Adding Darzalex (daratumumab) to a treatment combination of Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone increased the proportion of newly diagnosed patients with multiple myeloma showing complete cancer disappearance, according to top-line results of a Phase 2 clinical trial.
The open-label GRIFFIN study (NCT02874742) includes 223 patients eligible for high-dose chemotherapy and autologous stem cell transplant (ASCT). They were chosen randomly to be treated with either a combination of Janssen’s Darzalex plus Velcade, Revlimid, and dexamethasone (VRd), or VRd alone.
The results showed that 42.4% of the patients on Darzalex and VRd had no cancer signs after treatment, compared to 32% of those who received VRd alone. This result means that adding Darzalex to the treatment regimen leads to a 57% higher likelihood of achieving complete response.
Secondary goals, including an analysis of minimal residual disease (attainment of very low numbers of cancer cells in circulation after treatment), supported the benefits of using Darzalex with VRd. Safety results were consistent to using each therapy separately.
The team is still analyzing safety and efficacy results. Janssen, which licensed Darzalex from Genmab in 2012, plans to present updated findings at an upcoming medical conference.
Darzalex is an intravenous antibody therapy, which binds with high affinity to CD38, a molecule highly expressed on the surface of multiple myeloma cells. The medication boosts the anti-cancer immune response, leading to rapid tumor cell death through immune processes, immunomodulatory effects, and apoptosis, which refers to “programmed” cell death, as opposed to death caused by injury.
Both trials are still enrolling – (click on the links above for more information) and include previously untreated patients with multiple myeloma. Participants in CEPHEUS do not have hematopoietic stem cell transplant planned as initial therapy.
“The data … underlines the potential of daratumumab [Darzalex] when used in combination with VRd and supports Janssen’s decision to start the PERSEUS and CEPHEUS Phase III studies,” Jan van de Winkel, PhD, Genmab’s CEO, said in a press release.
Van de Winkel added that the results of GRIFFIN add to those of the CASSIOPEIA Phase 3 trial (NCT02541383), which tested Darzalex in combination with Velcade, thalidomide and dexamethasone, also in newly diagnosed multiple myeloma patients eligible for ASCT.
The U.S. Food and Drug Administration recently granted priority review to a supplemental biologics license application requesting approval of the combination approach in the same patient population as that included in CASSIOPEIA.
Janssen also has asked the FDA to approve a new under-the-skin formulation of daratumumab as a faster and easier treatment for multiple myeloma patients, after it showed similar safety and efficacy as intravenous Darzalex in two clinical trials.