Janssen plans to share new data from Phase 3 trials of Darzalex (daratumumab) for multiple myeloma at the 59th American Society of Hematology (ASH) Annual Meeting, scheduled for Dec. 9-12 in Atlanta.
The presentations will include analyses of Darzalex’s ability to prolong overall and progression-free survival when used in combination with other drugs in the CASTOR and POLLUX trials.
“This year’s ASH meeting promises important updates for approved and investigational compounds across our hematology portfolio,” Dr. Peter Lebowitz, global therapeutic area head of oncology at Janssen Research & Development, said in a press release.
The ongoing Phase 3 CASTOR and POLLUX trials (NCT02136134 and NCT02076009) are examining Darzalex with dexamethasone and either Revlimid (lenalidomide) or Velcade (bortezomib) in earlier treated patients with myeloma.
Suzanne Lentzsch o Columbia University Medical Center will present data showing that patients with relapsed or treatment refractory myeloma, treated with Darzalex, Velcade and dexamethasone in the CASTOR study, appear to survive longer with Darzalex-based treatment than those given only Velcade and dexamethasone.
All patients has been treated earlier; 61 percent had gone through an autologous stem cell transplant and 66 percent had received Velcade before the study.
After a median follow-up of 19.4 months, more than half of the roughly 250 patients in each treatment group were still alive. An exploratory analysis suggested that more patients in the Darzalex group were alive at 24 months. At the meeting, Lentzsch will update survival figures.
Meanwhile, Meletios A. Dimopoulos of Greece’s National and Kapodistrian University of Athens will showcase data from the POLLUX study. The updated analysis from the trial showed that Darzalex with Revlimid and dexamethasone prolonged progression-free survival compared to Revlimid and dexamethasone alone.
After a median follow-up of 25.4 months, more than half of patients in the Darzalex-group were still alive without experiencing disease progression, while those who received treatement without Darzalex had a median progression-free survival of 17.5 months.
The study showed that more patients in the Dazalex group responded to treatment — 92 percent compared to 76 percent in the control group. Researchers also said that Darzalex’s safety profile was maintained during prolonged treatment.
In addition, the study showed that patients who did progress responded better to the next therapy if they had been treated with Darzalex.
CASTOR and POLLUX have already led to Darzalex’s approval in the United States, European Union and Japan, in combination with dexamethasone and Revlimid, or dexamethasone and Velcade for relapsed or refractory myeloma patients.