Prophylactic Measures and Access Gaps Define the Push to Deliver Bispecifics Closer to Home in Myeloma

Bringing bispecific antibody therapy “home” to community practices for the treatment of patients with relapsed/refractory multiple myeloma hingesless on the agents themselves; rather, management strategies including outpatient step-up dosing, caregiver support, hospital partnerships, and payer navigation are key factors for delivering these therapies outside of academic settings, expert faculty agreed at a recent OncLive^® Scientific Interchange and Workshop.¹

Co-moderated by Darren Pan, MD, and Nancy Wong, NP, MSN, both of the University of California, San Francisco (UCSF), the session paired the second-line data for bispecific antibody–based regimens with case-based discussions on their use.

“The difference between teclistamab-cqyv [Tecvayli] plus daratumumab [Darzalex] or these immunotherapy options and standard-of-care treatments isn’t so much whether you can get patients to respond; it’s how deep that response is and how long that response lasts,” Pan said.

How are community oncologists approaching second-line teclistamab plus daratumumab?

In March 2026, a bispecific antibody–based regimen was approved for use as early as the second-line setting, with the approval of teclistamab plus daratumumab for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy.²

In the phase 3 MajesTEC-3 trial (NCT05083169), which supported the approval, patients were randomly assigned to receive teclistamab plus daratumumab or daratumumab plus pomalidomide (Pomalyst) and dexamethasone (DPd) or daratumumab plus bortezomib (Velcade) and dexamethasone (DVd).³

At a median follow-up of 34.5 months, the teclistamab-based regimen yielded a statistically significant improvement in progression-free survival (PFS) compared with the control regimens (HR, 0.17; 95% CI, 0.12-0.23; P < .001). The 36-month PFS rates were 83.4% with teclistamab plus daratumumab vs 29.7% for the control combinations, and respective overall response rates were 89.0% vs 75.3%.

Although now approved, workshop faculty questioned how far the data translate to clinical practice in the United States, where frontline anti-CD38 monoclonal antibody exposure is near universal but was absent in a significant number of patients in MajesTEC-3.

That question of real-world applicability was the crux of the faculty’s debate. Ahmad Fora, MD, a medical oncologist in private practice in Olympia, Washington, noted that United States clinicians typically keep high-risk patients on frontline daratumumab maintenance rather than dropping it, meaning many would be daratumumab-refractory at relapse and fall outside the trial population. Pan’s counter turned on the distinction between daratumumab-exposed and daratumumab-refractory disease: because CD38 is re-expressed roughly 6 months after the last anti-CD38 dose, a patient whose daratumumab has lapsed is not equivalent to one experiencing progression while on active therapy. Pan contended the latter population is better served by teclistamab monotherapy at relapse. Although teclistamab monotherapy is not approved by the FDA in the first-relapse setting, the bispecific antibody improved PFS in a anti-CD38–refractory population in the phase 3 MajesTEC-9 trial (NCT05572515).⁴

“If they’re daratumumab exposed but they did not relapse while actively receiving daratumumab, those are patients that can benefit from [teclistamab plus daratumumab]. If they relapsed while actively receiving an anti-CD38 antibody, I would favor teclistamab by itself,” Pan said.

What does operationalizing outpatient step-up dosing require?

Along with highlighting the key efficacy data for bispecific antibody–based regimens, the panel of experts delved into the strategies that can help bring these types of agents to the community setting.

Prophylactic tocilizumab (Actemra) was cast as the intervention that makes community outpatient step-up feasible: a single dose hours before the first step-up dose—its roughly 1.5-week half-life spanning the window—drove CRS to 5% (all grade 1) in the community-based OPTec trial (NCT05972135) and to 10.2% across 119 patients at the University of Miami, with retrospective cohorts reporting 70% of patients completing step-up without hospitalization.^5-7

“We have been doing the step-ups, I would say, for the past year or so, which took a lot of educational activities, [including] training the intensivists and the nurses,” said Radhika Gali, MD, of a community practice in Medford, Oregon.

Where practices landed varied widely. Some now run both step-up and maintenance in-house, a larger group takes patients back only after an academic center handles the step-up, and others still refer out entirely. Notably, what most often kept a patient from stepping up as an outpatient was not the disease but the logistics of everyday life—whether a caregiver could be present around the clock, with stable housing and proximity to the clinic close behind.

To run step-up safely, clinics rely on a handful of concrete safeguards, including nurse check-ins with patients on days between doses, wearable devices to track vital signs at home, distribution of “pocket” dexamethasone to use at the first sign of fever, and a wallet card to ensure emergency department (ED) staff know that a patient is on a bispecific.

“We just have to do the first case, just like venetoclax [Venclexta] in the old days. We were so scared of venetoclax, tumor lysis, all the crises, but now we [administer] it every day,” said Xingyue He, MD, of Vancouver Clinic, framing CRS management as a learning curve that flattens with case volume.

