Biotechnology Healthcare - June 2008 - (Page 7) DRUG TRACK Research, Conferences, and FDA Actions Bob Carlson, MHA, Senior Contributing Editor Oncology trials One of three international multicenter trials of ipilimumab did not meet its primary endpoint, but best objective response rates over all three trials were encouraging. The trials assessed the investigational immunotherapy as monotherapy in patients with stage 3 or 4 metastatic melanoma. Medarex and BMS are assessing ipilimumab, which has fast-track status, in other cancers and plan to file for FDA approval later this year. … Pfizer discontinued a phase 3 trial of tremelimumab in patients with advanced melanoma, after the trial failed to demonstrate superiority to chemotherapy. … As reported in the Journal of Clinical Oncology, patients with metastatic melanoma who received at least 10 injections of Antigenics’ patient-specific therapeutic cancer vaccine vitespen (Oncophage) experienced median survival of 16.5 months, compared to 12.8 months for those who received physician’s choice of treatment in a phase 3 study. Vitespen was approved in Russia on April 7 — the first therapeutic cancer vaccine to win regulatory approval anywhere in the world. In a phase 2 trial of 72 multiple myeloma patients, a combination regimen of clarithromycin (Biaxin), lenalidomide (Revlimid), and dexamethasone (BiRD) as first-line therapy resulted in overall and complete response rates of 90 and 39 percent, respectively. Mean time of treatment was 1 year. The authors of the study, published in Blood, say the high overall response rate may result from the use of low-dose dexamethasone and prolonged use of lenalidomide, rather than the addition of clarithromycin to the regimen. Several studies have reported lower toxicity in patients given lenalidomide in combination with low-dose dexamethasone compared with higher-dose regimens. In patients with advanced colorectal cancer that had not responded to other treatments, cetuximab (Erbitux) extended survival to 6.1 months compared to 4.6 months for supportive care. The study was published in the New England Journal of Medicine. When administered with docetaxel chemotherapy, bevacizumab (Avastin) prolonged progressionfree survival in chemo-naïve patients with locally recurrent or metastatic HER2-negative breast cancer, according to phase 3 data to be presented at the American Society of Clinical Oncology meeting in June. … Progression-free survival (PFS) in patients with renal cell carcinoma almost doubled when bevacizumab was added to a regimen of interferon alfa 2a (Roferon A), in a large phase 3 trial published in the Lancet. PFS was 10.2 months in patients who received the combination therapy, versus 5.4 months for those who were treated with interferon alone. An independent data monitoring committee ended a phase 3 trial of everolimus early after it met its endpoint of significantly better PFS in patients with advanced kidney cancer compared to placebo. Novartis plans regulatory filings later this year. … Another committee has approved the continuation of two phase 3 trials of Amgen’s panitu- Meeting highlights American Society of Hematology December 2007 In treatment-naïve multiple myeloma patients, 96 percent of those given lenalidomide (Revlimid) in combination with low-dose dexamethasone were alive after 1 year, compared with an 88 percent survival rate among those given lenalidomide and high-dose dexamethasone. More than 60 percent of 387 patients with chronic myelogenous leukemia who were resistant to or intolerant of therapy with imatinib (Gleevec) responded to dasatinib (Sprycel) in a multicenter study. In an analysis of patients with relapsed or refractory chronic lymphocytic leukemia who achieved complete remission in a phase 3 trial of oblimersen sodium (Genasense), median survival was 55 months in oblimersen-treated patients, versus 45 months in chemotherapy-only patients. Long-term treatment with eculizumab (Soliris) was associated with significant improvement and stabilization of kidney function in an openlabel study of patients with paroxysmal nocturnal hemoglobinuria. Azacitidine for injection (Vidaza) provided a significantly higher survival benefit (24 months) than conventional care (15 months) in patients with myelodysplastic syndromes who are at high risk for relapse. MAY/JUNE 2008 · BIOTECHNOLOGY HEALTHCARE 7
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