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【drug-news】试比格力卫，辉瑞bosutinib败落
试比格力卫，辉瑞bosutinib败落，不过还有机会，做重磅药已难
With investors still digesting the news of Jeff Kindler's quick exit, Pfizer ($PFE) had yet another pivotal trial failure on its hands. This time around the bad news was about bosutinib, a cancer drug being studied in a head-to-head study with Gleevec as a treatment for chronic myeloid leukemia. Bosutinib failed to demonstrate a superior complete cytogenetic response when compared with Gleevec after a year of treatment. But researchers were happy to tout a better major molecular response profile, a secondary endpoint. And Pfizer says that despite the Phase III primary endpoint setback, it still has enough data in hand to head to regulators to seek an approval.
"We are encouraged by these data, as they demonstrate early and meaningful response to bosutinib in patients with newly diagnosed CML. Given the length of time these patients are treated for CML, we need more therapeutic options to choose from since each patient is different and has different needs," said Dr. Carlo Gambacorti-Passerini, a lead investigator of the BELA study. "Based on my experience with bosutinib, I feel it would be an important option for patients with CML."
Pfizer singled out bosutinib at the beginning of this year as one of its most promising late-stage oncology programs following the big merger with Wyeth. And it's determined to capitalize on the work.
"Based on the totality of evidence from the bosutinib clinical development program, we are actively engaged in discussions with regulatory authorities which we hope will enable Pfizer to offer a new treatment option for patients with CML," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit.
辉瑞对外公告
Pfizer Announces Phase 3 Results of Investigational Compound Bosutinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia
Posted December 6, 2010
Bosutinib Demonstrates Improvement Over Imatinib in Major Molecular Response Rate at One Year Despite Missing Primary Endpoint of Complete Cytogenetic Response Rate at One Year
Download image NEW YORK, Dec. 6, 2010 /PRNewswire/ -- Pfizer Inc. (NYSE: PFE) announced today that a significantly higher proportion of patients with newly diagnosed chronic myeloid leukemia who were treated with bosutinib (39 percent) experienced a major molecular response (MMR), a secondary endpoint, compared with patients treated with imatinib (26 percent) in the intent-to-treat (ITT) population (p=0.002). However, the study did not meet its primary endpoint of superior complete cytogenetic response (CCyR) rate at one year versus imatinib (70 percent vs. 68 percent, respectively, [p=0.601]), in the ITT population. These results are from a Phase 3 study of the investigational compound bosutinib as a first-line treatment in patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), called the Bosutinib Efficacy and safety in chronic myeloid LeukemiA [BELA] study. These data were presented at an oral presentation at the 52nd Annual Meeting of the American Society of Hematology (ASH)
Preliminary data show that fewer patients who took bosutinib progressed to an advanced phase of the disease (n=4, 1.6 percent) compared to patients treated with imatinib (n= 10, 4.0 percent), and there were fewer deaths in the bosutinib arm (n=4, 1.2 percent) than in the imatinib arm (n= 10, 3.2 percent). Patients responding to bosutinib achieved CCyR faster than those responding to imatinib (13 weeks vs. 25 weeks, p<0.001).(1)
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A pre-specified exploratory analysis also showed that bosutinib produced a higher rate of CCyR at one year compared to imatinib when CCyR was assessed only in the evaluable patient population, 78 percent with bosutinib (n=219) compared to 69 percent with imatinib (n=241). The evaluable population was different from the ITT population in that it included only those patients who received follow-up assessments for efficacy.(1)
The most frequently reported all-grade drug-related adverse events with bosutinib were diarrhea (66 percent), nausea (27 percent), vomiting (25 percent), and rash (18 percent). The most frequent grade 3/4 adverse events with bosutinib included diarrhea (8 percent) and rash (2 percent), although no patients on the bosutinib arm discontinued therapy due to diarrhea. Gastrointestinal events associated with bosutinib had an early onset and usually subsided within the first four weeks of treatment. Most frequent grade 3/4 laboratory abnormalities with bosutinib included elevated ALT (21 percent), elevated AST (10 percent), and thrombocytopenia (7 percent).(1)
More patients on bosutinib experienced serious adverse events (25.4 percent vs. 13.5 percent) and adverse events leading to discontinuation (19.4 percent vs. 5.6 percent) than on imatinib. Adverse events leading to discontinuation were most frequently due to liver enzyme elevations in the bosutinib arm and neutropenia in the imatinib arm. There were no deaths in the study due to treatment-related adverse events. The majority of patients on both treatment arms continued on study treatment after a median follow-up of 14 months.(1)
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作者:admin@医学,生命科学 2011-01-26 11:42
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