Hematologists with Vanderbilt-Ingram Cancer Center have published strategies for implementing outpatient treatment programs for bispecific antibodies, an immunotherapy that can cause adverse reactions.

The recommendations, published recently in JCO Oncology Practice, detail a comprehensive overview of the potential risks, treatment options for dealing with reactions, prophylactic protocols to prevent them from occurring, and the roles of an interdisciplinary care team within an outpatient program. The team at Vanderbilt-Ingram has expertise in outpatient care models for immunotherapy treatment because Vanderbilt-Ingram was among the first in the nation to establish outpatient protocols for another personalized immunotherapy, CAR-T.

Bispecific antibodies (BsAb) utilize engineered antibodies, molecular spikes, which bind to both cancer cells and immune cells, activating a patient’s T cells to attack hematologic malignancies. With CAR-T (chimeric antigen receptor T-cell therapy), T cells are harvested from a patient, then reengineered to recognize and destroy cancer cells before being infused back into the patient’s body. Both therapies can elicit strong immune responses with complications that pose risks, including cytokine release syndrome, a potentially life-threatening reaction that can damage healthy tissues and organs.

For this reason, the BsAb and CAR-T therapies typically require inpatient monitoring, which can be an economic and logistical burden for both patients and hospitals.

“Bispecific antibodies are a major advance in the field of cancer immunotherapy,” said the article’s corresponding author, Bhagirathbhai Dholaria, MBBS, associate professor of Medicine. “This class of drugs is available off the shelf, which makes them ideal for utilization in the community settings. In this article, we have provided a comprehensive framework to establish an outpatient bispecific antibodies program, especially for community practices, which do not have an already established CAR-T program. Our strategy has the potential to greatly reduce the logistical and financial burden during step-up dosing of bispecific antibodies while maintaining safety of the patients.”

The protocols suggested are for seven BsAb therapies that have been approved by the Food and Drug Administration for non-Hodgkin lymphoma and multiple myeloma. They address potential complications, including cytokine release syndrome, infections, cytopenia, tumor flare reactions, and immune effector cell-mediated neurotoxicity syndrome.

The authors noted that while outpatient programs for CAR-T were established before bispecific antibodies, CAR-T poses higher risks for adverse reactions. Their recommendations prioritize early recognition and intervention for these complications, particularly in the first cycle of treatment with BsAb when most cytokine release syndrome events are likely to occur.

The paper provides an infrastructure and workflow guide for how clinicians can work with patients to implement monitoring and address care needs. They also stress the importance of educating both patients and family/friend caregivers about proper protocols for remote monitoring.

The article’s additional authors are Kian Rahbari, MD, and Raul del Toro Mijares, MD, Kathryn Kennedy, RN, Leslie Mader, RN, Salyka Sengsayadeth, MD, Reena Jayani-Kosarzycki, MD, James Jerkins, MD, Andrew Jallouk, MD, Tae Kon Kim, MD, Shakthi Bhaskar, MD, Vivek Patel, MD, Brittney Baer, RN, Sarah Moseley, RN, David Morgan, MD, Bipin Savani, MD, Adetola Kassim, MD, Muhamed Baljevic, MD, and Olalekan Oluwole, MD.

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Some cancer patients experience durable remissions from immune checkpoint inhibitors that spur their T cells to attack cancer cells, but these immunotherapies can also cause reactions.

One of the adverse effects of these treatments is skin reactions known as cutaneous immune-related adverse events (cirAEs), although it is not known how often they morph into a chronic condition. Research led by investigators at Vanderbilt University Medical Center published in JAMA Dermatology provides insight into chronic cirAEs. They recommended long-term follow-up for patients by dermatologists familiar with cirAEs and consideration of corticosteroid-sparing treatment options.

“Understanding the potential for side effects to become long-lasting has been an important advance recently, and managing them more effectively is a key unmet need,” said the study’s corresponding author, Douglas Johnson, MD, MSCI, professor of Medicine, holder of the Susan and Luke Simons Directorship, and co-leader of the Translational Research and Interventional Oncology Research Program at Vanderbilt-Ingram Cancer Center.

The investigators reviewed the records of 318 patients from a previous study who had been treated with immune checkpoint inhibitors. Of that number, 100 or 31% developed cirAEs with the skin conditions becoming chronic for 24 of the patients — nearly 8% of the full cohort. The study looked at 21 of those patients who underwent detailed follow-up. Another 31 patients were added from Vanderbilt clinics who were treated for cirAEs.

The 52 patients had received either pembrolizumab, nivolumab, ipilimumab or anti-PD1 and CTLA4 combination therapy.

The types of skin reactions varied, with 15 experiencing pruritus or itchy skin, 12 experienced morbilliform eruptions or drug-induced skin rashes, 12 experienced dermatitis or inflamed and scaly rashes, eight experienced bullous pemphigoid-like eruptions (fluid-filled blisters that resemble a rare autoimmune skin disease), five experienced eczema, four experienced lichenoid (flat-topped, scaly lesions), two experienced psoriasiform (breakouts that resemble psoriasis), and one experienced acneiform or acne-like eruptions.

The median duration of cirAE from treatment cessation was 446 days. Rare cases lasted more than five years.

Other Vanderbilt authors on the study included the study’s lead author, Kylie Fletcher, BS, Rachel Goodman, MD, MBA, J. Randall Patrinely, MD, MBA, and Anna Dewan, MD, MHS.

The research received support from Medical Scholars at Vanderbilt University School of Medicine, the Susan and Luke Simons Directorship, the James C. Bradford Jr. Fund in Melanoma Cancer Research and the Van Stephenson Memorial Cancer Research Fund.

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