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Phase 3 Luspatercept Trial

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BabyRiya:
Friends
If everything comes out good, will it open doors for kids/infants? Or it's limited to adult only?

sofear:
Is it really going to take as long as the 2020's or something until Luspatercept will be available? That's a damn long time.

Andy Battaglia:
The phase 3 trials will answer a lot of questions. I think it will be available to children once approved.

Parin:
Acceleron and Celgene Announce Updated Results from Phase 2 Studies of Luspatercept in Beta-Thalassemia Presented at the 58th Annual Meeting of the American Society of Hematology

"Beta-thalassemia is a severe, chronic disease with no pharmaceutical treatment options to correct or improve the underlying anemia in patients," said Michael Pehl, President, Hematology and Oncology for Celgene. "These longer term luspatercept Phase 2 data are encouraging, and we are continuing to enroll patients in the Phase 3 BELIEVE study in transfusion dependent beta-thalassemia patients."

Luspatercept Beta-Thalassemia Data Presented at ASH

Results in Transfusion Dependent (TD) Beta-Thalassemia Patients

    
RBC transfusion reduction
over any 12 weeks versus 12
weeks pre-treatment
        Response rate (% of patients)
            3-month base study
(n=31)
        Long-term extension study
(n=24)
    ≥ 20%           81% (25/31)           96% (23/24)
    ≥ 33%           71% (22/31)           83% (20/24)
    ≥ 50%           55% (17/31)           71% (17/24)
               
Results in Non-Transfusion Dependent (NTD) Beta-Thalassemia Patients

    
Hemoglobin (Hb) response over
any 12 weeks versus 12 weeks
pre-treatment
        Response rate (% of patients)
in patients treated with ≥ 0.6 mg/kg
            3-month base study
(n=21)
        Long-term extension study
(n=27)
    Increase in mean Hb ≥ 1.0 g/dL           62% (14/21)           78% (21/27)
    Increase in mean Hb ≥ 1.5 g/dL           33% (7/21)           52% (14/27)
               
In the long-term extension study, the median duration of a hemoglobin increase ≥ 1.0 g/dL maintained for at least 12 weeks in responders is 13.5 months (N=21) with treatment still ongoing.

Hafiz Akhtar:
for how long phase 3 wi
ll continue. Andy Sir what will u suggest the tentative time for its approval.

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