- Adding Johnson & Johnson's Darzalex to a standard of care regimen consisting of dexamethasone and Celgene's Revlimid cut the risk of death or disease progression by 45% for newly diagnosed multiple myeloma patients ineligible for transplants, according to late-breaking data published Tuesday ahead of the upcoming American Society of Hematology's annual conference.
- An interim analysis of the Phase 3 MAIA study conducted in late September found median progression free survival hit 31.9 months for patients receiving Revlimid and dexamethasone. Meanwhile, median PFS hadn't yet been reached for patients receiving those two drugs plus Darzalex. The study arm that received Darzalex also saw a higher complete response rate than the arm that didn't, at 47.6% versus 24.7%, respectively.
- Though investigators noted no new safety signals when using the Darzalex combination for this patient population, there were still serious adverse events. Rates of Grade 3/4 pneumonia, neutropenia and leukopenia were all higher in the Darzalex arm versus the non-Darzalex arm.
Darzalex (daratumumab) has become a key growth driver for J&J in the roughly three years it's been on the market. The big pharma recorded $1.4 billion in worldwide sales of the CD38-targeting monoclonal antibody during the first nine months of 2018, a 65% increase from the same period a year prior.
Label expansions have proven integral to the growth. Darzalex first gained approval for multiple myeloma patients who received three prior therapies. In late 2016, the Food and Drug Administration cleared it in combination with either Revlimid (lenalidomide) and dexamethasone or Velcade (bortezomib) and dexamethasone for patients who received at least one prior therapy.
It would later lock down two more multiple myeloma indications in as many years, including one in May 2018 as a combo regimen with Velcade, melphalan and prednisone for newly diagnosed patients ineligible for autologous stem cell transplants (ASCT). Now, with the MAIA data in hand, it appears another valuable indication is within reach.
"We think the data including Revlimid is going to be really important going forward for the U.S. market," Jennifer Taubert, J&J's worldwide chairman for pharmaceuticals, said on the company's third quarter earnings call in mid-October.
About 60% of Darzalex sales come from the U.S. But, to Taubert's point, the market there for multiple myeloma treatments is crowded. If J&J can show its drug belongs as a standard option for more subsets of patients, it could go a long way to bolstering the brand.
J&J achieved such a feat once already with the ALYCONE study, which led to Darzalex's May 2018 approval. That investigation found adding Darzalex to the standard combo regimen for newly diagnosed patients who can't undergo ASCTs significantly improved overall response rates.
"These data together with the Phase 3 ALCYONE study ... support the addition of [Darzalex] to standard of care combinations in patients with [newly diagnosed multiple myeloma] ineligible for transplant," researchers concluded in the MAIA late-breaking abstract.