Robert Rifkin, MD Sarah Cannon Research Institute; Rocky Mountain Cancer Centers, discusses data from a phase 2 trial, indicating that prophylactic tocilizumab prior to outpatient step-up dosing of teclistamab may mitigate the risk of cytokine release syndrome (CRS) among patients with relapsed/refractory (R/R) multiple myeloma (MM).

These results, including the full safety cohort, were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Transcript:

Hello, I'm Dr. Robert Rifkin. I'm a medical oncologist at Rocky Mountain Cancer Centers in Denver, Colorado. In addition, I'm a member of the Sarah Cannon Research Institute at Rocky Mountain Cancer Centers and a member of the Multiple Myeloma Executive Committee. It's my pleasure to be able to share with you the findings of our poster presented at this year's ASCO.

It's an exciting development in [the] treatment of multiple myeloma. As everybody knows, bispecific antibodies have now [consumed] a huge part of the spotlight in the therapy of myeloma, with CAR T-cells and other cellular therapies very close behind. The study that we're going to present this time helps us to improve patient access and patient care.

More specifically, we're doing a study where a bispecific antibody teclistamab, which normally requires hospitalization, is going to be given completely as an outpatient. In order to do that, we're doing a relatively unique strategy by administering drugs to prevent cytokine release [syndrome] (CRS), or certainly delay the grade of cytokine release [syndrome]. The way we're going to do it is with a combination of prophylactic tocilizumab, which is an IL-6 blocking agent, some Tylenol, some Benadryl, and some steroids, with the idea of stopping all of that.

In addition, the first part of this study is a little bit unique, in that we'll be doing extensive pharmacokinetic-pharmacodynamic (PKPD) studies to be sure that the tocilizumab does not degrade the effectiveness of the teclistamab. So far, we've treated our first 10 patients. Those results will be presented here at ASCO. I'm proud to report that thus far, we have a zero incidence of cytokine release [syndrome] and a zero incidence of immune effector cell-associated neurotoxicity syndrome (ICANS) or neurotoxicity.

A lot of centers are doing this sort of off protocol as part of a treatment plan, but it's our aim of the study to really evaluate the bispecific antibody exactly according to the FDA label, and then come up with a strategy that makes it safe and effective. In addition to looking at CRS, we're also looking at the incidence of infections. As everybody knows, B-cell maturation antigen (BCMA) targeted agents, especially the bispecifics, have an increased incidence of infection.

As part of our study, when your immunoglobulin G (IgG) level falls below 400, you're getting intravenous immunoglobulin therapy, in addition to standard antibiotic prophylaxis. And we're just now really beginning to see the infections. And very early on, we have excellent responses to the bispecific antibody.

It's our hope by doing this according to label that we'll create a very nice practice-changing plan and then be able to administer this, I hope, exclusively in the outpatient setting.

Source:

Rifkin R, Schade H, Simmons G, et al. OPTec: A phase 2 study to evaluate outpatient (OP) step-up administration of teclistamab (Tec), a BCMA-targeting bispecific antibody, in patients (pts) with relapsed/refractory multiple myeloma (RRMM). Presented at the ASCO Annual Meeting. May 31–June 4, 2024; Chicago, IL. Abstract 7528