Duyuru • Dec 11

MorphoSys AG’ Pelabresib Improves All Four Hallmarks of Myelofibrosis in Phase 3 MANIFEST-2 Study

MorphoSys AG announced comprehensive results from the Phase 3 MANIFEST-2 study investigating pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis. These findings were presented in an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California. Myelofibrosis is characterized by four hallmarks: an enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms. In MANIFEST-2, all hallmarks were improved with the pelabresib and ruxolitinib combination versus placebo plus ruxolitinib, which is the standard of care in myelofibrosis. Ruxolitinib dosing was similar in both arms of the study and was determined based on its approved myelofibrosis indication. MANIFEST-2 Comprehensive Findings: MANIFEST-2 is a global, multicenter, double-blind, Phase 3 study of 430 JAK inhibitor-naïve adults with myelofibrosis, randomized 1:1 to receive the pelabresib and ruxolitinib combination or placebo plus ruxolitinib. MANIFEST-2 is one of the largest studies in this disease to date. Strong Reductions in Spleen Size and Symptoms: In the MANIFEST-2 study, pelabresib and ruxolitinib demonstrated a near doubling in the proportion of patients achieving a =35% reduction in spleen volume (SVR35) at 24 weeks, the primary endpoint, versus placebo plus ruxolitinib (p<0.001). For the first key secondary endpoint assessing symptom reduction, absolute change in total symptom score (TSS) at 24 weeks, there was a strong numerical improvement for patients receiving pelabresib and ruxolitinib versus placebo plus ruxolitinib. The response rate for the second key secondary endpoint, proportion of patients achieving =50% reduction in symptom score (TSS50) at 24 weeks, was also numerically greater for patients receiving pelabresib and ruxolitinib. Significant improvements in both key secondary endpoints were observed with the pelabresib combination for patients classified as intermediate-risk (Dynamic International Prognostic Scoring System [DIPSS] Int-1 and Int-2), who account for over 90% of the MANIFEST-2 population. The proportion of patients achieving both SVR35 and TSS50 at 24 weeks was doubled with pelabresib and ruxolitinib versus placebo plus ruxolitinib (40.2% vs. 18.5%, respectively). Improvement in Anemia: Patients receiving pelabresib in combination with ruxolitinib reported fewer anemia adverse events (43.9%, grade =3: 23.1%) compared with placebo plus ruxolitinib (55.6%, grade =3: 36.4%). Additionally, by week 24, fewer patients in the pelabresib and ruxolitinib arm required red blood cell transfusions compared with the placebo arm (30.8% vs. 41.2%, respectively). A greater proportion of patients achieved a hemoglobin response — defined as a =1.5 g/dL mean increase in hemoglobin levels over baseline in the absence of transfusions during the previous 12 weeks — with pelabresib and ruxolitinib versus placebo plus ruxolitinib (9.3% vs. 5.6%, respectively). Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24. Anemia benefits were observed across all studied patient risk groups. Improvement in Bone Marrow Fibrosis: Bone marrow fibrosis, or the replacement of bone marrow with fibrous scar tissue, is a central pathological feature of myelofibrosis. In MANIFEST-2, fibrosis was improved by at least one grade in a greater proportion of patients receiving pelabresib and ruxolitinib (38.5% vs. 24.2% with placebo plus ruxolitinib) and worsened by at least one grade in a smaller proportion of patients receiving pelabresib and ruxolitinib (16.3% vs. 28.3% with placebo plus ruxolitinib) at 24 weeks. Bone marrow fibrosis is graded on a scale from 0 (normal) to 3 (most severe) based on fiber density; studies suggest a correlation between the grade of bone marrow fibrosis and patient prognosis. Biomarker Analysis Suggests Disease Modification: In a biomarker analysis, average plasma levels of inflammatory cytokines (IL-8, IL-6, TNF-a and NF-?B-regulated cytokines) were reduced in patients receiving pelabresib and ruxolitinib compared with placebo plus ruxolitinib at 24 weeks. Increased cytokine levels are associated with all four disease hallmarks; increased IL-8 levels are also associated with worse survival outcomes. These biomolecular improvements suggest early evidence of a disease-modifying effect. Well-Tolerated Safety Profile: Overall, grade =3 treatment-emergent adverse events (TEAEs) were reported less frequently with pelabresib and ruxolitinib than with placebo plus ruxolitinib (49.1% vs. 57.5%, respectively). In the pelabresib and ruxolitinib arm, the most common (=10%) hematologic TEAEs were anemia (43.9%; grade =3: 23.1%), thrombocytopenia (32.1%; grade =3: 9.0%) and platelet count decrease (20.8%; grade =3: 4.2%). In the placebo plus ruxolitinib arm, the most common hematologic TEAEs were anemia (55.6%; grade =3: 36.4%), thrombocytopenia (23.4%; grade =3: 5.6%) and platelet count decrease (15.9%; grade =3: 0.9%). The most common (=10%) nonhematologic TEAEs in the pelabresib and ruxolitinib arm were diarrhea (23.1%; grade =3: 0.5%), dysgeusia (18.4%; grade =3: 0.5%), constipation (18.4%; grade =3: 0%), nausea (14.2%; grade =3: 0.5%), cough (12.7% grade =3: 0), asthenia (11.8% grade =3: 0.5%), fatigue (11.8%; grade =3: 0.5%), dizziness (11.3%; grade =3: 0%), headache (11.3% grade =3: 0.5%) and COVID-19 (11.3%; grade =3: 0%). The most common nonhematologic TEAEs in the placebo plus ruxolitinib arm were constipation (24.3%; grade =3: 0%), diarrhea (18.7%; grade =3: 1.4%), fatigue (16.8%; grade =3: 0.9%), COVID-19 (15.9%; grade =3: 1.9%), nausea (15.0%; grade =3: 0%), asthenia (13.6%; grade =3: 0%), dyspnea (13.1%; grade =3: 0.9%), cough (11.2%; grade =3: 0%) and headache (10.7%; grade =3: 0%). Discontinuation rates due to adverse events were 10.7% with pelabresib and ruxolitinib and 6.5% with placebo plus ruxolitinib. The safety profile of the pelabresib and ruxolitinib combination therapy was consistent with previous clinical studies. No new safety signals were observed.

