Bad news for Amgen’s first-line Kyprolis ambitions: The med has flopped in its first Phase III study in newly diagnosed multiple myeloma patients.
Kyprolis, combined with melphalan and prednisone, failed to significantly top a cocktail of melphalan, prednisone and Johnson & Johnson and Takeda’s Velcade at improving progression-free survival or overall survival, a secondary endpoint, the Big Biotech said Tuesday.
Patients on the Kyprolis regimen went a median 22.3 months without their disease worsening, while patients in the Velcade arm went 22.1 months, Amgen said.
The results are a “setback” for Amgen, Leerink Partners analyst Geoffrey Porges wrote in a note to clients--especially considering that the first-line setting boasts the highest number of patients and the longest duration of therapy, which would mean a much bigger sales opportunity.
As Amgen R&D chief told investors on a Tuesday conference call, though, in the years since Kyprolis maker Onyx--which Amgen snapped up for $10 billion in 2013--designed the trial, “the treatment landscape has evolved rapidly." And these days, he stressed, “melphalan-based regimens are rarely used in the U.S.”
Amgen was quick to point out that there's another first-line Kyprolis trial underway at the ECOG-ACRIN Cancer Research Group, which pits the Amgen drug alongside Celgene’s Revlimid and dexamethasone, against Velcade, Revlimid and dexamethasone. The California drugmaker is already in talks with ECOG about potentially using that trial to file for a label expansion down the line, and “we certainly are going to redouble our discussions on that,” Harper assured investors.
The most recent miss, though, “does not inspire confidence in that trial,” Evercore ISI analyst John Scotti wrote in a research note--and it also “raises questions about the positive results from earlier head-to-head trials” in later lines of treatment, Porges wrote.
The outcome is “likely to undermine Amgen’s attempts to have the drug included in emerging front line treatment trials,” he said.
Meanwhile, the fact that Velcade generics are on the way--with the giant’s patent set to expire next year--isn’t helping Amgen’s cause. With knockoffs on the horizon, it’s “likely that cooling” of consensus peak sales “will continue after today’s result,” Scotti wrote.
Porges, for one, is already putting his own sales estimates below consensus marks, predicting worldwide sales of $715 million this year and $965 million in 2017.
But while near-term projections have taken a hit on recent quarterly misses, estimates for 2018 to 2020 “have remained largely intact,” Porges noted, which “suggests the street still believes the potential of durable growth in the relapsed/ refractory setting and incremental front-line use with Revlimid plus dexamethasone.”
Scotti agreed that Kyprolis would still probably “play a role” in the second-line setting, becoming a go-to for patients who fail a Velcade-Revlimid-dexamethasone cocktail.
- read Amgen's release
Amgen exec: Don't blame J&J rival Darzalex for Kyprolis' latest sales shortfall
Amgen's Kyprolis stands its ground against new J&J, BMS rivals
Amgen's Kyprolis wins 'backbone therapy' FDA nod after trumping Velcade in trial
Was Onyx worth it? Amgen's case is looking up as Kyprolis bests Velcade in head-to-head trial