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Publication|Articles|October 23, 2026

In Chicago, Academic Centers Weigh What It Will Take to Hand Off Bispecifics to the Community

Author(s)Mary Caffrey

Clinicians from University of Chicago Medicine, Northwestern Medicine, and Loyola Medicine said bispecific antibodies for early-relapse myeloma can be given safely outside the hospital, but staffing, after-hours triage, and community confidence have yet to catch up.

Bispecific antibodies are moving into the second line of multiple myeloma treatment faster than health systems can build the infrastructure to deliver them, according to clinicians from 3 Chicago academic centers who gathered September 17, 2026, for a Stakeholder Interchange presented by The American Journal of Managed Care.®

The discussion was moderated by Sandeep Parsad, PharmD, MBA, BCOP, executive director of pharmacy at University of Chicago (UChicago) Medicine, who oversees the cancer service line, including ambulatory infusion and investigational drug services. Also from UChicago were Kaitlin Kelly, PharmD, MHS, a clinical pharmacist in myeloma and lymphoma, and Rachel Malloy, DNP, RN, CNRN, SCRN, a nurse navigator with the myeloma group. From Northwestern Medicine were Divya Khandekar, PharmD, MS, BCOP, inpatient lymphoma and myeloma pharmacist at Northwestern Memorial Hospital; Melissa Tumpich, APRN, MSN, outpatient advanced practice provider manager for stem cell transplant and myeloma; and Suzanne Dwyer, PharmD, BCOP, the first in-clinic myeloma pharmacist at Northwestern Medicine. Sanja Zepcan, PharmD, BCPS, BCOP, hematology/oncology and cellular therapy pharmacist at Loyola University Medical Center, completed the panel.

Guidance on Bispecifics Is Moving at Rapid Pace

As she moved through the session slides, Parsad said the field is moving so quickly it’s hard to keep materials current. FDA approved teclistamab (Tecvayli) plus daratumumab (Darzalex), both from Janssen, in March 2026 for patients with at least 1 prior line of therapy.¹ The June 2026 update of the American Society of Clinical Oncology (ASCO) living guideline lists teclistamab plus daratumumab as a preferred option at first relapse for patients who have not received B-cell maturation antigen (BCMA)–directed therapy, and it also names ciltacabtagene autoleucel, or cilta-cel (Carvykti; Johnson & Johnson) as a preferred option in eligible BCMA-naive patients.²

Parsad then drew attention to what the guideline does not say about sequencing. “They emphasize that evidence is insufficient to establish a preferred sequence. That’s different than saying they’re equally preferred,” she said. “We just don’t know yet.” Payers, she warned, may seize on language suggesting all options are interchangeable.

The trials behind the shift were both striking. MajesTEC-3 (NCT05083169), presented at the American Hematology Society annual meeting in December 2025, led to the combination’s approval and showed 83.4% of patients receiving teclistamab plus daratumumab were progression free at 3 years.³ MajesTEC-9 (NCT05572515), presented at ASCO in May 2026, showed an 18-month progression-free survival (PFS) rate of 69.8% with teclistamab monotherapy, vs 26.9% with standard regimens, in patients with 1 to 3 prior lines, most of whom had received anti-CD38 therapy.⁴ Parsad said MajesTEC-9 also reinforced the infection risk: grade 3/4 infections occurred in 41.6% of patients receiving teclistamab.⁴

In the earlier MajesTEC-1 trial, cytokine release syndrome (CRS) occurred in 72% of patients, and immune effector cell–associated neurotoxicity syndrome (ICANS) occurred in 3%.⁵ MonumenTAL-3, published in June 2026, showed a 2-year PFS rate of 77.6% with talquetamab (Talvey; Janssen) plus daratumumab, vs 51.2% with daratumumab plus pomalidomide (Pomalyst; Bristol Myers Squibb) and dexamethasone.⁶

Fewer patients remain eligible for treatment at each relapse,⁷ with estimates showing a 5.4-fold increase in patient volume when bispecifics move from the fifth line to the second.8 “These numbers are not going down,” Parsad said.

Kelly said UChicago remains primarily a cilta-cel center, but delayed neurotoxicity with chimeric antigen receptor (CAR) T-cell therapy has the team asking more often whether a bispecific is the better choice. Because nearly all patients now receive daratumumab up front, she said, the MajesTEC-3 population does not fully reflect UChicago’s patients, which frequently makes teclistamab monotherapy a consideration.