Duyuru • Nov 03

MorphoSys AG to Showcase Phase 3 MANIFEST-2 Data on Pelabresib in Myelofibrosis in Oral Presentation at 2023 ASH Annual Meeting

MorphoSys AG announced 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) Annual Meeting and Exposition. The conference is being held in San Diego, California, from December 9 to 12, 2023. 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. Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been approved by any regulatory authorities. Its safety and efficacy have also not been established in a pivotal trial. MANIFEST is an open-label Phase 2 clinical trial of pelabresib in patients with myelofibrosis and high-risk essential thrombocythemia. The MANIFEST trial is evaluating pelabresib in combination with ruxolitinib in JAK-inhibitor-naïve myelofibrosis patients (Arm 3), with a primary endpoint of the proportion of patients with a =35% spleen volume reduction from baseline (SVR35) after 24 weeks of treatment. The trial is also evaluating pelabresib either as a monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib and no longer on the drug (Arm 1) or as add-on therapy in combination with ruxolitinib in patients with a suboptimal response to ruxolitinib or myelofibrosis progression (Arm 2). Patients in Arms 1 and 2 are being stratified based on transfusion-dependent (TD) status. The primary endpoint for the patients in cohorts 1A and 2A, who were TD at baseline, is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for patients in cohorts 1B and 2B, who were not TD at baseline, is the proportion of patients with a =35% spleen volume reduction from baseline after 24 weeks of treatment. The study is also evaluating pelabresib as a monotherapy in patients with high-risk essential thrombocythemia who are intolerant of, or refractory to, hydroxyurea (Arm 4). The primary endpoint for patients in Arm 4 is complete hematological response rate after one cycle, or 21 days, of treatment. Constellation Pharmaceuticals Inc., a MorphoSys company, is the MANIFEST trial sponsor. Myelofibrosis, which belongs to a group of diseases called myeloproliferative disorders, is a difficult-to-treat form of blood cancer that's characterized by bone marrow fibrosis (a buildup of scar tissue in the bone marrow), spleen enlargement and anemia (low red blood cell counts) often requiring periodic blood transfusions. Patients with myelofibrosis can also suffer from a range of physical symptoms, including severe fatigue, night sweats, itching, increased bleeding and significant pain caused by their enlarged spleen. For many living with myelofibrosis, the combination of symptoms often severely impacts their quality of life. At diagnosis, several factors, such as age, genetics and bloodwork, help determine a patient's long-term prognosis. About 90% of newly diagnosed patients have intermediate- to high-risk disease, which has a worse prognosis and a higher likelihood of disease-associated symptoms. Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). The most common side effects of MONJUVI include: Feeling tired or weak, Diarrhea, Cough, Fever, Swelling of lower legs or hands, Respiratory tract infection and Decreased appetite.

Faiz karşılama oranı	n/a
Nakit	€630.77m
Eşitlik	-€261.67m
Toplam yükümlülükler	€2.09b
Toplam varlıklar	€1.83b

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2024/08/05 19:39
Gün Sonu Hisse Fiyatı	2024/08/05 00:00
Kazançlar	2024/03/31
Yıllık Kazançlar	2023/12/31

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Analist	Kurum
Olav Zilian	Baader Helvea Equity Research
Brian Balchin	Barclays
Rosie Turner	Barclays

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