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.
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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.”