T-Cell Exhaustion and the Sequencing Problem

Several panelists said their biggest unanswered question is what repeated T-cell–directed therapy does to patients’ later options. Zepcan said Loyola generally avoids giving a second BCMA-directed therapy immediately after the first, inserting a treatment with a different mechanism in between. Kelly said UChicago avoids talquetamab when it can because of its oral and skin toxicities, and Dwyer said many patients do not want to stay on it long term.

“If you’re putting people on sequential BCMAs or BCMA followed by the talquetamab, I’m just really worried what we’re doing to those T-cells without having a really good option to support them on the back end,” Dwyer said. She and Parsad were optimistic about a new class of therapy, cereblon E3 ligase modulators (CELMoDs). FDA granted accelerated approval to the first, iberdomide (Zenbexus; Bristol Myers Squibb), with daratumumab and dexamethasone in August 2026.⁸

Khandekar said the decision at first relapse has become a fork in the road. “So, it’s either [autologous], it’s either CAR T, or it’s either bispecifics,” she said. “I think we are essentially putting people into 3 different buckets.” Parsad noted that for community patients, the CAR T bucket often does not exist.

Step-Up Dosing Departs From the Label

Participants from each of the centers said they modify the labeled step-up schedules. Zepcan said Loyola follows the package insert for inpatients but not for outpatients, who come to clinic daily for laboratory monitoring instead of staying 48 hours. For inpatients, Loyola gives teclistamab step-up doses on days 1, 3, and 5, rather than the labeled schedule.⁹ UChicago builds outpatient teclistamab step-up dosing around clinic days. Kelly said the team has also given linvoseltamab (Lynozyfic; Regeneron) to selected patients without the 24-hour hospitalization the label calls for after the first 2 step-up doses.¹⁰

Dwyer said Northwestern does not keep patients for observation after bispecific injections, as it does for CAR T. Kelly concurred, noting that fever typically arrives approximately 48 hours after a dose, so dose timing matters more than time in the chair. Malloy said other academic centers have cut back from daily visits to every other day as they gained experience.

Parsad said community data support outpatient administration, even if the numbers are small. In a Cardinal Health network analysis of 71 patients who started teclistamab in outpatient or hybrid settings, CRS occurred in 26.8% during step-up dosing (2.8% grade 3) and ICANS in 4.2%.¹¹ Within the OneOncology network, 70% of patients who began step-up dosing as outpatients completed it without hospitalization.¹² European recommendations published in 2026 limit outpatient step-up dosing to patients with low tumor burden and a trained caregiver who live within 60 minutes of an inpatient facility.¹³ Northwestern’s outpatient criteria use the same 60-minute threshold; again, this is measured in travel time rather than miles.

Parsad said the unsolved piece is after-hours coverage. “Who’s going to answer the call at 2:00 in the morning?” she asked, adding that pharmacists and nurses cannot absorb it informally. “You actually need a committee, and you need a group that does this.”

Northwestern recently opened an outpatient cellular therapy unit with nocturnists trained on a dedicated call line. Tumpich said Northwestern had approximately 90 new bispecific starts the previous year, with all patients admitted; at the time of the interchange, its first outpatient step-up patient was scheduled for October. UChicago plans to expand its Oncology Rapid Assessment Clinic when a new cancer center opens in April 2027, but Malloy said the clinic is already “extremely overbooked and understaffed.”

Community Partners: Willing in Lymphoma, Wary in Myeloma

Dwyer said some of Northwestern’s community partners decline bispecifics entirely, even for maintenance doses, citing a lack of staffing or a 24-hour call line. Kelly has seen a different pattern. “I’ve seen it where they’ll do the lymphoma bispecifics, but they won’t take on the myeloma bispecifics when it’s very similar, like outside of that CRS and [neurotoxicity],” she said.

The result is long trips for patients. “I do have one patient in particular that travels an hour and a half every week for his,” Malloy said. “There’s nothing closer for him, which is really unfortunate.”

Khandekar said “the limiting step is not having enough providers in the community” with myeloma experience. Zepcan argued for keeping step-up dosing at academic centers until community sites gain experience. She described a patient transferred to Loyola after grade 3 or possibly grade 4 CRS whose community team had called the bispecific contraindicated. The Loyola team rechallenged the patient once stable, and treatment continued. “That level of expertise sometimes is needed for [the] patient to be safely put through the initial phase,” Zepcan said.

Parsad said UChicago’s expansion into Crown Point and Chesterton, Indiana, required meetings with emergency department (ED) groups about stocking tocilizumab and recognizing CRS. He said the infrastructure should be negotiated at the executive level, “VP to VP,” rather than left to pharmacists and nurse practitioners. He also said partner sites need enough patient volume to keep their “muscle memory.”

