Advancing Cancer Care with Bispecific Antibodies in the Community Setting: Insights from Dr. Ralph Boccia and Lisa Raff, PharmD
By ION
In the evolving landscape of oncology, bispecific antibodies have emerged as a promising innovation, offering new therapeutic avenues for challenging cancer types. Two experts in this field, Ralph Boccia, MD and Lisa Raff, PharmD, have shared their experiences and insights on integrating bispecifics into clinical practice, highlighting both the challenges and the transformative potential of these therapies.
Dr. Ralph Boccia: Pioneering Bispecifics in Community Oncology
Dr. Ralph Boccia, Medical Director of the Center for Cancer and Blood Disorders in Bethesda, Maryland, has been instrumental in advancing the use of bispecific antibodies in the community setting. His practice was among the first in the United States to open the clinical trial of epcoritamab in relapsed lymphoma, and he personally enrolled the first two patients, marking a significant milestone in the clinical application of bispecifics.
Dr. Boccia emphasizes the importance of developing and adhering to standardized operating procedures (SOPs) as a cornerstone for successful implementation. "We developed the SOPs first at the research level and then through AON [American Oncology Network] with our guidance," he explains. This framework ensures that healthcare providers are well-equipped to manage the unique toxicities and side effects associated with some bispecifics, such as cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS).
Despite the promising results observed in clinical trials, Dr. Boccia acknowledges the challenges that come with introducing new therapies to community practices. "There's a learning curve here," he says, adding that as the medical community becomes more comfortable with these therapies, their adoption in community-based practices will expand. He also highlights the need for a shift from hospital-based to outpatient treatments, a transition that his practice actively pursues.
Dr. Boccia's approach to managing side effects is proactive and patient-centered. "We're very much focused on prevention," he states, detailing how his team ensures patients have dexamethasone on hand at home so potential side effects can be managed swiftly, thus minimizing the need for emergency department visits. He notes that such strategies not only improve patient outcomes but also facilitate greater access to treatments in community settings, which historically may have been hesitant to adopt new technologies due to safety concerns.
Dr. Boccia also highlights the role of pharmaceutical companies in supporting educational efforts, noting that such partnerships are crucial in fostering an environment where patients receive timely and effective care, particularly in community settings where resources may be limited.
Lisa Raff: A Collaborative Framework for Bispecific Integration
Lisa Raff, PharmD, Vice President of Pharmacy Services at One Oncology, offers a comprehensive perspective on the integration of bispecific antibodies across a network of community oncology practices. Her role involves evaluating both clinical and operational aspects of bispecifics, ensuring that these therapies can be effectively implemented within diverse practice settings.
Raff describes the adoption of bispecifics as a collaborative effort, requiring strong partnerships with hospitals and a multidisciplinary approach within practices. "You need a good hospital partnership," she insists, emphasizing the importance of having an educated and engaged hospital partner to manage potential complications like CRS. A collaborative, multidisciplinary team – involving clinicians, administrative staff, and the financial team – is essential to drive these initiatives forward.
Raff noted that OneOncology practices have adopted three operating models for administering bispecifics based on the capabilities/preferences of the individual sites. “We start with looking at when the drug is approved, what premedications we need to give. Is there REMS [Risk Evaluation and Mitigation Strategy] required? Is hospitalization suggested?” to determine the best operating model for each bispecific.
• A Complete Outpatient Model in which patients receive all treatments and monitoring within the community practice, without any hospital admission for observation.
• An In-Patient Model where the patients are either fully admitted for step-up dosing and observation or admitted for initial therapy and return to the practice for maintenance.
• A Hybrid Model where bispecifics are administered in the community oncology clinic and the patient is admitted to the hospital for observation only.
OneOncology has developed a detailed playbook to support member practices in launching bispecific programs. "We do have a 50-page playbook," Raff explains, “which goes over things such as CRS and ICANS management, prophylactic medications that are required prior to bispecific administration, and the type of monitoring required.” The playbook also includes detailed guidelines on patient communication and emergency procedures. It specifies the frequency of calls to patients, the conditions under which patients should contact the clinic, the criteria for sending a patient to the emergency room versus coming into the clinic, and ensuring patients have appropriate treatments on hand for early intervention.
Overcoming Barriers and Looking Forward
Both Dr. Boccia and Raff acknowledge the barriers to widespread adoption of bispecifics, including the need for specialized training, managing financial costs, and overcoming regulatory hurdles. However, they remain optimistic about the future of these therapies. "This process is going to work and is effective," asserts Dr. Boccia, while Raff envisions a collaborative landscape where hospitals, community oncologists, and manufacturers work together to prioritize patient care.
