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|New Interim Phase 2a Study Results Demonstrate Broad Clinical Activity of Portola Pharmaceuticals’ Oral SYK/JAK Inhibitor Cerdulatinib|
– Differentiated SYK-JAK Inhibitor Shows Efficacy in Patients with Heavily Pre-Treated B- and T-Cell Malignancies –
– New Signal in AITL; Five Complete Responses for a Complete Response Rate of 71 Percent –
– Data to be Presented
Among the 114 patients enrolled across five cohorts, 101 were evaluable as of
Seven of the 20 patients in the PTCL cohort achieved a complete response (CR), including:
Five of the seven responding PTCL patients remain on study drug, including one at 12+ months and one at 9+ months. Of the remaining two patients, one received a bone marrow transplant after achieving CR and one discontinued due to Grade 3 colitis. All patients were previously on at least three prior therapies, including belinostat, pralatrexate and romidepsin. Additionally, data demonstrate an initial signal in CTCL, with the first patient enrolled achieving a CR.
Cerdulatinib also showed consistent activity among the 35 patients with FL, with an ORR of 46 percent and a median duration of response of eight months or more. Among the 28 patients with CLL/SLL, the ORR was 61 percent. All patients in these cohorts were previously on at least three prior therapies.
Cerdulatinib was generally well-tolerated. The most common serious adverse events occurring in ≥10 percent of patients were: lipase increase (18 percent), neutropenia (17 percent) and pneumonia/lung infection (11 percent). Additionally, five deaths due to sepsis or septic shock (three of which were concomitant with pneumonia) were considered related to study drug. These occurred primarily in patients with CLL/SLL.
“Cerdulatinib continues to demonstrate promising results across a wide range of B- and T-cell malignancies, including early indications of the potential for durable responses,” said Dr. Hamlin. “The new signals in relapsed/refractory PTCL and CTCL are particularly compelling when you consider the limited treatment options for patients that fail front-line therapy. I am encouraged by these data and the potential of cerdulatinib to provide a significant clinical benefit to a group of patients with limited treatment options.”
“These interim results provide evidence for cerdulatinib’s unique mechanism of action of possibly disrupting two key cell signaling pathways, and its potential to control relapsed/refractory B-cell and T-cell malignancies in combination with standard and investigational therapies,” said
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Cerdulatinib is being developed to treat patients with follicular lymphoma (FL), PTCL and other hematologic cancers, specifically those who have relapsed or who have not responded to prior therapies.
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