Policy & Regulation
DarzalexRegimen Shows Significant Increase in Progression-Free Survival in Treatment of Patients with Relapsed/Refractory Multiple Myeloma
12 December 2019 - - US-based healthcare company Johnson and Johnson's (NYSE: JNJ) The Janssen Pharmaceutical Companies business has received results from the Phase 3 CANDOR study showing that the addition of Darzalex (daratumumab) to carfilzomib (Kyprolis) and dexamethasone, compared to carfilzomib and dexamethasone alone, significantly improved progression-free survival in patients with relapsed/refractory multiple myeloma, resulting in a 37% reduction in the risk of disease progression or death (Hazard Ratio [HR]=0.63; 95 % confidence interval [CI], 0.46-0.85; p=0.0014), the company said.

The study results were reported for the first time and presented as a Late-Breaking Abstract (#LBA-6) at the 2019 American Society of Hematology (ASH) annual meeting.

Results from the CANDOR study showed that, compared to Kd alone, DKd resulted in significantly longer PFS and response rates.

The primary endpoint of PFS was met after a median follow-up of 16.9 months and 16.3 months for the DKd and Kd arms, respectively.

Median PFS was not reached in the DKd arm versus 15.8 months in the Kd arm.

At 12 months, patients in the DKd arm had a 10 times higher rate of minimal residual disease -negativity compared to patients treated with Kd alone (12.5% vs. 1.3%; p