MorphoSys AG : MorphoSys Completes Enrollment of Part 3 MANIFEST-2 Examine of Pelabresib in Myelofibrosis with Topline Outcomes Anticipated by Finish of 2023

Media Launch

Planegg/Munich, Germany, April 4, 2023
 

MorphoSys Completes Enrollment of Part 3 MANIFEST-2 Examine of Pelabresib in Myelofibrosis with Topline Outcomes Anticipated by Finish of 2023

Enrollment of Part 3 frontMIND research of tafasitamab in first-line diffuse giant B-cell lymphoma can also be full

MorphoSys AG (FSE: MOR; NASDAQ: MOR) introduced right now that enrollment is full for MANIFEST-2, the continuing Part 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-naïve). The topline knowledge at the moment are anticipated by the tip of 2023, sooner than beforehand anticipated.

Myelofibrosis – which belongs to a gaggle of ailments known as myeloproliferative issues – is a difficult-to-treat type of blood most cancers with restricted remedy choices. JAK inhibitors are a present customary of care remedy for myelofibrosis, which give attention to relieving signs of the illness reasonably than treating its trigger. However, with this remedy technique, solely about half of sufferers attain satisfactory illness management, and sturdiness of response is usually 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 important 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 sit up for the approaching insights into the therapeutic potential of pelabresib together with ruxolitinib for JAK inhibitor-naïve 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 group.”

MANIFEST-2 is a worldwide, multicenter, double-blind, Part 3 research of greater than 400 sufferers who had been naïve to JAK inhibitors. Sufferers had 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 larger discount in spleen quantity at week 24 (often called SVR35). Discount in spleen dimension is a vital scientific endpoint in myelofibrosis as a result of spleen enlargement displays illness exercise and might trigger vital ache and discomfort.

The important thing secondary endpoint is the proportion of sufferers attaining a 50% or larger 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 attributable to signs akin to extreme fatigue, fever and weight reduction. The Myelofibrosis Symptom Evaluation Kind is a validated self-assessment software designed particularly for myelofibrosis sufferers that may observe modifications in these signs.

The MANIFEST-2 trial is supported by findings from the Part 2 MANIFEST trial of pelabresib together with ruxolitinib in sufferers with myelofibrosis, together with those that had been JAK inhibitor-naïve. Up to date outcomes from MANIFEST introduced on the American Society of Hematology 2022 Annual Assembly and Exposition recommend that pelabresib together with ruxolitinib offered extended enchancment in each spleen dimension and symptom severity at and past 24 weeks.

Enrollment of the Part 3 frontMIND research can also be full, with greater than 880 sufferers enrolled within the trial. frontMIND is a worldwide, multicenter, randomized, double-blind, placebo-controlled trial exploring tafasitamab, marketed within the U.S. as Monjuvi® and outdoors 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 operate 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 accepted by any regulatory authorities. 

About Myelofibrosis

Myelofibrosis – one in all a gaggle of ailments known as myeloproliferative issues – is a difficult-to-treat type of blood most cancers that’s characterised by bone marrow fibrosis (a buildup of scar tissue within the bone marrow), spleen enlargement and anemia (low pink blood cell counts) usually requiring periodic blood transfusions. Sufferers with myelofibrosis can even endure from a spread of bodily signs, together with extreme fatigue, evening sweats, itching, elevated bleeding and vital ache brought on by their enlarged spleen. For a lot of dwelling with myelofibrosis, the mix of signs usually severely impacts their high quality of life. At prognosis, a number of elements, akin to age, genetics and bloodwork, assist decide a affected person’s long-term prognosis. About 90% of newly identified sufferers have intermediate- to high-risk illness, which has a worse prognosis and a better chance of disease-associated signs. At the moment, myelofibrosis remedies revolve round the usage of medicines known as JAK inhibitors, which give attention to relieving signs of myelofibrosis reasonably than treating its trigger. However with this technique, solely about 50% of sufferers obtain satisfactory symptom management, and, sadly, that aid fades with time for a lot of. Sufferers affected by myelofibrosis are in important want of remedy choices that not solely handle their signs but additionally change the general course of their illness.

