoptosis and immune effector mechanism together with Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Mobile Phagocytosis (ADCP).
In the USA, Monjuvi (tafasitamab-cxix) is authorised by the U.S. Meals and Drug Administration together with lenalidomide for the remedy of grownup sufferers with relapsed or refractory DLBCL not in any other case specified, together with DLBCL arising from low grade lymphoma, and who are usually not eligible for autologous stem cell transplant (ASCT). This indication is authorised underneath accelerated approval based mostly on total response charge. Continued approval for this indication could also be contingent upon verification and outline of medical profit in a confirmatory trial(s).
In Europe, Minjuvi (tafasitamab) acquired conditional advertising authorization together with lenalidomide, adopted by Minjuvi monotherapy, for the remedy of grownup sufferers with relapsed or refractory diffuse giant B-cell lymphoma (DLBCL) who are usually not eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic choice in B-cell malignancies in a number of ongoing mixture trials.
Monjuvi and Minjuvi are registered emblems of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys underneath the model title Monjuvi within the U.S., and marketed by Incyte underneath the model title Minjuvi in Europe and Canada.
XmAb is a registered trademark of Xencor, Inc.
Vital Security Info
What are the doable unintended effects of MONJUVI?
MONJUVI might trigger severe unintended effects, together with:
– Infusion reactions. Your healthcare supplier will monitor you for infusion reactions throughout your infusion of MONJUVI. Inform your healthcare supplier immediately in case you get fever, chills, rash, flushing, headache, or shortness of breath throughout an infusion of MONJUVI.
– Low blood cell counts (platelets, pink blood cells, and white blood cells). Low blood cell counts are frequent with MONJUVI, however will also be severe or extreme. Your healthcare supplier will monitor your blood counts throughout remedy with MONJUVI. Inform your healthcare supplier immediately in case you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.
– Infections. Critical infections, together with infections that may trigger loss of life, have occurred in individuals throughout remedies with MONJUVI and after the final dose. Inform your healthcare supplier immediately in case you get a fever of 100.4 F (38 C) or above, or develop any indicators and signs of an an infection.
The commonest unintended effects of MONJUVI embrace:
– Feeling drained or weak
– Diarrhea
– Cough
– Fever
– Swelling of decrease legs or arms
– Respiratory tract an infection
– Decreased urge for food
These are usually not all of the doable unintended effects of MONJUVI.
Name your physician for medical recommendation about unintended effects. Chances are you’ll report unintended effects to FDA at 1-800-FDA-1088.
Earlier than you obtain MONJUVI, inform your healthcare supplier about all of your medical circumstances, together with in case you:
– Have an lively an infection or have had one lately.
– Are pregnant or plan to grow to be pregnant. MONJUVI might hurt your unborn child. You shouldn’t grow to be pregnant throughout remedy with MONJUVI. Don’t obtain remedy with MONJUVI together with lenalidomide if you’re pregnant as a result of lenalidomide could cause delivery defects and loss of life of your unborn child.
– You need to use an efficient methodology of contraception (contraception) throughout remedy and for a minimum of 3 months after your closing dose of MONJUVI.
– Inform your healthcare supplier immediately in case you grow to be pregnant or assume that you could be be pregnant throughout remedy with MONJUVI.
– Are breastfeeding or plan to breastfeed. It isn’t recognized if MONJUVI passes into your breastmilk. Don’t breastfeed throughout remedy for a minimum of 3 months after your final dose of MONJUVI.
You must also learn the lenalidomide Remedy Information for necessary details about being pregnant, contraception, and blood and sperm donation.
Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements.
Name your physician for medical recommendation about unintended effects. Chances are you’ll report unintended effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You might also report unintended effects to MORPHOSYS US INC. at (844) 667-1992.
Please see the total Prescribing Info for MONJUVI, together with Affected person Info, for added Vital Security Info.
About Diffuse Giant B-cell Lymphoma (DLBCL)
DLBCL is the commonest kind of non-Hodgkin lymphoma in adults worldwide, characterised by quickly rising lots of malignant B-cells within the lymph nodes, spleen, liver, bone marrow or different organs. It’s an aggressive illness with about 40% of sufferers not responding to preliminary remedy or relapsing thereafter, resulting in a excessive medical want for brand new, efficient therapies, particularly for sufferers who are usually not eligible for an autologous stem cell transplant on this setting.
About entranceMIND
The frontMIND (NCT04824092) trial is a randomized, double-blind, placebo-controlled, world Section 3 medical research in beforehand untreated high-intermediate and high-risk DLBCL sufferers that’s carried out in partnership with the German Lymphoma Affiliation (GLA), the Italian Lymphoma research group and the US Oncology Community. The research enrolled greater than 880 DLBCL sufferers to obtain both tafasitamab plus lenalidomide along with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-CHOP alone. The first endpoint is investigator-assessed progression-free survival, based on Lugano 2014 standards, and key secondary endpoints embrace event-free survival by investigator, total survival, metabolic full response charge by a Blinded Impartial Evaluation Committee, and total response charge.
About MorphoSys
At MorphoSys, we’re pushed by our mission: Extra life for individuals with most cancers. As a worldwide commercial-stage biopharmaceutical firm, we develop and ship revolutionary medicines to sufferers, aspiring to redefine how most cancers is handled. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To study extra, go to us at www.morphosys.com and observe us on Twitter and LinkedIn.
Ahead Trying Statements
This communication incorporates sure forward-looking statements regarding the MorphoSys group of corporations. The forward-looking statements contained herein signify the judgment of MorphoSys as of the date of this launch and contain recognized and unknown dangers and uncertainties, which could trigger the precise outcomes, monetary situation and liquidity, efficiency or achievements of MorphoSys, or trade outcomes, to be materially totally different from any historic or future outcomes, monetary circumstances and liquidity, efficiency or achievements expressed or implied by such forward-looking statements. As well as, even when MorphoSys’ outcomes, efficiency, monetary situation and liquidity, and the event of the trade during which it operates are per such forward-looking statements, they might not be predictive of outcomes or developments in future intervals. Among the many elements which will lead to variations are that MorphoSys’ expectations could also be incorrect, the inherent uncertainties related to aggressive developments, medical trial and product improvement actions and regulatory approval necessities, MorphoSys’ reliance on collaborations with third events, estimating the industrial potential of its improvement packages and different dangers indicated within the threat elements included in MorphoSys’ Annual Report on Kind 20-F and different filings with the U.S. Securities and Trade Fee. Given these uncertainties, the reader is suggested to not place any undue reliance on such forward-looking statements. These forward-looking statements communicate solely as of the date of publication of this doc. MorphoSys expressly disclaims any obligation to replace any such forward-looking statements on this doc to replicate any change in its expectations with regard thereto or any change in occasions, circumstances or circumstances on which any such assertion relies or which will have an effect on the chance that precise outcomes will differ from these set forth within the forward-looking statements, until particularly required by legislation or regulation.
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