Amgen says ovarian cancer drug meets goal of late-stage study

AMGEN INC.'s experimental drug for ovarian cancer, trebnanib, has met a late-stage study goal, the biotechnology company said Wednesday.
Posted 6/12/13

NEW YORK - Amgen Inc., the world’s largest biotechnology company by sales, said its experimental drug for recurrent ovarian cancer met a late-stage study goal, helping patients live 1.8 months longer without the disease progressing.

Patients taking trebananib plus the chemotherapy paclitaxel lived a median 7.2 months without their cancer advancing, compared with 5.4 months in the group on paclitaxel alone, Thousand Oaks, California-based Amgen said today in a statement. The company said it expects data on overall survival, an important measure of a drug’s effectiveness, in 2014.

There will be about 22,240 new cases of ovarian cancer in the U.S. this year, with about 14,230 deaths from the disease, according to estimates from the American Cancer Society. More than 70 percent of women with ovarian cancer have an advanced form of the disease when they are diagnosed, and as many as 80 percent will have their disease recur, Amgen said.

“These results suggest that the novel biology of trebananib may offer a promising approach for patients with ovarian cancer,” Sean E. Harper, Amgen’s executive vice president of research and development, said in the statement.

Trebananib is being tested in three studies in the final phase generally required by regulators for approval. The study reported today, called Trinova-1, included more than 900 women. The most common side effects of the drug were swelling, nausea and alopecia, or hair loss. The rate of discontinuation because of adverse events was 20 percent on trebananib plus paclitaxel compared with 7 percent for those on paclitaxel alone.

Amgen rose less than 1 percent to $98.30 at 9:31 a.m. New York time. The shares gained 14 percent this year through yesterday.

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