Results, Setbacks

Amgen hit with a setback as Kyprolis fails a key frontline trial for multiple myeloma

Sean Harper - Amgen EVP, Research and Development

Sean Harper, Executive Vice President, Research and Development

Amgen reported early Tuesday that Kyprolis has failed a Phase III trial for frontline use against multiple myeloma, a setback that can only further sharpen the disappointment analysts have felt for this therapy in light of weak sales.

Investigators say that Kyprolis combined with melphalan and prednisone essentially matched a triple combo using Takeda’s Velcade. The PFS for Kyprolis was 22.3 months compared to 22.1 months for the Velcade arm.

Amgen’s shares slid 2.3% in pre-market trading Tuesday.

The overall survival data have yet to mature for a read out, according to Amgen. But the big biotech didn’t have anything positive to report this morning.

Amgen had been hoping to use this study to help justify the $10.4 billion acquisition of Onyx Pharmaceuticals back in 2013, after Onyx had pushed the treatment through to an approval. Last year, Amgen had been bullish about its prospects in the blood cancer field after Kyprolis proved more effective in helping multiple myeloma patients who had failed at least one prior treatment compared to Velcade. And it followed up with a new approval for use against relapsed multiple myeloma in combination with Velcade.

Frontline use, though, would have opened up a major market opportunity to Amgen that the company badly needed. Kyprolis earned $512 million last year, up 55% from the year before. But you’ll find it at the tail end of the drugs Amgen reports on, leaving the big biotech looking for new ways to add revenue. Velcade, meanwhile, brings in blockbuster cash for Takeda, earning more than $2.5 billion a year.

Celgene is the leader in multiple myeloma, though, dominating the field with Revlimid and Pomalyst while J&J and Bristol-Myers Squibb have jumped in with Darzalex and Empliciti.

Looking over the field and weighing the setback at Amgen, Leerink’s Geoffrey Porges concluded that generic Velcade will be the dominant drug in use. He concluded:

“With the multiple myeloma field searching for the optimum combination treatment combination it seems likely that soon-to-be-generic Velcade will be the proteasome inhibitor of choice in front line patients with the backbone of J&J’s (JNJ, [OP]) Darzalex (daratumumab)‎, Celgene’s (CELG, [MP]) Revlimid (lenalidomide), and dexamethasone (aka Darzalex/ Rev/ Dex). Velcade’s patent is set to expire in 2017. A number of Kyprolis studies are still ongoing – and we are cautious about the outcomes. These trials include ARROW, a phase 3 trial of Kyprolis (with dex) relapsed and refractory MM, set to read-out mid- 2017; a phase 3 comparing Kyprolis vs. Velcade (both with rev/ dex) in newly diagnosed MM, set to read-out 2H 2017; and the overall survival data of phase 3 ENDEAVOR study of Kyprolis vs. Velcade (both with dex) in relapsed MM expected 2018.”

Said R&D chief Sean Harper:

“The CLARION results, generated in the context of a melphalan-containing regimen, are disappointing, especially given the robust data we’ve seen in the second-line setting. However, the myeloma landscape has changed dramatically since the design of the CLARION study with very few newly diagnosed patients treated with melphalan-based regimens, particularly in the U.S.  We remain committed to exploring Kyprolis in combination with other agents to advance the treatment of multiple myeloma.”


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