Amgen’s Myeloma Drug Doesn’t Top Takeda’s in First-Line Use

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  • U.S. drugmaker seeking expanded label in myeloma treatment
  • Amgen’s Kyprolis doesn’t show superiority to Velcade

Amgen Inc.’s cancer drug Kyprolis didn’t show superiority over a rival drug when used as a first-line treatment for patients with multiple myeloma, potentially hindering the drugmaker’s efforts to expand the treatment’s label.

Patients taking Kyprolis with the chemotherapy drug melphalan and prednisone, a steroid, lived for a median of 22.3 months without their disease progressing, according to a company statement on Tuesday. That compared to 22.1 months for patients taking Takeda Pharmaceutical Co.’s Velcade along with melphalan and prednisone.

Amgen had high hopes for the trial after showing last year that Kyprolis doubled progression-free survival compared with Velcade for patients who had already failed on one prior treatment. Kyprolis, a type of treatment called a proteasome inhibitor that blocks protein breakdown in cells, was approved in July 2015 for use after another therapy has failed, and has not yet been approved for first-line use.

The result is “a setback for Amgen’s proteasome inhibitor program, and is consistent with our cautious view of the outlook for Kyprolis," Geoffrey Porges, an analyst with Leerink Partners who recommends holding Amgen, said Tuesday in a note to clients. “It seems likely that soon-to-be-generic Velcade will be the proteasome inhibitor of choice in front line patients.”

Disappointing Results

Velcade’s patent is set to expire next year.

The results “are disappointing, especially given the robust data we’ve seen in the second-line setting,” said Sean Harper, Amgen’s executive vice president of research and development, in the statement. “We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”

Amgen fell 2.4 percent to $171.01 at 11:10 a.m. in New York.

During a conference call Amgen held Tuesday, some oncologists said the combination of medicines used in the trial is not typically used by doctors treating myeloma patients in the U.S.

“Disappointing results but predictable to some extent,” Andrzej Jakubowiak, a professor of medicine at the University of Chicago who participated in the development of Amgen’s drug, said during the call. Jakubowiak said he still believes in the importance of Kyprolis “for future progress.”

Another Path

Kyprolis is expected to draw $732 million in sales this year, the average of analysts’ estimates compiled by Bloomberg. Velcade is Japanese drugmaker Takeda’s best-selling drug with sales of about $1.4 billion last fiscal year.

Amgen may have another path to earlier-stage treatment. The drugmaker is supporting a trial comparing Kyprolis and Velcade in newly diagnosed patients, according to the statement. That trial uses each of the drugs in combination with Celgene Corp.’s Revlimid and dexamethasone, a steroid.

"We were well along in the design of additional first-line studies, but we now need to re-evaluate the designs of these studies and the implications” of the study reported today, said Kristen Neese, an Amgen spokeswoman, in an e-mail.

(Updates with oncologist’s comment in sixth paragraph.)
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