Gray, Kathleen

Introduction Talquetamab (Tal) is a bispecific antibody therapy approved for patients with relapsed/refractory multiple myeloma (MM), targeting both GPRC5D x CD3 receptors. Clinical studies demonstrate that Tal creates deep and durable responses, but less is known about the patient experience. This study aimed to explore the experiences of patients from the patient and physician perspectives to help understand what to expect with this first-in-class novel therapy. Methods This qualitative study consisted of two components. First, patients with documented use of Tal were identified and recruited through the HealthTree Cure Hub. Individual patients then took part in 2-hour, semi-structured virtual interviews. Patients were asked to discuss their experiences 1-2 months prior to starting Tal and 4-5 months after beginning therapy. Patients discussed GPRC5D-related symptoms (including oral, skin-related, and nail-related symptoms), overall impact, and satisfaction. Participants were US adults diagnosed with MM who took Tal for at least 4 months, either in a clinical trial or commercial setting. Interviews were conducted February-April 2024. Second, patients and physicians gathered in a facilitated roundtable discussion to review findings and generate ideas for symptom management. The roundtable lasted 2.5 hours and took place in Chicago, IL in May 2024. Results Eight men and 4 women (n=12) aged 52-79 years participated in the interviews. Interviewed participants were mostly white (84%) and college-educated (84%). Seven (58%) received Tal in a clinical trial, and 9 were still receiving Tal. Roundtable participants included 3 patients (2 male, 1 female; all white and college educated), and 3 physicians with Tal experience. In the interviews, patients reported high overall satisfaction, with most (75%) rating their satisfaction an 8 or higher on a 10-point scale. Satisfaction was largely driven by the effectiveness of therapy, with all reporting clinical improvements in their MM disease. Patients reported improvements in their energy/strength and decreased fatigue. They also reported increased physical activities and ability to work, volunteer, or engage in hobbies. Physicians affirmed these findings as consistent with their observations and noted they are also very satisfied with Tal. Oral symptoms such as distorted taste/loss of taste and dry mouth were common with varying severity. Although all interviewees (n=12) reported taste symptoms (typically starting within the first month of therapy), five said their symptoms fully improved (3 after 1 year on treatment, and 2 after stopping treatment), and 4 experienced partial recovery. Ten lost weight, but most (92%) maintained adequate nutrition. Patients and physicians suggested coping strategies including diet modifications, use of strong flavors (e.g., spices, cinnamon), monitoring weight, prioritizing adequate calories, using mouthwashes/lozenges, drinking water while eating, taking small bites, and consuming foods that are easier to swallow. They also noted that it is important to educate patients on expected symptoms before starting the treatment. Skin- and nail-related symptoms were also common but less impactful on quality of life. All patients (n=12) experienced skin- and nail-related symptoms, but most considered these symptoms mild. Skin-related symptoms such as dry skin and skin exfoliation occurred once and typically lasted 1-2 months. Nail symptoms were primarily cosmetic, and the duration varied. Suggested management strategies include skin moisturizers, nail thickeners/hardeners, keeping nails short, and wearing protective gloves. Physicians noted it's helpful to reassure patients that nail loss is not harmful. Overall, GPRC5D-related symptoms were not treatment-limiting, and no patients had to miss a dose due to these symptoms. Patients perceived these symptoms as bearable but noted the treatment was effective at controlling the disease. Conclusions This study described patient experiences and reflected how patients perceive the benefit/risk profile of talquetamab. Symptoms were perceived as bearable and high satisfaction scores were driven by strong clinical effectiveness. Patients and physicians agreed that real-world feedback from patients, practical tips, and management strategies are vitally important for patients and physicians using this novel therapy.

PURPOSE: Median duration of daratumumab (DARA) administration for treatment of multiple myeloma is 3-7 hours for the intravenous formulation (DARA IV) and 3-5 minutes for the subcutaneous formulation (DARA SC). Here, we describe clinical administration characteristics of DARA using a novel method for data extraction from electronic health records. METHODS: Time-based measurements were extracted using a scheduling/pharmacy software program that tracked patient movement through appointments for patients initiating DARA in Mayo Clinic infusion centers from April 5, 2017, to October 14, 2021. Cohorts included patients who received DARA IV or DARA SC, or converted from DARA IV to DARA SC. The DARA SC cohort was further analyzed before (DARA SC initial) and after (DARA SC shortened) a reduction in the postadministration observation time mandated by the treatment plan. Events associated with administration-related reactions (ARRs) were also identified. RESULTS: Median total clinic times were 2.7-3.0 hours shorter for DARA SC versus DARA IV. Median clinic times were highest at dose 1 and decreased with subsequent doses. Median total chair times were 2.7-2.8 hours shorter for DARA SC versus DARA IV. Incidences of ARR-related events with DARA SC were low across doses. CONCLUSION: Reduced clinic times were observed with DARA SC, indicating that use of DARA SC as a treatment option results in time savings that may free clinic resources. Furthermore, novel methods of electronic health record data extraction can provide insights that may help inform clinic resource optimization.

