- New data released Tuesday showed adding Johnson & Johnson's blood cancer drug Darzalex to standard treatment dramatically extended progression-free survival in certain patients with newly diagnosed multiple myeloma.
- Among patients who were ineligible for transplant, pairing Darzalex with a cocktail of other drugs cut the risk of disease progression or death in half when compared to patients treated with that standard regimen alone.
- The results could broaden the market for Darzalex, one of J&J’s important new medicines. Already, the pharma has applied for an expanded approval of the drug in the U.S. and Europe based on the study results, which will be presented at a medical conference next month.
Darzalex (daratumumab) is currently approved to treat multiple myeloma only in patients who have previously received treatment. The data unveiled Tuesday should support a regulatory OK to move Darzalex into the frontline setting for those patients who aren't good candidates for stem cell transplants.
Securing a first-line indication will be important to further boost sales growth of the drug, which J&J licenses from the Danish drugmaker Genmab A/S.
In a 706-patient study called ALCYONE, J&J added Darzalex to a combination of Takeda Pharmaceutical Co. Ltd.'s Velcade (bortzeomib), melphalan and prednisone — commonly abbreviated as VMP.
Treatment with Darzalex plus VMP effectively doubled progression-free survival versus VMP by itself, and notched higher objective response and complete response rates than the combo alone.
At a median follow-up of 16.5 months, median progression-free survival in the treatment arm had not been reached — meaning more than 50% of participants had yet to experience disease progression — compared to a median of 18.1 months for those treated with VMP.
Adding Darzalex to VMP was associated with a higher rate of serious infections, however.
Hoping to speed a regulatory decision, J&J's Janssen unit has requested priority review from the Food and Drug Administration for its supplemental Biologics License Application. The FDA typically notifies companies within 60 days of whether it will grant an accelerated review.
Commercially, sales of Darzalex have grown strongly since its first approval in November 2015. Last year — the drug's first full year on the market — worldwide sales reached $572 million. 2017 revenues have already topped that figure, with sales in the third quarter alone totaling $317 million.
J&J's top oncology product is the prostate cancer drug Zytiga (abiraterone). But with Darzalex and a partnership on AbbVie Inc.'s fast-growing Imbruvica (ibrutinib), the pharma giant can now boast a strong franchise in blood cancers too.