Amgen kicks off 2018 with double the good news for slow-growing Kyprolis

Could 2018 be the year Amgen’s Kyprolis finally starts living up to its sales potential? The big biotech hopes so—and it’s starting the year off with a pair of positive updates.

The California company said Wednesday the FDA had added more data to Kyprolis’ official label—specifically, data that showed Kyprolis, paired with dexamethasone, topped standard-bearer Velcade in multiple myeloma. In the Endeavor trial, Kyprolis showed it could cut the risk of death by 21% and increase overall survival by 7.6 months when compared with the Takeda blockbuster teamed with dexamethasone.

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The way Amgen sees it, the label update supports the Kyprolis-dexamethasone combo’s status as the only preferred two-drug regimen recommended by the National Comprehensive Cancer Network Clinical Practice Guidelines for relapsed multiple myeloma patients. 

"Blood cancer therapies approved by the FDA between 2003 and 2013 only improved overall survival by an average of 2.61 months,” David Reese, Amgen’s SVP of translational sciences and oncology, said in a statement, adding that Kyprolis’ 7.6 month advantage underscores “that this regimen is a significant advancement and should be considered a standard of care for patients with relapsed or refractory multiple myeloma."

Separately, the Journal of Clinical Oncology Wednesday published positive overall survival findings from an analysis of the phase 3 Aspire trial. That study showed that adding Kyprolis to Celgene’s Revlimid and dexamethasone could slash the risk of death by 21% and extend patients' lives by 7.9 months in relapsed or treatment-resistant patients. 

And now, Amgen working with regulators to get those results added to Kyprolis’ label, too, Reese said.

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As Barclays analyst Geoff Meacham wrote when the Endeavor overall survival results debuted last year, the data “could help to offset competitive pressure” in the second-line setting and beyond. And with a slew of new rivals hanging around—including Johnson & Johnson giant Darzalex—that’s exactly what Kyprolis needs. Through the first nine months of 2017, the therapy pulled in $412 million in U.S. sales—just $1 million more than it did in the same period the year before.

That’s not exactly the kind of growth Amgen envisioned when it shelled out $10 billion for Kyprolis’ maker, Onyx, back in 2013. But the company is hoping that displacing two separate standard-of-care regimens can help Kyprolis surge.

"As seen in two different phase 3 studies, Kyprolis-based regimens are the first and only therapy combinations to demonstrate a significant overall survival advantage for patients with relapsed or refractory multiple myeloma versus recent standards of care," Reese said.