With teclistamab-cqyv (Tecvayli) plus daratumumab and hyaluronidase-fihj (Darzalex Faspro; Tec-Dara) now holding a category 1 recommendation in the National Comprehensive Cancer Network Guidliness as a second-line option for relapsed/refractory multiple myeloma, community practices are confronting how to deliver bispecific antibodies safely outside the hospital and at a far larger scale than in later lines.1,2
"We are moving to outpatient treatment. That's the direction we need to go in a community setting, with tocilizumab [Actemra] prophylactically and seeing [these patients] on a daily basis, or [using] remote monitoring," Habte Yimer, MD, chair of hematology/oncology at Texas Oncology–CHRISTUS Trinity Mother Frances Hospital in Tyler, said during a recent OncLive® Scientific Interchange and Workshop.1
Yimer led the discussion with co-moderators Tiffiney McMakin, MSN, APRN, FNP-C, AOCNP, a nurse practitioner, and Jill Dickerson, BSN, RN, OCN, manager of nursing services, both of Texas Oncology–Tyler. Faculty included Phillip Chae, MD, of Texas Oncology–Midland Allison Cancer Center in Midland; Kurt Demel, MD, MBA, of HealthPartners in St. Paul, Minnesota; Yan Ji, MD, PhD, MS, of HealthPartners–Regions Hospital in St. Paul; Kimberly Ku, MD, of Illinois CancerCare in Bloomington; Priya Kumar, MBBS, MS, of HealthPartners Medical Group/Regions Hospital in St. Paul; Samir Mazharuddin, MD, of Texas Oncology–Kingwood in Humble; Stan Nabrinsky, MD, of Illinois Cancer Specialists in Elgin; Gordon Ruan, MD, head of the malignant hematology program at HealthPartners Frauenshuh Cancer Center in St. Paul; Robert Schneidewend, DO, MS, of North Memorial Health in Robbinsdale, Minnesota; and Brian Smith, MD, of SSM Health Cancer Care in Bridgeton, Missouri.
The panel worked through 2 cases: 1 on operationalizing bispecific antibodies at a community site and 1 on financial and coverage considerations.1
Bringing Bispecifics Home in Relapsed/Refractory Myeloma
- In the phase 3 MajesTEC-3 trial (NCT05083169), second-line Tec-Dara improved progression-free and overall survival across cytogenetic risk groups, but infection—not cytokine release syndrome or neurotoxicity—was the dominant safety concern.
- Prophylactic tocilizumab was the most frequently cited enabler of outpatient step-up dosing, and its inclusion in National Comprehensive Cancer Network guidelines has removed coverage as a barrier.
- Outpatient eligibility hinges on caregiver capacity and health literacy more than on comorbidity.
- Infusion chair time is the binding capacity constraint; a monthly bispecific committee cut observation times to roughly 50% of labeled durations.
- Hospital partnerships can be structured through handoff documents with baseline immune effector cell encephalopathy scores, shared calendars, and distribution lists.
- After-hours coverage, staff retention, and expansion to satellite sites remain unresolved gaps.
How is second-line Tec-Dara reshaping the bispecific landscape?
In the phase 3 MajesTEC-3 trial (NCT05083169), patients with relapsed/refractory multiple myeloma who received 1 to 3 prior lines of therapy were randomly assigned to Tec-Dara (n = 291) or daratumumab and dexamethasone plus either pomalidomide (Pomalyst) or bortezomib (Velcade; n = 296).3 At a median follow-up of 34.5 months, the 36-month progression-free survival (PFS) rate was 83.4% vs 29.7%, respectively (HR, 0.17; 95% CI, 0.12-0.23; P < .001); the 36-month overall survival rate was 83.3% vs 65.0%. These findings helped support the March 2026 FDA approval of the combination for for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy.4
Grade 3/4 infections occurred in 54.1% of patients in the Tec-Dara arm vs 43.4% in the control arm, whereas cytokine release syndrome (CRS; 60.1%) was predominantly low grade.3 Immune effector cell–associated neurotoxicity syndrome (ICANS) occurred in 1.1% of patients.3
"Infection is a major, a major problem—not CRS, not ICANS. It's infection. People died from infection in this study," Yimer said. “[Patients with multiple myeloma] are already at increased risk of infection, and bispecific T-cell engagers really increase that risk on top of the underlying immune suppression. [These patients need] to be on antiviral prophylactic medication [and] Pneumocystis jirovecii pneumonia prophylaxis with trimethoprim-sulfamethoxazole. If they’re [in a] later line [and] beaten up by transplant and multiple lines of therapy, you could cover them for fungal infection, but I don’t do that in early-line, second-line therapy.”
Yimer cited the larger patient population being treated in the second line vs the fifth line as a crucial reason for optimizing bispecific antibody administration outside of academic settings.5
"The number of [patients with] myeloma who you would be treating with bispecific therapy is going to go up 5 times as compared [with] 2025," he said. "Most of these patients in the second-line setting, they're fit, they're in relatively better shape than a fifth-line patient, and they should be able to be treated with bispecific therapy."
Can prophylactic tocilizumab make outpatient step-up dosing routine?
In the phase 2 OPTec/OPTal study (NCT05972135), patients who received prophylactic tocilizumab (n = 43) before the first step-up dose of teclistamab at community sites had a CRS rate of 5%, with all instances at grade 1, and no ICANS.6,7 In a University of Miami series of 119 patients treated with 4 bispecifics, a single prophylactic dose yielded a CRS rate of 10.1% and an ICANS rate of 5.9%.8 Earlier real-world outpatient or hybrid series, in which tocilizumab prophylaxis use was not reported, showed CRS rates of 26.8% (n = 71) and 61% (n = 23).9,10