The drug-maker Amgen Inc. has reported that the late-stage trial of an ovarian cancer drug called trebananib has failed to generate any significant results when it comes to improvement in patient's survival.
Located in the Conejo Valley, Amgen is the world's largest independent biotechnology firm. The company explained that the anti-tumor treatment drug was intended to be used alongside the chemotherapy drug paclitaxel so as to evaluate its efficacy and safety in a Phase 3 study.
Phase 3 of the study is the late stage trial of the study and was done to evaluate the safety and efficacy of the treatment in treating patients with ovarian cancer. During this trial, all the patients were administered the drug along with chemotherapy. The result of the trial shows that patients who took trebananib had a median overall survival of 19.3 months while those in the control group had 18.3 months.
Amgen admitted that the results proved to be disappointment as the phase three shows that taking trebananib did not meet secondary endpoint goals for overall survival. All the participants of the trial reported several adverse side effects which included edema, alopecia (hair loss) and nausea. The trial's dropout rate was around 20%.
Sean E. Harper, M.D., executive vice-president of Research and Development at Amgen, said, "While the overall survival results of the TRINOVA-1 study are disappointing, this study is the first of three Phase 3 trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer We continue to explore the potential of trebananib's novel anti-tumor mechanism of action in other cancer settings".
Experts say that about 14,000 women in the United States die each year from ovarian cancer and more than 21,000 new cases are diagnosed each year. This drug is also under study as a possible treatment for other cancers like breast, kidney, lung and liver.
Located in the Conejo Valley, Amgen is the world's largest independent biotechnology firm. The company explained that the anti-tumor treatment drug was intended to be used alongside the chemotherapy drug paclitaxel so as to evaluate its efficacy and safety in a Phase 3 study.
Phase 3 of the study is the late stage trial of the study and was done to evaluate the safety and efficacy of the treatment in treating patients with ovarian cancer. During this trial, all the patients were administered the drug along with chemotherapy. The result of the trial shows that patients who took trebananib had a median overall survival of 19.3 months while those in the control group had 18.3 months.
Amgen admitted that the results proved to be disappointment as the phase three shows that taking trebananib did not meet secondary endpoint goals for overall survival. All the participants of the trial reported several adverse side effects which included edema, alopecia (hair loss) and nausea. The trial's dropout rate was around 20%.
Sean E. Harper, M.D., executive vice-president of Research and Development at Amgen, said, "While the overall survival results of the TRINOVA-1 study are disappointing, this study is the first of three Phase 3 trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer We continue to explore the potential of trebananib's novel anti-tumor mechanism of action in other cancer settings".
Experts say that about 14,000 women in the United States die each year from ovarian cancer and more than 21,000 new cases are diagnosed each year. This drug is also under study as a possible treatment for other cancers like breast, kidney, lung and liver.
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