Amgen has more good news out of the study that pitted its Kyprolis against Takeda multiple myeloma rival Velcade—and it’s news that could help it fend off a group of rivals in the second-line setting.
On Tuesday, the Big Biotech announced that in a phase 3 head-to-head trial, relapsed or refractory patients taking a Kyprolis-dexamethasone combo lived 7.6 months longer than those taking dexamethasone with Takeda’s blockbuster. Kyprolis had already posted a significant progression-free survival (PFS) benefit over its nemesis.
It’s a big win for Kyprolis in what company R&D chief Sean Harper, M.D., called “the only study to demonstrate a survival benefit in a head-to-head” matchup with a standard-of-care regimen. "A survival benefit has rarely been demonstrated in relapsed or refractory multiple myeloma,” he said in a statement.
And moreover, the way Barclays analyst Geoff Meacham sees it, the data “could help to offset competitive pressure” in the second-line setting and beyond.
There’s certainly plenty of that around, thanks to a slew of next-gen treatments that nabbed approvals in late 2015. That November, U.S. regulators cleared Takeda’s Ninlaro and AbbVie and Bristol-Myers Squibb’s Empliciti for use in second-line cocktails, and Johnson & Johnson’s Darzalex—initially green-lighted only for patients who had failed on three or more previous lines of therapy—won a bump-up to second line last November.
The increased competition only heightened worries over Kyprolis, which has gotten off to a slow start since Amgen shelled out $10 billion for maker Onyx in 2013. But “we think that the positive interim results … should help to alleviate concerns about intermediate term Kyprolis growth slowing due to competitive pressure” from the newcomers, Meacham wrote.
And an overall survival (OS) victory may do even more than that, he figures. Kyprolis failed to put up a PFS benefit last year in newly diagnosed patients, putting a hurdle between Amgen and a larger population of patients who tend to stay on therapy for longer. But the new results “now potentially provide an OS rational for utilization,” he said.
With that in mind, “we continue to see strength in the asset,” he wrote. He predicts the med—which brought in $692 million last year—will increase that haul to $930 million in 2017 and swell to $1.6 billion in 2021.