View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
August 29, 2022

Janssen reports Phase II data for Darzalex-RVd to treat multiple myeloma

According to final trial data, Darzalex-RVd offered an MRD negativity rate of 64% compared to 30% in the RVd arm.

The Janssen Pharmaceutical Companies of Johnson & Johnson has reported final data from the Phase II GRIFFIN clinical trial of Darzalex (daratumumab) plus lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone (Darzalex-RVd) in recently diagnosed patients with multiple myeloma.

The randomised trial analysed the investigational usage of the Darzalex-RVd regimen in over 200 adult subjects aged 18 to 70 years with multiple myeloma, who are eligible for post-autologous stem cell transplant (ASCT).

It evaluated the Darzalex-RVd regimen which was followed by maintenance therapy comprising Darzalex-lenalidomide (R) versus RVd followed by maintenance therapy with R alone.

According to the final assessment data, Darzalex-RVd offered a minimal residual disease (MRD) negativity rate of 64% compared to 30% in the RVd arm following two years of maintenance therapy.

In the trial, 44% of the subjects in the Darzalex-RVd arm attained sustained MRD negativity that lasted 12 months or more versus 14% in the RVd arm.

Additionally, Darzalex-RVd treatment offered greater stringent complete response (sCR) rates at all time points in the trial, with top rates seen after two years of maintenance therapy.

In the Darzalex-RVd arm, CR or better rate was found to be 83% compared to 60% in the RVd arm.

A 55% decline in the disease progression or mortality risk was seen in subjects in the Darzalex-RVd arm following 49.6 months of median follow-up.

No new safety concerns were reported following extended follow-up in the trial.

Darzalex is a CD38-directed antibody.

Janssen Scientific Affairs Hematology Medical Affairs US vice-president Imran Khan said: “The Phase II GRIFFIN study showed important results with the investigational Darzalex quadruplet regimen in the treatment of newly diagnosed, transplant-eligible multiple myeloma.

“The evaluation of this treatment regimen will continue as part of the registrational, Phase III PERSEUS study.”

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Clinical Trials Arena