Janssen's bispecific antibody drug for multiple myeloma wins nod in Korea

Janssen Korea said Tuesday it has received approval from the Ministry of Food and Drug Safety for the multiple myeloma treatment Talvey Inj. (talquetamab).

The indication for domestic approval is monotherapy for adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies.

Talvey is the first bispecific antibody targeting the CD3 receptor and GPRC5D approved in Korea for multiple myeloma. It is an off-the-shelf drug ready to be administered to patients.

The approval is based on the MonumenTAL-1 study, which evaluated Talvey 0.4 mg/kg weekly or 0.8 mg/kg biweekly in patients who had failed or been refractory to three or more prior therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies, Janssen Korea said.

In the study, 143 patients with no prior T-cell reintroduction therapy received 0.4 mg/kg weekly, which was analyzed for an overall response rate (ORR) of 74.1 percent (95 percent CI, 66.1-81.1 percent) and a strict complete remission (sCR) rate of 24 percent. Complete remission (CR) and very good partial remission (VGPR) were achieved in 10 percent and 26 percent of patients.

A total of 145 patients who had not received prior T-cell reintroduction therapy and received 0.8 mg/kg biweekly were analyzed, with an ORR of 71.7 percent (95 percent CI, 63.7-78.9 percent), and 30 percent achieved a strict complete remission. Complete remission and very good partial remission were achieved in 9 percent and 22 percent.

The most common adverse events in the MonumenTAL-1 study (≥20 percent) were cytokine release syndrome (CRS), taste abnormalities, hypogammaglobulinemia, nail disorders, musculoskeletal pain, anemia, fatigue, skin disorders, weight loss, rash, dry mouth, neutropenia, pyrexia, xerostomia, thrombocytopenia, upper respiratory tract infection, lymphopenia, diarrhea, dysphagia, pruritus, cough, decreased appetite, pain, and headache.

Serious adverse reactions reported in 2 percent or more of patients included cytokine release syndrome (CRS), pyrexia, immune effector cell-associated neurotoxicity syndrome (ICANS), sepsis, Covid-19, bacterial infection, pneumonia, viral infection, neutropenia, and pain. The most common adverse events leading to treatment discontinuation were immune effector cell-associated neurotoxicity syndrome (1.1 percent) and weight loss (0.9 percent).

Multiple myeloma, known as the "blood cancer of the elderly," is a cancer whose incidence has increased by more than 60 percent in the last decade, and many patients experience relapse. In one cohort study, multiple myeloma patients treated with three or more therapies, including anti-CD38 monoclonal antibodies, had an ORR of 30 percent or less, resulting in a short life expectancy and poor prognosis.

"We are pleased to be able to offer the first bispecific antibody therapy with a mechanism targeting GPRC5D in Korea with this approval for Talvey," said Kim Yeon-hee, Oncology Business Unit Director at Janssen Korea. "Multiple myeloma requires multiple treatment options due to frequent relapses and a high rate of treatment failure due to drug resistance. We will continue to take the lead in improving the treatment experience for patients."