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News from the Field

Posted By Connections Editor, Friday, November 6, 2015
Updated: Thursday, November 5, 2015
Kite Pharma Provides Update on KTE-C19 Clinical Trial
Kite Pharma, Inc. provided an update from the company’s ongoing Phase I/II clinical trial of KTE-C19 in patients with refractory aggressive non-Hodgkin’s lymphoma who have failed prior chemotherapy treatments and have a poor prognosis. There was one patient death early in the study, which was determined to be unrelated to KTE-C19 by the study investigator.

Gamida Cell Achieves Major Regulatory Milestone: FDA and EMA Respond Positively to NiCord® Phase III Study Design Outline
Gamida Cell announced that the company has reached agreements with the FDA and EMA regarding the Phase III study design outline of NiCord. The company is moving forward now with plans to commence an international, multi-center, Phase III study of NiCord in 2016. . Phase I/II data of 15 patients are expected in Q4/2015.

Phase II Study of Venetoclax in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia with 17p Deletion Meets Primary Endpoint
AbbVie announced that a Phase II trial of its investigational medicine venetoclax met its primary endpoint of achieving overall response rates in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia with 17p deletion, according to an independent review analysis.

Kiadis Pharma Announces Full Enrollment of Its Phase II Clinical Study with Lead Product, ATIR101™
Kiadis Pharma N.V. announced full enrollment of patients into its ongoing Phase II clinical study with its lead product, ATIR101™. ATIR101™ is a cell-based product designed to enable stem cell transplantations from partially matched family donors for blood cancer patients who do not have a matching stem cell donor available.

Seattle Genetics Completes Enrollment in Phase III ALCANZA Clinical Trial Evaluating ADCETRIS® (Brentuximab Vedotin) in CD30-Expressing Cutaneous T-Cell Lymphoma (CTCL)
Seattle Genetics, Inc. announced that the company and its collaborator, Takeda Pharmaceutical Company Limited, completed patient enrollment in the Phase III ALCANZA clinical trial. ALCANZA is a randomized trial evaluating ADCETRIS versus investigator’s choice of methotrexate or bexarotene in 132 patients with CD30-expressing CTCL who received prior systemic therapy.

Avillion Announces Completion of Enrolment in Phase III BFORE Trial to Assess BOSULIF® (Bosutinib) as First-Line Treatment for Patients with Chronic Myelogenous Leukemia
Avillion LLP announced the completion of enrollment in a global Phase III clinical trial called “BFORE,” which is designed to assess the effectiveness and safety of BOSULIF® (bosutinib) as a first-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia.

Amgen Receives CHMP Positive Opinions for Two New Treatment Options for Patients with Blood Cancer in Europe
Amgen announced that the Committee for Medicinal Products (CHMP) for Human Use of the European Medicines Agency adopted positive opinions recommending marketing authorization for Kyprolis®® (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma and BLINCYTO® (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia.

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