About MANIFEST-2  

MANIFEST-2 (NCT04603495) is a worldwide, double-blind, randomized Part 3 scientific trial with pelabresib together with ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-naïve sufferers with myelofibrosis. The first endpoint of the research is a 35% or larger discount in spleen quantity (SVR35) from baseline at 24 weeks. The important thing secondary endpoint of the research is a 50% or larger 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 Part 2 scientific trial of pelabresib in sufferers with myelofibrosis. The MANIFEST trial is evaluating pelabresib together with ruxolitinib in JAK-inhibitor-naïve 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 also be evaluating pelabresib both as a monotherapy in sufferers who’re immune to, illiberal of, or ineligible for ruxolitinib and 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 pair of are being stratified based mostly on transfusion-dependent (TD) standing. The first endpoint for the sufferers in cohorts 1A and 2A, who had 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 means of apoptosis and immune effector mechanism together with Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Mobile Phagocytosis (ADCP). 

In the US, Monjuvi® (tafasitamab-cxix) is accepted 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 will not be eligible for autologous stem cell transplant (ASCT). This indication is accepted below accelerated approval based mostly on total response price. Continued approval for this indication could also be contingent upon verification and outline of scientific 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 will not be 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 below the model title Monjuvi® within the U.S., and marketed by Incyte below the model title Minjuvi® in Europe and Canada. 

XmAb® is a registered trademark of Xencor, Inc. 

Vital Security Data

What are the attainable negative effects of MONJUVI?
MONJUVI might trigger severe negative effects, together with:

– Infusion reactions. Your healthcare supplier will monitor you for infusion reactions throughout your infusion of MONJUVI. Inform your healthcare supplier straight away should 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 straight away should 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 dying, have occurred in individuals throughout remedies with MONJUVI and after the final dose. Inform your healthcare supplier straight away should you get a fever of 100.4 F (38 C) or above, or develop any indicators and signs of an an infection.

The most typical negative effects of MONJUVI embody:

– Feeling drained or weak

– Diarrhea

– Cough

– Fever

– Swelling of decrease legs or fingers

– Respiratory tract an infection

– Decreased urge for food

These will not be all of the attainable negative effects of MONJUVI.
Name your physician for medical recommendation about negative effects. You might report negative effects to FDA at 1-800-FDA-1088.

Earlier than you obtain MONJUVI, inform your healthcare supplier about all of your medical situations, together with should you:

– Have an energetic 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 in case you are pregnant as a result of lenalidomide could cause start defects and dying of your unborn child.

     – It is best to use an efficient methodology of contraception (contraception) throughout remedy and for at the very least 3 months after your closing dose of MONJUVI.

    – Inform your healthcare supplier straight away should you grow to be pregnant or suppose that you could be be pregnant throughout remedy with MONJUVI.

    – Are breastfeeding or plan to breastfeed. It isn’t identified if MONJUVI passes into your breastmilk. Don’t breastfeed throughout remedy for at the very least 3 months after your final dose of MONJUVI.

You also needs to learn the lenalidomide Treatment 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 negative effects. You might report negative effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may additionally report negative effects to MORPHOSYS US INC. at (844) 667-1992.

Please see the total Prescribing Data for MONJUVI, together with Affected person Data, for added Vital Security Data.

About Diffuse Giant B-cell Lymphoma (DLBCL)

DLBCL is the commonest sort of non-Hodgkin lymphoma in adults worldwide, characterised by quickly rising plenty 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 spanking new, efficient therapies, particularly for sufferers who will not be eligible for an autologous stem cell transplant on this setting.

About frontMIND

The frontMIND (NCT04824092) trial is a randomized, double-blind, placebo-controlled, international Part 3 scientific 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 embody event-free survival by investigator, total survival, metabolic full response price by a Blinded Impartial Overview Committee, and total response price.

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 progressive 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 Wanting Statements

This communication accommodates sure forward-looking statements regarding the MorphoSys group of firms. The forward-looking statements contained herein symbolize the judgment of MorphoSys as of the date of this launch and contain identified and unknown dangers and uncertainties, which could trigger the precise outcomes, monetary situation and liquidity, efficiency or achievements of MorphoSys, or business outcomes, to be materially totally different from any historic or future outcomes, monetary situations 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 business wherein it operates are in line with such forward-looking statements, they might not be predictive of outcomes or developments in future intervals. Among the many elements which will end in variations are that MorphoSys’ expectations could also be incorrect, the inherent uncertainties related to aggressive developments, scientific trial and product growth actions and regulatory approval necessities, MorphoSys’ reliance on collaborations with third events, estimating the business potential of its growth applications and different dangers indicated within the danger elements included in MorphoSys’ Annual Report on Kind 20-F and different filings with the U.S. Securities and Alternate Fee. Given these uncertainties, the reader is suggested to not place any undue reliance on such forward-looking statements. These forward-looking statements converse 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 mirror any change in its expectations with regard thereto or any change in occasions, situations 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 regulation or regulation.

For extra info, please contact: