Constellation Pharmaceuticals Provides Interim Update of Data for CPI-0610 in ASCO and EHA Abstracts
- Data published in two abstracts suggest that CPI-0610 may have potential disease-modifying effects in treating myelofibrosis
- All ten evaluable patients experienced spleen volume reductions
- Improvements in symptom scores, bone marrow fibrosis, and hemoglobin levels also seen
- Two transfusion dependent patients became transfusion independent
- Additional data based on a more recent data cut will be presented at
ASCOon June 3and EHA on June 15
MANIFEST is an open-label Phase 2 clinical trial of CPI-0610 in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body’s normal production of blood cells. Constellation is evaluating CPI-0610, either as a monotherapy or in combination with ruxolitinib, in a second-line setting in patients with MF who are refractory to or intolerant of or have relapsed or lost response to ruxolitinib. Patients in the two second-line arms are being stratified based on transfusion dependent status. The primary endpoint for the cohorts with transfusion-dependent patients is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for the patients who were non-transfusion dependent at baseline is spleen volume reduction. In addition, the Company added a third arm designed to evaluate treatment with CPI-0610 in combination with ruxolitinib as a first-line therapy in JAK 1/2-inhibitor-naïve MF patients.
Data Highlights From Abstracts
Below are highlights of data on second-line patients in the
- Spleen volume reductions as measured by MRI occurred in all ten evaluable patients and ranged from 6% to 44%.
- Symptom improvements were observed.
- Out of the four patients who received bone marrow assessments, three had a one-grade improvement in bone marrow fibrosis and had hemoglobin increases of ≥1.5 g/dL for ≥12 weeks without transfusions. The fourth patient had a one-grade improvement in the bone marrow reticulin score. All of these score improvements were based on a scale of 0-3.
- Two of the four patients with bone marrow assessments were transfusion dependent at baseline, and both of these patients became transfusion independent.
- Hemoglobin increases of ≥1.5 g/dL occurred in both of two evaluable patients on monotherapy and three of nine patients on the combination with ruxolitinib.
- CPI-0610, both as monotherapy and in combination with ruxolitinib, was generally well tolerated. The most common side effects were Grade 1 / 2 diarrhea, nausea / vomiting, and reversible and non-cumulative thrombocytopenia.
“Interim data from the MANIFEST trial indicate that CPI-0610 has been generally well-tolerated, with promising therapeutic activity for the treatment of myelofibrosis,” said
ASCO Poster Presentation
TITLE: A Phase 2 Study of CPI-0610, a Bromodomain and Extraterminal Protein Inhibitor (BETi) alone or with Ruxolitinib (RUX), in Patients with Myelofibrosis (MF)
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:
EHA Oral Presentation
TITLE: CPI-0610, A Bromodomain and Extraterminal Domain (
Session: New Agents in MPN
Date and Time:
Investor Event. Constellation will also host an investor meeting and conference call to discuss these interim data on
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Senior Director, Investor Relations
MacDougall Biomedical Communications
Source: Constellation Pharmaceuticals