Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, has recently announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to TALVEY™ (talquetamab-tgvs), an innovative bispecific antibody developed for treating adult patients who are facing relapsed or refractory multiple myeloma. These patients should have undergone at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The approval decision is based on the assessment of response rate and response durability, with continued approval hinging on the confirmation of clinical benefits in subsequent trials.
TALVEY™ functions as a bispecific T-cell engaging antibody, simultaneously targeting the CD3 receptor on T cells and the G protein-coupled receptor class C group 5 member D (GPRC5D) found on multiple myeloma cells, as well as non-malignant plasma cells and normal tissue like epithelial cells in keratinized skin and tongue areas. The treatment protocol for TALVEY™ involves an initial step-up phase followed by subcutaneous injections on a weekly or biweekly basis, offering flexibility in treatment scheduling.
Clinical trials have demonstrated the promising therapeutic efficacy and safety of talquetamab, particularly in heavily treated patients, some of whom had previously undergone BCMA-targeted bispecific or CAR-T cell therapy. This is a significant development as patients at this advanced stage of the disease often face a challenging prognosis. TALVEY™ represents a new avenue of hope for those contending with this complex blood cancer.
The safety profile of TALVEY™ includes a Boxed Warning regarding cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Other warnings and precautions address issues such as oral toxicity, weight loss, infections, cytopenias, skin toxicity, hepatoxicity, and embryo-fetal toxicity. Common adverse reactions observed encompass pyrexia, CRS, dysgeusia, nail disorders, musculoskeletal pain, skin disorders, rash, fatigue, weight loss, dry mouth, xerosis, dysphagia, upper respiratory tract infections, diarrhea, hypotension, and headache. The most frequent Grade 3 or 4 laboratory abnormalities include decreased lymphocyte count, neutrophil count, white blood cell count, and hemoglobin levels.
Despite the significant expansion of treatment options for multiple myeloma, the disease remains incurable, highlighting the need for innovative therapeutic approaches like TALVEY™. The approval of TALVEY™ underscores Janssen's commitment to addressing the unmet needs of patients facing this complex hematologic malignancy. TALVEY™ is available under a restricted program known as the TECVAYLI® and TALVEY™ Risk Evaluation and Mitigation Strategy (REMS).
The study also documented non-hematologic adverse events, notably oral toxicities in 80 percent of patients, with 2.1 percent experiencing Grade 3 toxicity. The most common oral toxicities included dysgeusia, dry mouth, dysphagia, and ageusia. Additionally, 62 percent of patients encountered weight loss, with 29 percent experiencing Grade 2 weight loss and 2.7 percent experiencing Grade 3 weight loss. The study reported serious infections in 16 percent of patients, with 1.5 percent experiencing fatal infections. Grade 3 or 4 serious infections affected 17 percent of patients, while decreased neutrophil and platelet counts occurred in 35 percent and 22 percent of patients, respectively. Skin reactions were observed in 62 percent of patients, with 0.3 percent experiencing Grade 3 skin reactions. Approximately 9 percent of patients needed to discontinue TALVEY™ due to adverse reactions.