What we already know: Top-line results from the phase III kidney cancer study of tivozanib were announced in early January with tivozanib demonstrating a progression-free survival of 11.9 months compared to 9.1 months for Onyx's Nexavar. In a subset of treatment-naive patients (70% of patients enrolled in the trial), tivozanib PFS was 12.7 months versus 9.1 months for Nexavar. Both results were statistically significant.
What's new in the ASCO abstract: Nexavar performed better than expected in the study, which narrowed the benefit shown by tivozanib and caused some investors to question the tivozanib's true efficacy. Aveo asserts tivozanib's safety data demonstrates superiority over Nexavar.
In the ASCO abstract (No. 4501) released Wednesday, serious hypertension (grade 3 or higher) was reported in 26% of tivozanib patients compared to 18% of Nexavar patients. Serious hand-foot syndrome was reported in 2% of tivozanib patients versus 17% of Nexavar patients. Reported rates of serious diarrhea, fatigue and neutropenia were similar between tivozanib and Nexavar.Aveo announced additional safety analyses Wednesday outside what's contained in the ASCO abstract: Rate of dose interruptions due to adverse events was 18% for tivozanib compared to 35% for Nexavar; the rate of dose reductions in the study was 14% for tivozanib compared to 44% for Nexavar. Seattle Genetics What we already know: Seattle Genetics is in the early stages of launching Adcetris for two different types of lymphomas -- Hodgkin's lymphoma and anaplastic large cell lymphoma. At ASCO this year, Seattle Genetic will be presenting new data seeking to expand Adcetris' use in lymphoma and non-lymphomas. What's new in the ASCO abstracts: Abstract No. 8027 reports on a phase II Adcetris "retreatment" trial in which HL and ALCL patients who previously responded to treatment with Adcetris are retreated with the drug when their cancer relapses. Like Roche's Rituxan, which can be used multiple times in the same patients, Seattle Genetics wants to eventually expand the Adcetris label to allow for retreatment. According to interim results in the abstract, objective responses were reported in 13 of 20 (65%) of evaluable patients undergoing Adcetris retreatment. Of 11 patients with pre-existing peripheral neuropathy, 3 (27%) had worsening with retreatment. Abstract No. 8070 reports on a phase II study of Adcetris in patients with various types of non-Hodgkin lymphoma. Ten patients enrolled in the study to date, with six evaluable for efficacy, according to the abstract. Of those six patients, two attained a complete remission following Adcetris therapy. One of the responding patients was diagnosed with diffuse large B-cell lymphoma. Adcetris works by attaching itself to receptors on cancer cells that express a protein known as CD30. This protein is common in blood-related cancers but may also be found in solid tumors, which could open a larger commercial opportunity for Adcetris. Abstract No. 3069 reports on a study in which 875 patients -- 95% of whom were diagnosed with solid tumors -- were screened for CD30 expression. The screening found 22 patients (2.5%) who were CD30-positive, including patients with ovarian cancer, melanoma, mesothelioma and triple-negative breast cancer. Onyx Pharmaceuticals What we already know: An FDA advisory panel will review Onyx's multiple myeloma drug carfilzomib on June 20. Onyx is seeking approval based on a single-arm phase II study in 266 patients with relapsed or refractory multiple myeloma. The overall response rate to carfilzomib therapy was 22.9% with a median duration of response of 7.8 months. What's new in the ASCO abstracts: Abstract No. 8035 describes an analysis of carfilzomib response rates in the pivotal phase II based on prior treatment with Takeda's Velcade and Celgene's (CELG) Thalomid or Revlimid. This analysis is important because it addresses investor concerns that carfilzomib's response rate may not be potent enough in multiple myeloma patients who had depleted all other previous treatment options. In a subset of 228 patients refractory or intolerant to Velcade and at least one other immunomodulator like Thalomid or Revlimid, the carfilzomib response rate was 20.6% with a median duration of response of 7.4 months. In a smaller subset of 44 patients refractory all approved treatments, carfilzomib's response rate was 20.5% with a median duration of response of 7.8 months, according to the abstract.
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