This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
Confirmed diagnosis of high-risk ET.
Presence of mutCALR.
Prior treatment with at least 1 cytoreductive therapy.
Presence of any hematologic malignancy other than ET.
Major bleeding or thrombosis within the last 3 months prior to study enrollment.
Any prior allogenic or autologous stem-cell transplantation.
Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
Parallel
INCA033989
DrugAdministered intravenous (IV) in accordance with the protocol-defined requirements.
Best Available Treatment
DrugBest Available Therapy (BAT) will be selected by the investigator.
Durable clinicohematologic response (DCR)
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Reduction from baseline in calreticulin exon 9 frameshift mutation(s) (mutCLAR) variant allele frequency (VAF)
Reduction in mutCALR VAF as defined in the protocol.
Durable clinicohematologic response (DCR)
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Durable partial clinicohematologic response (DPR)
Improvement of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Durable partial clinicohematologic response (DPR)
Improvement of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
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