Treatment with the combination of the bispecific antibodies teclistamab-cqyv (Tecvayli) and talquetamab-tgvs (Talvey) significantly improved progression-free survival (PFS) and overall survival (OS) vs investigator’s choice of standard-of-care (SOC) therapy in patients with relapsed/refractory multiple myeloma who had received 1 to 4 prior lines of therapy, according to topline results from the phase 3 MonumenTAL-6 trial (NCT06208150).1
Data announced in a news release from Johnson & Johnson showed that teclistamab plus talquetamab reduced the risk of disease progression or death by 89% (HR, 0.11; 95% CI, 0.08-0.16; P < .0001) and reduced the risk of death by 62% (HR, 0.38) compared with SOC, which comprised investigator’s choice of elotuzumab (Empliciti), pomalidomide (Pomalyst), and dexamethasone (EPd), or pomalidomide, bortezomib (Velcade), and dexamethasone (PVd).
In the study’s second investigational arm, talquetamab plus pomalidomide also met the primary end point, reducing the risk of disease progression or death by 73% vs SOC (HR, 0.27; 95% CI, 0.2-0.35).
Johnson & Johnson reported that the overall safety profiles for both investigational arms were consistent with the known safety profiles of each agent as monotherapy. Full results from MonumenTAL-6 will be presented at a future medical meeting and shared with global health authorities.
“These findings add to a growing body of phase 3 evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey,” Ajay K. Nooka, MD, MPH, FACP, director of the Myeloma Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta, Georgia, stated in a news release. “[Teclistamab] and [talquetamab] together generated deep and durable responses, demonstrating what’s possible by targeting BCMA and GPRC5D at the same time, and further reinforcing the potential of this off-the-shelf regimen to improve outcomes for patients across practice settings.
MonumenTAL-6 is a global, randomized, open-label, three-arm, phase 3 study evaluating teclistamab plus talquetamab and talquetamab plus pomalidomide vs investigator’s choice of EPd or PVd in patients at least 18 years of age with relpased/refractory multiple myeloma who experienced disease progression or did not achieve a minimal response to their last line of therapy.5
To be eligible, patients were required to have documented multiple myeloma with measurable disease per International Myeloma Working Group criteria, relapsed or refractory disease, and an ECOG performance status of 0 to 2. Enrolled patients had received 1 to 4 prior lines of therapy that included an anti-CD38 monoclonal antibody and lenalidomide (Revlimid).
In the experimental arms, patients received subcutaneous teclistamab plus subcutaneous talquetamab, or subcutaneous talquetamab plus oral pomalidomide, with dexamethasone administered as a pretreatment medication.1,5
The primary end point was PFS as assessed by an independent review committee. Key secondary end points included overall response rate, complete response (CR) or better, minimal residual disease–negative CR, and OS.
“At Johnson & Johnson, we have intentionally built a multiple myeloma portfolio that spans biological targets, mechanisms, modalities and lines of therapy, giving physicians the flexibility to use our therapies across a diverse patient population and throughout the patient journey,” Yusri Elsayed, MD, MHSc, PhD, Global Therapeutic Area head, Oncology, at Johnson & Johnson, added in a news release.1 “These findings further reinforce immunotherapy as a cornerstone of multiple myeloma care and strengthen the growing body of evidence supporting our leadership in this space. By continuing to expand treatment options across the disease continuum, we are moving closer to our ambition of one day curing this disease.”
