- Two newer drugs for multiple myeloma failed to improve on a commonly used treatment regimen in separate late-stage studies of newly diagnosed patients, showcasing the difficulty in improving on Celgene's top-seller Revlimid in early disease settings.
- Adding Bristol Myers Squibb's Empliciti or Takeda's Ninlaro, both drugs approved for the blood cancer in late 2015, to a combination of Revlimid and dexamethasone proved no better than the Revlimid pairing alone, according to statements from their respective makers on Monday and Tuesday.
- Both Bristol Myers' and Takeda's trials were testing the drugs in patients who were ineligible for stem cell transplants and hadn't yet received drug therapy for their disease.
Empliciti and Ninlaro were the final two drugs cleared by the Food and Drug Administration in a three-year spate of approvals that brought to market six new treatment options for multiple myeloma.
Of those six, however, Johnson & Johnson's drug Darzalex has emerged as the top performer, winning multiple OKs from the FDA for use in five different combination regimens and as a monotherapy. Importantly, several of those approvals cleared the drug for use in newly diagnosed patients, allowing J&J to challenge Celgene — now Bristol Myers Squibb — in the broad first-line treatment setting.
Bristol Myers' Phase 3 study of Empliciti began in 2011, enrolling 750 newly diagnosed, transplant-ineligible patients to receive either a triple drug combination with Emplicit, Revlimid and the steroid dexamethasone, or Revlimid and dexamethasone alone.
A final study analysis showed adding Empliciti did not extend progression-free survival by a significant margin over Revlimid and dexamethasone. The safety profile of Empliciti was consistent with previous studies, Bristol Myers said.
Empliciti is approved to treat patients who have received at least two prior therapies, when combined with Pomalyst and dexamethasone.
Buying Celgene and its multiple myeloma drug business means Empliciti is less critical to Bristol Myers' future growth.
Ninlaro's failure in Takeda's Phase 3 study, by contrast, is a bit more of a blow for the Japanese drugmaker, which has a less extensive cancer drug portfolio.
Called TOURMALINE-MM2, the trial investigated Ninlaro in a similar way to Bristol Myers' test of Emplicti. Ninlaro was added to Revlimid and dexamethasone, then compared to the two drugs alone in newly diagnosed, transplant-ineligible patients.
Topline data shared by Takeda showed the Ninlaro-including regimen did appear to numerically improve median progression-free survival by about a year, but the margin was not significant over what was observed with Revlimid and dexamethasone.
Takeda started its trial in 2013 and enrolled just over 700 patients.
Recently, multiple myeloma drug development activity has picked up. The FDA approved Karyopharm's Xpovio for penta-refractory patients in July of 2019, and earlier this month cleared Sanofi's Sarclisa, which works in a similar way to J&J's Darzalex.
A range of drugmakers, including Bristol Myers, GlaxoSmithKline and J&J, are working on new types of treatments, including cell therapies and antibodies that bind to two targets rather than one.