The panel’s single largest request to manufacturers was a live clinical consultation line for staff to use during a practice’s first several cases of bispecific antibody administration.

“Being able to call a central line and say, ‘I’m interacting with this patient. They have these symptoms. What do you think is the best next step?’…would really go a long way [toward] providing comfort to staff members who have variable levels of experience,” said Vikramsinh Dabhi, MD, PhD, of a multispecialty group in Bothell, Washington.

How do financial and access pressures shape community use?

Coverage of the bispecific and of prophylactic tocilizumab has been largely frictionless, experts noted, with Pan reporting no denials since approval, and several panelists cited timely on-label approvals.

The more persistent reimbursement obstacle has been intravenous immunoglobulin (IVIG), which faculty administer to essentially all patients receiving bispecific antibodies at a dose of 0.5 g/kg every 4 weeks. Payers frequently deny coverage when a patient’s total IgG level is normal. To address this, faculty described several workarounds, including IgG subclass testing to document a functional deficiency, peer-to-peer review, home subcutaneous administration, and delivery at an independent infusion center rather than a hospital-affiliated one. Capitated and smaller commercial plans posed a separate challenge. Faculty reported that medical directors at these plans have called clinics directly to request less expensive regimens when daratumumab and a bispecific antibody are used together, and no panelist had a reliable way to navigate that pressure.

Capitated and smaller commercial plans posed a separate challenge, as their medical directors have called to request less expensive regimens when daratumumab and a bispecific antibody are used together—a barrier for which no faculty member offered a clear solution.

“The cost of inpatient admission is astronomical, so I think this would be a favorable thing for most capitated insurance plans, and the dual regimen may be cheaper than CAR T[-cell therapy],” said Sherry Hu, MD, PhD, of the Swedish Cancer Institute in Issaquah, Washington.

Nonetheless, the same outpatient model that keeps costs down can also limit access, because it assumes a patient has a caregiver, reliable transportation, and the ability to take time off work. Wei Bai, MD, of Mission Hope in Santa Maria, California, raised the equity issue directly, noting that some patients with unstable housing may be better served by staying in academic-center housing than by a community program.

“We send patients out to [an] academic center to get this more…advanced treatment, like bispecifics or CAR T. We are not getting patients back. That’s kind of the challenge we face,” Bai said. “To a certain extent, I even feel like this treatment is more for…affluent communities.”

What unmet needs did the panel identify?

The panel’s through-line was access, not efficacy. Even with second-line approvals for both a bispecific antibody–based therapy and CAR T-cell therapy, most patients still receive no immunotherapy in the second or even third line, with the caregiver, time-off, and proximity demands of outpatient models disproportionately excluding patients from underserved communities. Faculty also named label-adherent dosing, under-reimbursed IVIG, manufacturer consultation lines, and ED readiness as gaps warranting education.

“We are a group of 18. I think 3 or 4 of us have a little bit [of] experience [with bispecific antibodies], but everybody else does need education,” said Nihal Abdulla, MD, of Cancer and Blood Specialty Clinic in the Long Beach, California, area. “We have an on-call group, so we don’t have an answering service, so it does come to us.”

Pan closed by urging earlier referral: not every patient reaches a third, fourth, or fifth line of therapy, and immunotherapy works best while the immune system remains in better condition.

References

1. Bringing bispecifics home: practical considerations for outpatient and community integration in relapsed/refractory multiple myeloma. An OncLive Scientific Interchange and Workshop. OncLive. July 29, 2026. Accessed August 25, 2026.
2. FDA grants third approval under the national priority voucher program. FDA. March 5, 2026. Accessed August 25, 2026. https://www.fda.gov/news-events/press-announcements/fda-grants-third-approval-under-national-priority-voucher-program
3. Costa LJ, Rodriguez-Otero P, Bahlis NJ, et al. Teclistamab plus daratumumab in relapsed or refractory multiple myeloma. N Engl J Med. Published online December 9, 2025. doi:10.1056/NEJMoa2514663
4. Mina R, Touzeau C, Hungria V, et al. MajesTEC-9: a phase 3 randomized study of teclistamab monotherapy vs investigator’s choice of pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone (PVd/Kd) in patients (pts) with relapsed refractory multiple myeloma (RRMM). J Clin Oncol. 2026;44(suppl 16):7507. doi:10.1200/JCO.2026.44.16_suppl.7507
5. 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
6. Kowalski A, Lykon J, Diamond B, et al. Tocilizumab prophylaxis for patients with multiple myeloma treated with bispecific antibodies. Blood Adv. 2025;9(19):4979-4986. doi:10.1182/bloodadvances.2025016911
7. Dhakal B, Ko G, He J, et al. Outcomes of teclistamab (Tec) step-up dosing in outpatient/hybrid settings among a large sample of relapsed refractory multiple myeloma (RRMM) patients treated with Tec. Presented at: 22nd Annual International Myeloma Society Meeting and Exposition; September 17-20, 2025; Toronto, Canada. Abstract 023.