J&J Published Data from Phase 3 DARZALEX® Study

| By | Cancer Drugs, Janssen, Johnson & Johnson

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the publication of data from the randomized, open-label Phase 3 MAIA (MMY3008) study that showed DARZALEX® (daratumumab) plus lenalidomide and dexamethasone (Rd) resulted in a significant increase in progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). These data were published in The New England Journal of Medicine.

“We continue to see scientific evidence through Phase 3 studies that support the use of daratumumab in combination with standard of care regimens,”

said Thierry Facon, M.D., Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, MAIA investigator and author of the study.

“As multiple myeloma can become more complex at each relapse, it is important to select an optimal upfront therapy. Results from the MAIA study suggest that this daratumumab combination therapy should be considered for patients with multiple myeloma who are transplant ineligible upon diagnosis.”

Results from the MAIA study demonstrated that at a median follow-up of 28 months, DARZALEX, in combination with Rd, reduced the risk of disease progression or death by 44 percent in patients with newly diagnosed multiple myeloma who are ineligible for ASCT, compared to treatment with Rd alone (Hazard Ratio [HR] = 0.56; 95 percent confidence interval [CI]: 0.43-0.73; p<0.001). The median PFS for DARZALEX-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone. The overall response rate (ORR) was 92.9 percent in the DARZALEX-Rd arm versus 81.3 percent in the Rd arm (p<0.001). The addition of DARZALEX resulted in near-doubling of complete response (CR) or better (47.6 percent vs. 24.9 percent). In the MAIA study, treatment with DARZALEX-Rd resulted in a greater than threefold rate of minimal residual disease (MRD) negativity compared to Rd alone (24.2 percent vs. 7.3 percent). All patients with MRD-negative status also had a response of CR or better. Patients who achieved MRD negativity demonstrated longer PFS than patients who remained MRD-positive, regardless of study treatment.

The safety of DARZALEX in combination with Rd in this patient population was consistent with previously reported studies. The most common Grade 3 or 4 adverse events (AEs) (>10 percent) in the DARZALEX-Rd arm compared to Rd alone were neutropenia (50.0 percent vs. 35.3 percent), lymphopenia (15.1 percent vs. 10.7 percent), pneumonia (13.7 percent vs. 7.9 percent), anemia (11.8 vs. 19.7 percent), and leukopenia (11.0 percent vs. 4.9 percent), respectively. AEs leading to treatment discontinuation were less frequent in the DARZALEX-Rd group than with Rd alone (7.1 percent vs. 15.9 percent, respectively), despite the higher rate of neutropenia and pneumonia in the DARZALEX-Rd arm. There were fewer patients who discontinued the study treatment due to infections in DARZALEX-Rd versus Rd alone (0.5 percent vs. 1.4 percent, respectively). DARZALEX-associated infusion-related reactions (IRR) were reported in 40.9 percent of patients (2.7 percent were Grade 3 or 4); there were no Grade 5 events. One patient discontinued treatment with DARZALEX after an IRR.

“The MAIA study findings demonstrate a consistent and clinically meaningful treatment effect when DARZALEX is incorporated into standard backbone regimens, such as lenalidomide and dexamethasone, for the initial treatment of patients with multiple myeloma who are transplant ineligible,”

said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC.

We have submitted applications to global health authorities in support of the MAIA dataand look forward to working with regulators in the hope of bringing a new combination regimen to patients diagnosed with multiple myeloma.”

SOURCE: jnj.com
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