Experimental cancer therapy shows success in
New York, NY (December 10, 2022) — A new therapy that prompts the immune system to kill bone marrow cancer cells was successful in as many as 73 percent of patients in two clinical trials, according to researchers at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.
The therapy, known as bispecific antibodies, binds to both T cells and multiple myeloma cells and directs the T cells – white blood cells that can be involved in fighting the disease – to kill the multiple myeloma cells. The researchers described this strategy as “bringing your army right to the enemy.”
The success of the off-the-shelf immunotherapy, called talquetamab, was even seen in patients whose cancer was resistant to all approved multiple myeloma therapies. It uses a different target than other approved therapies: a receptor expressed on the surface of cancer cells known as GPRC5D.
Talquetamab was tested in phase 1 and phase 2 trials. The phase 1 trial, which was published in New England Journal of Medicine (NEJM), established two recommended doses that were tested in a phase 2 trial. The results of the phase 2 trial were announced at the annual meeting of the American Society of Hematology on Saturday, December 10. All study participants had previously been treated with at least three different therapies without achieving sustained remission, suggesting that talquetamab could offer new hope for patients with difficult-to-treat multiple myeloma.
“That means nearly three-quarters of these patients are looking for a new lease on life,” said Ajai Chari, MD, director of clinical research in the Multiple Myeloma Program at Tisch Cancer Institute and lead author of both studies. “Talquetamab produced a significant response among patients with previously intensively treated, relapsed or refractory multiple myeloma, the second most common blood cancer. It is the first bispecific agent that targets the GPRC5d protein in patients with multiple myeloma.”
Almost all myeloma patients who consistently receive standard therapy relapse. Patients who relapse or become resistant to all approved multiple myeloma therapies have a poor prognosis, therefore additional treatments are urgently needed. This study, although an early phase trial designed to detect tolerability and find a safe dose, is an important step in meeting that need.
This phase 1 clinical trial enrolled 232 patients at several cancer centers worldwide between January 2018 and November 2021. Patients received different doses of the therapy either intravenously or injected under the skin; future studies will focus on doses given just under the skin, either weekly or every other week
The efficacy and safety findings in the phase 1 study were confirmed in the phase 2 trial presented at ASH. The phase 2 trial included 143 patients treated with the weekly dose and 145 patients treated with the higher biweekly dose.
The overall response rate in the two groups was about 73 percent, Dr. Chari said. The response rate was maintained in the different subgroups examined, with the exception of patients with a rare form of multiple myeloma that also extends to organs and soft tissues. More than 30 percent of patients in both groups had a complete response (no detection of myeloma-specific markers) or better, and nearly 60 percent had a “very good partial response” or better (indicating that the cancer was significantly reduced but not necessarily reduced to zero).
The median time to measurable response was approximately 1.2 months in both dose groups, and the median duration of response to date is 9.3 months with weekly dosing. The researchers are continuing to collect data on the duration of response in the 0.8 mg/kg every other week group and for patients in both groups who had a complete or better response.
Side effects were relatively common, but usually mild. About three-quarters of patients experienced cytokine release syndrome, a constellation of symptoms including fever that is common with immunotherapy. About 60 percent experienced skin-related side effects such as rashes, about half reported taste changes, and about half reported nail disorders. The researchers said very few patients (5 to 6 percent) stopped taking talquetamab because of side effects.
The response rate seen in the study, which Dr. Chari explained was higher than the rate for most currently available therapies, suggests that talquetamab may offer a viable option for patients whose myeloma has stopped responding to most available therapies, offering an opportunity to extend life and the benefit of other new and future therapies as they are developed.
These trials were sponsored and funded by Janssen.
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