Infinity Pharmaceuticals, Inc. – News Release

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IPI-145 Data in Patients with CLL The presentation, “Preliminary safety and efficacy of IPI-145, a potent inhibitor of phosphoinositide-3-kinase-δ,γ, in patients with chronic lymphocytic leukemia” (Abstract #677), included 67 patients evaluable for safety and 47 evaluable for clinical activity. Among the 67 patients enrolled in the study, 52 had advanced disease and had progressed during or were refractory to, intolerant of, or ineligible for established therapy. An additional 15 treatment-naïve patients were enrolled who were age 65 or over or high-risk, defined as having 17p deletions or p53 mutations.Clinical ActivityUpdated data from the ongoing Phase 1 study showed that IPI-145 is clinically active in patients with relapsed/refractory CLL. Treatment with IPI-145 at doses ≤ 25 mg BID in patients with relapsed/refractory CLL led to a nodal response rate of 89 percent and an overall response rate of 48 percent as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria1, including one complete response and 12 partial responses among 27 patients evaluable for response. The median time to response was less than two months. Seventy-five percent of patients (six of eight) treated for 12 months or longer remain progression-free on treatment.Among 12 patients evaluable with 17p deletions or p53 mutations who received IPI-145 at doses ≤ 25 mg BID, there were six partial responses, five patients with stable disease, and one disease progression due to Richter transformation. Patients with CLL with 17p deletions or p53 mutations generally have a poor response to chemotherapy and worse prognosis.2 Preliminary data in treatment-naïve patients showed a reduction in adenopathy in all six patients. Three of these six patients had nodal responses, including nodal responses in two patients with p53 mutations.


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