Myeloma treatment shows lasting benefits for hard-to-treat disease

Most myeloma patients taking Tecvayli (teclistamab-cqyv) were alive and free from disease progression two years after starting treatment, according to a new analysis of more than two dozen patients who received the drug as part of a clinical trial in China.

“After more than 2 years of median follow-up, [Tecvayli] continued to demonstrate clinically meaningful benefit in [hard-to-treat myeloma] patients,” the researchers wrote.

The study, “Efficacy and Safety of Teclistamab in Relapsed/Refractory Multiple Myeloma: 2-Year Follow-Up From MajesTEC-1 China Cohort,” was published in eJHaem. The work was funded by Johnson & Johnson, which markets Tecvayli.

Myeloma is caused through the abnormal growth of certain immune cells. Tecvayli works by simultaneously binding to BCMA, a protein expressed by myeloma cells, and CD3, a protein expressed by cancer-killing immune cells called T-cells. By binding both simultaneously, the therapy essentially helps direct the immune system to eliminate cancer cells.

Tecvayli is approved in the U.S. and elsewhere to treat certain people whose disease has not responded adequately to prior myeloma treatments. Approvals were based mainly on a clinical trial program called MajesTEC-1, which consisted of a Phase 1/2 study (NCT03145181) followed by a larger Phase 2 study (NCT04557098).

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Analyzing long-term outcomes

In this analysis, researchers presented long-term outcomes from 26 myeloma patients who participated in the MajesTEC-1 program as part of a cohort study in China. These patients ranged in age from 42 to 84. All had previously received at least three lines of treatment; most had received five or more.

In the trial, all 26 patients started Tecvayli at a dose of 1.5 mg/kg, administered by injection under the skin once weekly. Patients could switch to less frequent dosing if they responded well to the treatment. They were treated for a median of about 10 months.

At the time of the analysis, the median follow-up time was more than 27 months (slightly longer than two years). Results showed roughly three-quarters (76.9%) of participants responded to treatment, meaning their cancer burden decreased. Most patients who responded achieved a complete response, basically meaning they did not have detectable cancer. After more than two years of follow-up, most patients (60%) were still in response, with longer response times generally observed in those with a complete response.

At two years, 75.1% of patients were alive, and more than half (56%) of all patients were also free from disease progression. Based on available data, at 2.5 years the estimated progression-free rate was 43.6% overall, reaching 80% among patients who achieved a complete response. The researchers noted that treatment response and survival outcomes were generally comparable regardless of traditional prognostic indicators at the start of the trial.

“These findings, together with the results from the MajesTEC‑1 pivotal cohort, reinforce that [Tecvayli] continues to deliver deep and durable responses in heavily pretreated [myeloma] patients,” the researchers wrote.

About half of the participants reported notable improvements in physical functioning, fatigue, and/or pain after several months of Tecvayli treatment.

These patient-reported outcomes “demonstrated sustained improvements in global health status, physical functioning, fatigue, and pain among patients treated with [Tecvayli],” the researchers wrote. “These observations align closely with findings from the MajesTEC‑1 pivotal cohort, reinforcing the consistency of health-related quality-of-life (HRQoL) benefits across studies.”

“By inducing deep and durable responses, [Tecvayli] may mitigate disease burden and its associated symptoms, thereby translating effective biological disease control into meaningful symptomatic and functional improvements,” they added.

Safety data were overall consistent with the known profile of Tecvayli: Low immune cell counts and serious infections were reported in most patients. The researchers noted that serious infections became less common over time, which coincided with patients switching to less frequent dosing schedules and likely reflected increased use of preventive treatments to reduce the likelihood of infection in at-risk patients.

“Overall, these results reinforce [Tecvayli] as an effective and manageable SOC for heavily pretreated [myeloma] patients in China,” the researchers concluded.