Zepcan said manufacturers can help reach busy community oncologists. “When the time comes, we really would need, like, industry partners to help us with our education in community centers,” she said.

Prophylaxis: Tocilizumab and IVIG

Practice on prophylactic tocilizumab varied. Dwyer said Northwestern stopped giving it to every patient, largely because of insurance barriers, and relies on “pill in the pocket” dexamethasone. Zepcan said Loyola’s review of early tocilizumab at the first sign of CRS, vs prophylactic tocilizumab, found little difference in outcomes. Kelly said UChicago uses it selectively, often at a lower dose. The group agreed the calculus shifts in community settings far from an ED. Published data support the strategy: in the community-based OPTec study, 8.9% of 45 patients receiving teclistamab developed CRS, all grade 1,¹⁴ and a University of Miami series of 119 patients reported CRS in approximately 10%.¹⁵ An economic model found outpatient step-up dosing with prophylactic tocilizumab cost approximately $8800 less per patient than inpatient teclistamab dosing.¹⁶

Dwyer said prophylactic tocilizumab was easy to get approved for heavily pretreated Medicare and Medicaid patients but could be harder for younger, commercially insured patients in the second line.

Immunoglobulin replacement drew more agreement. Kelly said UChicago now gives primary prophylaxis with a flat 10g dose of intravenous immunoglobulin (IVIG). Zepcan said Loyola orders IVIG along with the bispecific, gives the first dose before cycle 1, and targets an IgG level of approximately 500 mg/dL. Kelly said payers have recently demanded 2 IgG readings below 400 mg/dL. Parsad noted that home infusion can be a practical workaround when clinic chairs are scarce.

Payers, Appeals, and an Assist From AI

Kelly said one payer would approve teclistamab plus daratumumab but not teclistamab alone for a patient already refractory to daratumumab, so the team requested the combination and held the daratumumab. In another case, a union-sponsored health plan denied CAR T outright for a young, fit patient, forcing a switch to a bispecific.

Tumpich, whose team handles appeals and peer-to-peer reviews, said most denials stem from payer mistakes. “It’s mostly an insurance error because they’re not reading our notes properly,” she said, and the result “delays their treatment immensely.” She said the artificial intelligence (AI) tool OpenEvidence has helped: “They’ll help write appeal letters and even your peer-to-peers on the phone, which is very helpful when you plug in the patient info.”

Remote monitoring raised its own issues. “We’ve all seen a blood pressure cuff: one has one button and one has 20 buttons,” Dwyer said, so patients should train on the same kit they take home. She described one patient who could not do video visits because he had only a flip phone.

Parsad said UChicago, a 340B hospital, has a strong financial reason to move administration to the clinic. Zepcan said the FDA’s May 2026 change to the teclistamab and talquetamab REMS dispensing requirements should ease the burden on community pharmacies.¹⁷

Parsad closed with a call for shared guidelines as the agents move earlier. “We can’t just leave it wide open,” he said.

References

  1. Johnson & Johnson announces US FDA approval of Tecvayli plus Darzalex Faspro for relapsed refractory multiple myeloma offering a potential new standard of care as early as second line. News release. Johnson & Johnson. March 5, 2026. Accessed October 22, 2026. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-tecvayli-plus-darzalex-faspro-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care-as-early-as-second-line
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  9. FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma. FDA. August 13, 2026. Accessed October 22, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone
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  13. Raff L. Outcomes of outpatient step-up dosing (SUD) of teclistamab and talquetamab in patients with relapsed/refractory multiple myeloma (RRMM): findings from a large network of community practices in the USA. Presented at: 22nd Annual Meeting of the International Myeloma Society; September 17-20, 2025; Toronto, Ontario, Canada. Abstract PA-057.
  14. Mateos MV, Zamagni E, Gentile M, et al. European recommendations for transitioning the care of patients with multiple myeloma treated with B-cell maturation antigen bispecific antibodies from academic hospitals to community-based centers and for outpatient step-up dosing. EJHaem. 2026;7(3):e70290. doi:10.1002/jha2.70290
  15. Caffrey M. Results show giving prophylactic tocilizumab reduces CRS in outpatient delivery of teclistamab, talquetamab. AJMC. June 1, 2026. Accessed October 22, 2026. https://www.ajmc.com/view/results-show-giving-prophylactic-tocilizumab-reduces-crs-in-outpatient-delivery-of-teclistamab-talquetamab
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  18. FDA. Supplement approval letter: BLA 761291/S-017 (Tecvayli) and BLA 761342/S-019 (Talvey), REMS modification. May 6, 2026. Accessed October 22, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761291Orig1s017,%20761342Orig1s019ltr.pdf

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