Janssen Announces Five-Year Follow-Up Data from Phase 3 MAIA Study Demonstrating Significant Survival Benefit of Darzalex (daratumumab) Plus Rd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma
Jun 17, 2021 02:02
CST Updated
02:02
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
Multiple Myeloma (Image from: cancer.gov)
June 16, 2021 News /BioonBIOON/ -- Johnson & Johnson (JNJ) recently announced the overall survival (OS) results from the Phase 3 MAIA study (NCT02252172). The study in patients not eligible for autologousStem Cellconducted in newly diagnosed multiple myeloma (NDMM) patients eligible for autologous stem cell transplantation (ASCT), evaluated the efficacy and safety of the Darzalex (daratumumab) plus lenalidomide and dexamethasone triple regimen (D-Rd), and compared it with the lenalidomide and dexamethasone doublet regimen (Rd). The results showed that,After nearly 5 years of follow-up, the D-Rd treatment group demonstrated a statistically significant survival benefit compared with the Rd treatment group.
The pre-specified OS interim analysis showed that,After a median follow-up of nearly 5 years (56.2 months), the risk of death was reduced by 32% in the D-Rd treatment group compared with the Rd treatment group, and median OS was not reached in either group.(HR=0.68, 95% CI: 0.53–0.86; p=0.0013). Additionally, the median progression-free survival (PFS) for the Rd treatment group was 34.4 months, whereas the median PFS for the D-Rd treatment group had not yet been reached after nearly 5 years of follow-up.The PFS benefit observed in the D-Rd treatment group continued to be maintained, with a 47% reduction in the risk of disease progression or death compared with the Rd treatment group.（HR=0.53；95%CI:0.43-0.66；p<0.0001）。
Additional new findings from the long-term follow-up analysis of the MAIA study also include: the estimated 5-year OS rate was 66% in the D-Rd treatment group versus 53% in the Rd group (HR=0.68; 95% CI: 0.53–0.86; p=0.0013); the estimated 5-year PFS rate was 53% in the D-Rd group versus 29% in the Rd group (HR=0.53; 95% CI: 0.43–0.66; p<0.0001). The median time to next treatment was not reached in the D-Rd group, compared with 42.4 months in the Rd group (HR=0.47; 95% CI: 0.37–0.59; p<0.0001). The updated overall response rate (ORR) was 93% in the D-Rd group and 82% in the Rd group. No new safety concerns were identified in the D-Rd group. The most common grade 3 or 4 treatment-emergentAdverse Reactions(TEAEs) were neutropenia (D-Rd: 54%; Rd: 37%), pneumonia (D-Rd: 19%; Rd: 11%),Anemia(D-Rd: 17%; Rd: 22%), lymphopenia (D-Rd: 16%; Rd: 11%).
Dr. Thierry Facon, MAIA trial investigator and Professor of Hematology at University Hospital of Lille, France, stated: “With each relapse, the treatment of multiple myeloma (MM) becomes increasingly complex. Therefore, utilizing frontline therapy to achieve deep treatment responses and improved survival is critical. These results strongly support the use of the Darzalex, lenalidomide, and dexamethasone triplet regimen as the new standard of care to prolong survival and improve clinical outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma.”
Darzalex is the first approved fully human monoclonal antibody targeting CD38. Featuring a unique and innovative mechanism of action, it directly and specifically binds to CD38, a key immunotherapeutic target on the surface of myeloma cells, and induces myeloma cell death through multiple mechanisms, achieving rapid remission.
Darzalex was launched in 2015 and has since become a backbone therapy for the clinical treatment of multiple myeloma (MM), widely used in first-line, second-line, and multiple lines of therapy.
In China, Darzalex (ZHAOKE®, daratumumab injection) was approved in July 2019.，To become the first fully human monoclonal antibody targeting CD38 approved in China, this drug is approved as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, specifically: patients who have previously received treatment including proteasome inhibitors and immunomodulatory agents and whose disease progressed on or after their last therapy.
In April 2021, Darzalex received additional approval in China for use in combination with lenalidomide and dexamethasone or with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy. The approval of this indication will further bridge the treatment gap in China for relapsed or refractory multiple myeloma, providing more innovative options for patients at earlier stages of treatment. (Bioon.com)