Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7490677 · 1 trial · 3 indications
ORR was defined as the percent of participants with a response according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. This was defined as those participants who achieved clinical improvement (CI), partial remission (PR), or complete remission (CR) at a post-baseline assessment of treatment response OR had at least stable disease (SD) for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease.
Response rate was defined as the percent of participants with a reduction in bone marrow fibrosis by at least one grade according to World Health Organization (WHO) criteria from baseline to any time during the study. This was determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy.
ORR was defined as the percent of participants with a response according to the IWG-MRT criteria. This was defined as those participants who achieved CI, PR, or CR at a post-baseline assessment of treatment response OR had at least SD for three consecutive end-of-cycle response assessments (e.g. Day 1 of the subsequent cycle) in conjunction with improvement in the bone marrow fibrosis score relative to baseline by at least one grade at any time point during the period of stable disease. Participants who achieved a clinical benefit in the main phase had the opportunity to remain on treatment. The determination of ORR in the main phase is outlined in the arms description below. Participants who didn't achieve a benefit had the opportunity to switch to a different dosing schedule in the OLE phase. The determination of ORR in the OLE phase is outlined in the arms descriptions below.
Defined as the percent of participants with a reduction in bone marrow fibrosis score by at least one grade according to WHO criteria at any time during the study. As determined by a central adjudication panel of expert hematopathologists, blinded to participant, treatment, and time of biopsy. Participants in the main phase had the opportunity to remain on treatment (as outlined in the arms description below). Participants also had the option to switch to the OLE phase after completing 9 cycles of the originally assigned treatment and receive PRM-151 10 mg/kg/Q4W (as outlined in the arms description below).
| Arm | Type | Description |
|---|---|---|
| Stage 1: Cohort 1 Weekly | EXPERIMENTAL | Participants who received no treatment for MF in at least two weeks will be assigned to treatment with single agent RO7490677 at a dose of 10 mg/kg IV on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles. |
| Stage 1: Cohort 1 Every 4 Weeks | EXPERIMENTAL | Paricipants who received no treatment for MF in at least two weeks will be assigned to treatment with single agent RO7490677 at a dose of 10 mg/kg administered IV on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles. |
| Stage 1: Cohort 2 Weekly | EXPERIMENTAL | Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks will be assigned to receive RO7490677 in combination with ruxolitinib at a dose of 10 mg/kg administered IV on Days 1, 3, 5, 8, 15, and 22 of Cycle 1 and Days 1, 8, 15 and 22 of each subsequent 28 day cycle for six cycles. |
| Stage 1: Cohort 2 Every 4 Weeks | EXPERIMENTAL | Participants on a stable dose of ruxolitinib for at least 12 weeks, with no improvement in spleen during the last four weeks will be assigned to receive RO7490677 in combination with ruxolitinib at a dose of 10 mg/kg administered IV on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for six cycles. |
| Stage 2: Cohort 1 0.3mg/kg Every 4 Weeks | EXPERIMENTAL | Participants will be treated with single agent RO7490677 at a dose of 0.3 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. |
| Stage 2: Cohort 2 3mg/kg Every 4 Weeks | EXPERIMENTAL | Participants will be treated with single agent RO7490677 at a dose of 3.0 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. |
| Stage 2: Cohort 3 10mg /kg Every 4 Weeks | EXPERIMENTAL | Participants will be treated with single agent RO7490677 at a dose of 10 mg/kg IV administered as a 60 minute intravenous infusion on Days 1, 3, and 5 of Cycle 1 and Day 1 of each subsequent 28 day cycle for nine cycles. |
| Name | Type | Description |
|---|---|---|
| RO7490677 | BIOLOGICAL | IV infusion |
| Ruxolitinib | DRUG | IV infusion |
Inclusion Criteria: 1. Participants must be ≥18 years of age at the time of signing the Informed Consent Form (ICF); 2. Participants must voluntarily sign an ICF; 3. Participants must have a pathologically confirmed diagnosis of PMF as per the WHO diagnostic criteria or post ET/PV MF; 4. At least G...
RO7490677 is an investigational monoclonal antibody being studied for the treatment of primary myelofibrosis, a type of bone marrow disorder. It is also being evaluated in related conditions including polycythemia vera and post-essential thrombocythemia myelofibrosis. The drug is currently in Phase 2 clinical development.
RO7490677 is being developed by Roche Holding AG, a multinational healthcare company. Roche is listed on the stock exchange under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for myelofibrosis.
RO7490677 is in Phase 2 clinical development. A Phase 2 study has been completed to evaluate the drug in participants with myelofibrosis. The drug is still investigational and has not been approved by regulatory authorities for commercial use.
RO7490677 has been studied in a Phase 2 clinical trial registered as NCT01981850. This completed study enrolled 125 participants with primary myelofibrosis, polycythemia vera, and post-essential thrombocythemia myelofibrosis. The trial was conducted in the United States, Canada, France, Germany, Israel, Italy, Netherlands, and the United Kingdom.
Yes, the Phase 2 clinical trial of RO7490677 was a randomized, double-blind, controlled study. This design helps reduce bias by randomly assigning participants to treatment groups and keeping both participants and investigators unaware of which treatment was administered.
RO7490677 is a monoclonal antibody, a type of biologic therapy that targets specific proteins involved in disease processes. In the context of myelofibrosis, it is being investigated for its potential to interfere with disease-related signaling pathways, though the specific molecular target has not been disclosed.