Support for Nurses & APPs

BECKY BARTNICKI: This is a non-accredited promotional activity. The program content was developed and approved by Janssen Biotech, Inc. and Legend Biotech.

Hello and welcome. I'm Becky Bartnicki, a Legend Biotech Cell Therapy Clinical Educator. For patients with relapsed refractory multiple myeloma receiving chimeric antigen receptor T cell or CAR-T therapy, effective shared care between a primary oncology practice and an activated treatment center, or ATC, are vital to ensure care continuity.

In this video, I will discuss the importance of shared care for CAR-T therapies broadly. I will then discuss shared care and long-term monitoring considerations specific to Carvykti and highlight the roles of nurses and advanced practice providers, APPs, in this process.

To begin, let’s talk about why shared care with CAR-T therapies is important. CAR-T therapy is an individualized treatment that is only available at ATCs. Referring a patient for CAR-T therapy expands the care team to include the ATC. Therefore, collaboration across patient care teams before, during, and after CAR-T therapy is essential for proper care coordination. Nurses and APPs play a key role in facilitating collaboration between the primary care oncology practice and the ATC.

With that context in mind, let’s discuss shared care and some long-term monitoring practices to consider when a patient is referred for and prescribed the CAR-T therapy, Carvykti. We’ll start by reviewing the indication. Indications and usage: Carvykti is a B-cell maturation antigen, BCMA-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteosome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.

Let's begin by reviewing the Carvykti treatment process and identifying opportunities for shared care. Carvykti is administered as a single infusion as part of a multistep process. The Carvykti treatment process involves collaboration between the primary oncology practice and the ATC. While execution may vary, the steps in blue may be implemented by the ATC. The steps in yellow can be a collaboration between care teams.

The process may start with a referral to the ATC from the primary oncology practice, who stays involved through the process and resumes follow-up care upon a patient’s return to their center. Before starting Carvykti, inform patients of the risk of early mortality. In a clinical study, treatment in the Carvykti arm was associated with a higher rate of death, 14%, compared to the control arm, 12%, in the first 10 months of randomization. This higher rate of death was observed before receiving Carvykti and after treatment with Carvykti. The reasons for death were progression of multiple myeloma and adverse events.

For nurses and APPs, successful Carvykti coordination means open communication, assessing team needs, and making sure potential gaps in care are addressed early. Now let’s review considerations through the process that can help enhance shared care. Let's start by considering factors that may enhance coordination of care between the ATC and primary oncology practice at the point of referral.

When preparing to refer a patient to an ATC, an ATC may be identified using the locator tool on CARVYKTIHCP.com. After sending a patient’s referral information, following up with the ATC helps ensure the referral is received. This supports information sharing. Once Carvykti eligibility is confirmed and the patient consents to treatment, care coordination for the Carvykti process may begin. Materials available on CARVYKTIHCP.com can help support these discussions and answer questions from patients and their care partners.

After T-cells are collected through leukapheresis and sent for CAR-T manufacturing, coordinated bridging therapy for disease control or reduction in baseline tumor burden may be considered for patients. Bridging therapy can be a collaboration. Coordination between the ATC and the primary oncology practice can help ensure bridging therapy is appropriate and that patients are monitored for any adverse reactions.

In the pivotal CARTITUDE-1 trial, 75% of those treated with Carvykti received bridging therapy. All Carvykti-treated patients in the pivotal CARTITUDE-4 trial received at least one bridging therapy cycle before lymphodepletion. Once the manufactured CAR-T cells are delivered to the ATC, patients complete a lymphodepleting chemotherapy regimen two to four days prior to the Carvykti infusion.

After the Carvykti infusion and before patients are returned to their primary oncology practice, patients should be monitored at least daily for seven days for signs and symptoms of cytokine release syndrome and neurologic toxicities. Instruct patients to remain within proximity of the ATC for at least two weeks following infusion.

There are important shared care considerations for coordinating the patient’s transition to follow-up care. As patients return to their primary oncology practice, the ATC should provide a post-treatment summary and monitoring plan. Clear communication between the ATC and primary oncology practice helps maintain continuity of care.

As patients return to their primary oncology practice after Carvykti infusion they should have key resources, such as the Carvykti wallet card or medical bracelet, and know where to find additional information about their treatment. Both patients and care partners also need education on recognizing and reporting to the care team signs and symptoms of potential side effects. Ongoing communication, collaboration, and care partner involvement are essential for shared care and long-term monitoring.

To facilitate long-term monitoring for Carvykti, let’s review some safety information. Carvykti has a well-studied safety profile across pivotal CARTITUDE-1 and CARTITUDE-4 trials, which included late line and early line patients respectively. This table provides the rates of important safety events that occurred during the CARTITUDE-1 and CARTITUDE-4 trials, showing median time to onset, median duration, and those adverse events that resolved along with their median time to resolution. Overall, different adverse event rates were seen across the CARTITUDE-1 and CARTITUDE-4 trials.

Importantly, long-term Carvykti care should include monitoring for potential adverse reactions. The following is a list of side effects that patient care teams should monitor after infusion of Carvykti. Educate your patients and their care partner in identifying symptoms of potential side effects.

In summary, shared care and long-term monitoring are important considerations in the Carvykti treatment journey. Nurses and APPs are key in guiding effective shared care before, during, and after Carvykti treatment.

Carvykti is a well-established option for use as early as second line in relapsed refractory multiple myeloma. Across all lines of therapy, over 10,000 patients worldwide have been treated with Carvykti.

So are you looking to strengthen your team’s understanding of CAR-T in relapsed refractory multiple myeloma? J&J and Legend Biotech nurse educators are here to support nurses and APPs across primary oncology practices and ATCs with educational resources.

Now let’s review the Carvykti Important Safety Information. Please see additional information after the Carvykti Important Safety Information.

[Important Safety Information]

BECKY BARTNICKI: To connect, simply click the Get in Touch tab to share your contact information and a member of our Nurse Educator team will reach out. Thank you for your time. We hope that this video is helpful and informative.