Genta Plans Genasense Confirmatory Trial In Treatment-Naive Patients
This article was originally published in The Pink Sheet Daily
Executive Summary
With approval possible in June for relapsed or refractory leukemia, Genta is seeking a marketing partner for oblimersen.
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Genta hopes to be able to use its confirmatory trial for Genasense to expand the patient population of the leukemia agent to treatment-naive patients. Genta expects priority review of its NDA for Genasense (oblimersen injection) in patients with relapsed or refractory chronic lymphocytic leukemia, which would give it a user fee date in late June (1 (Also see "Genasense Gets Second Chance As Genta Completes Chronic Leukemia NDA" - Pink Sheet, 29 Dec, 2005.)). The firm is currently seeking a marketing partner for Genasense, CEO Raymond Warrell said during a Jan. 4 conference call. The CLL 241-patient pivotal trial met its primary endpoint of effective induction of complete remission in multiple relapsed patients treated with Genasense and chemotherapy, compared with patients receiving chemotherapy alone, Warrell said. However, Warrell acknowledged, "time to progression is not significantly different" between the two arms. Although complete or nodular partial response rates in both trial arms exceeded the six-month minimum duration, "extended follow-up...has shown that the duration of CR/nPR was significantly longer in patients treated with Genasense," the firm said Dec. 29. Genta has already submitted its confirmatory trial proposal to FDA. The trial will examine Genasense in combination with fludarabine and Genentech/Biogen Idec's Rituxan (rituximab) in treatment-naive patients. "If this trial proves to be positive, and FDA and sponsors have agreed, we would like to use the results of this trial to expand the label to previously untreated patients with CLL," Warrell explained. Warrell, however, noted that using rituximab as part of the comparator drug combination would be a "bit of a stretch," as it is not indicated for treatment of CLL. "This has been an issue for other companies trying to do randomized exploratory trials for CLL," he said. Genta submitted a European marketing authorization application on Jan. 3 for use of Genasense to treat melanoma. The firm withdrew a U.S. application for the same indication in 2004 after a negative FDA advisory committee review. The data submitted to the European Medicines Agency reflects 24 months of minimum follow-up demonstrating a positive pattern in all parameters. In comparison, the U.S. melanoma submission had included six months of data, Warrell said. Genta said it plans to resume discussions with FDA regarding the melanoma indication after Genasense is approved for CLL. -Kathryn Phelps |