Tocilizumab Supports Outpatient Bispecific Antibody Use in Multiple Myeloma

A single dose of prophylactic tocilizumab (Actemra) reduced the incidence of cytokine release syndrome (CRS) and supported the community-based outpatient administration of bispecific antibodies like talquetamab-tgvs (Talvey) and teclistamab-cqyv (Tecvayli) among those with relapsed/refractory multiple myeloma, according to a presentation on findings from the phase 2 OPTec/OPTal trial (NCT05972135) at the 2026 American Society of Clinical Oncology Annual Meeting (ASCO).

Among patients who received tocilizumab plus teclistamab in arm A or tocilizumab plus talquetamab in arm B, the overall response rate (ORR) was 68.9% and 71.4% in each respective arm. Across each treatment group, 6.7% vs 14.3% experienced a stringent complete response (sCR), 17.8% vs 14.3% had a CR, 26.7% vs 42.9% had a very good partial response (VGPR), and 17.8% vs 0% had a PR.

After a median follow-up of 11.8 months in arm A, 75.6% were free from disease progression; 24.4% had clinical or objective progression leading to end of therapy (n = 11). Additionally, 6 patients in arm A discontinued treatment before eventually dying due to progressive disease, with discontinuation attributable to adverse effects (AEs; n = 2), physician decision (n = 3), or withdrawal of consent (n = 1). No progression events had occurred to date in arm B.

There were no instances of Immune effector cell-associated neurotoxicity syndrome (ICANS) or grade 3/4 CRS across arms A and B. Data showed 6 CRS events in 4 of 45 patients (8.9%) who received teclistamab in arm A, which were all grade 1. Among patients who received talquetamab in arm B, there were 4 CRS events in 2 of 7 patients (28.5%) who were evaluable, which included 3 grade 1 events and 1 grade 2 event.

“We believe that [prophylactic tocilizumab] before teclistamab or talquetamab step-up dosing reduced the CRS rate to approximately 12.2%. We had 1 grade 2 [CRS] event that required hospitalization; no grade 3 [or higher] CRS or ICANS events were observed,” presenting study author Peter Forsberg, MD, from Colorado Blood Cancer Institute, stated in the presentation. “We believe that this supports an approach for administration of bispecific antibodies in the community-based outpatient setting using prophylactic tocilizumab, as well as the monitoring restrictions that were included in the trial.”

Investigators of the 2-arm, community-based OPTec/OPTal trial assessed the outpatient administration and step-up dosing monitoring for talquetamab and teclistamab in combination with prophylactic tocilizumab across 15 sites in the US. All patients received tocilizumab at 8 mg/kg on day 1 of treatment. In arm A, step-up dosing of teclistamab ranged from 0.06 mg/kg on day 1 to a full dose of 1.5 mg/kg, with weekly dosing taking place for up to 12 cycles. Patients in arm B received step-up dosing of talquetamab ranging from 0.01 mg/kg on day 1 to a full dose of 0.8 mg/kg, with dosing occurring biweekly for a maximum of 6 cycles.

The trial’s primary end point was the incidence of CRS from the first step-up dose to the end of cycle 2. Secondary end points included recurrent CRS or CRS within the first 12 months of teclistamab or 6 months of talquetamab, ORR per International Myeloma Working Group criteria, time to response, time to best response, duration of response, progression-free survival, and overall survival.

Patients 18 years and older with an ECOG performance status of 0 or 1; 2 or more prior lines of therapy including a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and/or CD38 antibody; and measurable disease at screening were eligible for enrollment. Other eligibility criteria included having a body weight of more than 35 kg, having stable clinical laboratory values, and being within 60 minutes of a treatment site during step-up dosing and the first full dose.

Regarding safety monitoring for outpatient administration of bispecific antibodies, investigators required patients to be within 60 minutes of a clinic and in the company of a competent adult for 48 hours after completing each step-up dose. Additional requirements included a 60-minute post-administration observation period after all doses for the first 2 cycles, daily investigator evaluations for 2 days after each step-up dose, home monitoring of temperature and oxygen saturation twice daily for the first 2 cycles, and neurological exams for the first 2 cycles.

Among 45 evaluable patients in arm A and 7 in arm B, the median age was 74.0 years (range, 53-87) and 66.0 years (range, 58-83), respectively. Across each respective arm, most patients were male (55.6% vs 57.1%), White (71.1% vs 71.4%), and most had an ECOG performance status of 1 (77.8% vs 71.4%). Most patients in each respective arm had prior exposure to an IMiD (93.3% vs 100%), a PI (97.8% vs 100%), and a CD38 monoclonal antibody (93.3% vs 100%). The median prior lines of treatment was 5.0 (range, 1-11) in arm A compared with 6.0 (range, 2-9) in arm B.

Additional safety data showed that the most common AEs across both arms included diarrhea (50%), nausea (35%), neutropenia (33%), fatigue (29%), cough (27%), and headache (27%). The most common grade 3 or higher toxicities in both arms included neutropenia (n = 13), sepsis (n = 4), and anemia (n = 4). There was 1 fatal toxicity—an instance of sepsis—in a patient who received treatment in arm A.

Of note, infections of any grade occurred in 51.1% of patients in arm A and 71.4% of those in arm B. Grade 3 or higher infections were reported in 17.8% and 28.6% of patients, respectively.

According to Forsberg, the trial has opened arm C to evaluate whether prophylactic oral dexamethasone may enable safe, community-based, outpatient treatment with teclistamab.

Disclosures: Forsberg noted consulting or advisory roles with Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Kite/Gilead, Legend Biotech, Pfizer, and Sanofi; serving on the Speakers’ Bureau for Sanofi; and receipt of research funding from AbbVie (Inst), Johnson & Johnson (Inst), and Kite/Gilead (Inst).

Reference

Forsberg P, Andorsky D, Rifkin RM, et al. Optec/Optal: a phase 2 study to evaluate outpatient (OP), step-up administration of teclistamab (Tec) or talquetamab (Tal) with prophylactic tocilizumab (prophyToci) in patients (pts) with relapsed/refractory multiple myeloma (RRMM). J Clin Oncol. 2026;44(suppl 16):7510. doi:10.1200/JCO.2026.44.16_suppl.7510