Mantle Cell Lymphoma

July 22, 2013

Pharmacyclics reported results from a phase II trial of ibrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL). The phase II, open-label, multi-center study enrolled 111 patients internationally; 86% had intermediate or high-risk MCL and had previously undergone treatment with a median of three prior therapies before enrollment in the study. Participants received a 560mg daily oral dose of ibrutinib monotherapy and were treated in two cohorts based on prior exposure to bortezomib—either no prior bortezomib (n=63) or prior bortezomib (n=48). Overall response rate across both cohorts was 68%, with 47% of patients achieving a partial response and 21% achieving a complete response in which all signs of cancer are gone. The estimated median response duration was 17.5 months. The median progression-free survival was 13.9 months and while the median overall survival for this study has not yet been reached, it is estimated to be 58% at 18 months.

July 15, 2013

Pharmacyclics reported results from a phase II studies of ibrutinib for the treatment of relapsed/refractory mantle cell lymphoma (MCL). This multicenter, open-label study treated 111 patients with ibrutinib at 18 sites internationally. Patients were divided into two cohorts based on prior bortezomib exposure—either bortezomib-naïve (n=63) or bortezomibexposed (n=48). Both groups received 560mg of ibrutinib orally, once a day until disease progression or until it was no longer tolerated by the patient. There was an overall response rate (ORR) of 68%, including a complete response (CR) of 21% where all signs of cancer are gone, and a partial response (PR) of 47%. The estimated median duration of response (DOR) in all responding patients was 17.5 months. The median progression-free survival (PFS) was 13.9 months.

December 17, 2012

Senesco Technologies released interim results from an ongoing phase Ib/IIa trial of SNS01-T for the treatment of multiple myeloma, mantle cell (MCL) and B-cell lymphoma (DLBCL). This open-label, multiple-dose, dose-escalation study enrolled two patients so far with relapsed or refractory multiple myeloma. Subjects received SNS01-T or 0.0125mg/kg per dose intravenously, while the next three arms will receive SNS01-T or 0.05mg/kg, 0.2mg/kg or 0.375mg/kg per dose intravenously. Blood levels of monoclonal (M)-protein were measured using serum protein electrophoresis. Data showed patients 41-002 and 42-002 in cohort 1, serum levels of M-protein remained within 25% of the baseline values (3.60g/dL, 3.0g/dL respectively) at weeks three (3.90g/dL, 2.8g/dL) and six (4.20g/dL, 2.8g/dL), stable disease. For patient 42-002, M-protein stayed within 25% of baseline at week 10 (3.2g/dL)—four weeks after the end of treatment. M-protein levels for patient 43-001 increased from baseline to week three by 26% and from baseline to week six by 30%. Indicative of the partial disappearance of cancer cells, the plasma cell levels for patients 41-002 and 42-002 declined from 70% to 50% and from 50% to 15%, respectively. Plasma cell levels for patient 43-001 increased from 70% at baseline to 97% at end of treatment. Based on these data, Senesco Technologies will continue to dose patients in the other three arms.

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