Treatment with Tecvayli (teclistamab-cqyv) for real-world patients with relapsed/refractory multiple myeloma demonstrated similar efficacy results and a comparable safety profile to findings among participants in the phase 1/2 Majes-TEC-1 trial, according to findings presented during the 2023 International Myeloma Society Annual Meeting.
Tecavayli is a type of drug that binds onto the protein CD3, which is found on a type of white blood cell, called a T cell. The drug also binds onto another protein, BCMA, found on myeloma cells. This helps the immune system to destroy cancer cells, according to National Cancer Institute.
The median progression-free survival (PFS, length of time after treatment when the disease does not worsen) was 4.7 months, with a median follow-up of 69.5 days. For patients who had received prior BCMA therapy, the median PFS was four months, compared with those who did not, which was 4.8 months.
“Our single-center retrospective experience of (Tecavayli) in (relapsed/refractory multiple myeloma) demonstrates similar efficacy and toxicity to the pivotal phase 2 MajesTEC-1 trial, despite 80% of our patients considered ineligible for trial inclusion,” lead study author Dr. Shonali Midha, medical oncologist from Dana-Farber Cancer Institute, said in a presentation during the meeting.
The trial’s main goal was to evaluate Tecavayli as a standard of care in the aforementioned patient population. To be included in the trial, patients must have the indicated disease and be treated with Tecavayli by Aug. 15, 2023. Additionally, patients who completed step-up dosing were considered evaluable for response. If patients died prior to the 30-day response from infection, Tecavayli toxicity or disease progression, they were included in the safety and survival analysis.
Responses were graded via the International Myeloma Working Group response criteria. Regarding adverse effects of cytokine release syndrome (CRS) and neurotoxicity, the American Society of Transplant and Cellular Therapy was managed by each institution.
In the MajesTEC-1 trial, 165 patients were given Tecavayli, the median follow-up was 14.1 months with an overall response rate (patients who have a partial or complete response to treatment) of 63% and a complete response of 39.4%. There was no minimal residual disease in 26.7% of patients, and the MRD-negativity rate of those with a complete response or better was 46%. Additionally, the median duration of PFS was 11.3 months.
Results from this trial helped lead to the approval of Tecavayli by the Food and Drug Administration in October 2022. The approval was the first for a BCMA-directed T-cell engager.
A total of 56 patients who received standard Tecavayli were evaluated, with a median age of 69 years. Most patients were male (62.5%), and 50% had an ECOG performance status of 1, meaning they are restricted in strenuous activity. The presentation noted that of the patients enrolled in this study, 45 (80%) would not have been eligible for treatment on the MajesTEC-1 trial. Additionally, the median number of prior lines of therapy was six.
Regarding safety, any-grade CRS occurred in 51.8% of patients treated with Tecavayli, with grade 3 or higher CRS occurring in 1.8%. The median time to onset of CRS was five days, and the median duration of the side effects was two days. Any-grade neurotoxicity occurred in 1.8% of patients. To manage these side effects, Actemra (tocilizumab) was used in 25% of patients with a median dose of one, and 12.5% used dexamethasone.
Infectious complications occurred in 57.1% of patients. A total of 48.4% of patients experienced grade 3 or 4 infectious complications; however, no deaths occurred. Infections complications included upper respiratory infection (37%), pneumonia (19%), gastrointestinal issues (13%), skin and soft tissue (13%), and viremia, bacteremia, and genitourinary issues (6% each). The median onset of these side effects was 31.5 days; COVID-19 comprised 45.5% of upper respiratory infections.
“Infectious complications remain a significant concern, nearly half requiring hospitalization and inpatient management,” Midha concluded.
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