Abstract Introduction: Daratumumab is approved across lines of therapy for multiple myeloma (MM) by subcutaneous administration (DARA SC) or by intravenous administration (DARA IV). In clinical studies, the administration time ranges from 3-5 minutes for DARA SC versus 3-7 hours for DARA IV, and DARA SC is associated with reduced rates of administration-related reactions (ARRs). These characteristics of DARA SC are associated with benefits for clinics in terms of safety and clinic time. We previously reported DARA administration characteristics at Mayo Clinic infusion centers: DARA SC had shorter total clinic and total chair times compared with DARA IV, and DARA SC was associated with very low rates of ARR-related events (Soefje S, et al. EHA Library. 2021). Based upon this analysis, the treatment plan was modified to reduce the mandated observation time for DARA SC to improve clinic efficiency. Here, we describe updated clinical administration characteristics for DARA SC at Mayo Clinic infusion centers before and after the reduction in procedure-mandated observation time, versus DARA IV, using a novel empirical data extraction approach from Electronic Health Records (EHR). Methods: Patients ≥18 years of age with an ICD-9/10 diagnosis code of MM and a first DARA treatment between April 5, 2017 and June 22, 2021 were identified in Mayo Clinic's EHR database. Data were extracted using a scheduling and pharmacy software that tracked patient movement through appointments at a Mayo Clinic infusion center. On May 3, 2021, the Mayo treatment plan was amended to shorten the mandated post-administration observation time for DARA SC from 4 to 2 hours for Dose 1 and from 1 hour to 30 minutes for Doses 2 and 3, with no mandated observation time for Doses 4+. In this analysis, data were captured for patients initiating DARA IV throughout the defined treatment window. For DARA SC, data were captured for patients starting DARA SC therapy on the initial treatment plan (before May 3, 2021; DARA SC initial) and after the change to shorten the mandated post-administration observation time for DARA SC (after May 3, 2021; DARA SC shortened). Time-based measures included: total clinic time (check-in time through patient check-out); total chair time (time from infusion room entry to infusion room exit or check-out time, including order review, pharmacy preparation time, and post-administration observation time); and observation time (time from the end of medication administration to infusion room exit or patient check-out). The medication administration time documented for DARA SC was 0 minutes due to the default duration for SC injections in the EHR. Results: In total, 755 (DARA IV, n=586; DARA SC initial, n=145; DARA SC shortened, n=24) patients received DARA treatment for MM. For all doses combined, the median total clinic time was 2.9 hours shorter for DARA SC compared with DARA IV (DARA IV, 4.9 hrs; DARA SC initial, 2.0 hrs). The median total clinic time for DARA SC and DARA IV was highest at Dose 1 (DARA IV, 9.5 hrs; DARA SC initial, 6.1 hrs; DARA SC shortened, 4.4 hrs) and lower for subsequent doses (Dose 4+: DARA IV, 4.6 hrs; DARA SC initial, 1.7 hrs; DARA SC shortened, 1.6 hrs; Figure). Similarly, the median total chair time was 2.7 hours shorter in the DARA SC group compared with the DARA IV group for all doses combined (DARA IV, 4.1 hrs; DARA SC initial, 1.4 hrs). The median total chair time for DARA SC and DARA IV was highest at Dose 1 (DARA IV, 8.8 hrs; DARA SC initial, 5.6 hrs; DARA SC shortened, 3.9) and lower for subsequent doses (Dose 4+: DARA IV, 3.7 hrs; DARA SC initial, 1.1 hrs; DARA SC shortened, 1.1 hrs). Conclusion: Marked reductions in the amount of time spent both in clinic and in chair were observed with DARA SC compared with DARA IV, with additional time savings observed following the Mayo procedure change to reduce the DARA SC mandated observation time. These favorable DARA SC administration characteristics may indicate a reduction in the burden on both clinical resources and patients in Mayo Clinic infusion centers. These results add to the growing body of evidence supporting the use of DARA SC as an efficient and convenient treatment administration option for patients with MM. Figure 1 Figure 1. Disclosures Soefje: Beigene: Consultancy; Pfizer: Speakers Bureau; Janssen: Consultancy, Research Funding. Carpenter: nference Inc.: Current Employment; Janssen: Consultancy. Carlson: nference Inc.: Current Employment; Janssen: Consultancy. Awasthi: nference Inc.: Current Employment, Current holder of individual stocks in a privately-held company; Janssen: Consultancy. Lin: Janssen: Current Employment. Kaila: Janssen Scientific Affairs, LLC: Current Employment. Kayal: nference Inc.: Current Employment; Janssen: Consultancy. Kirkup: nference Inc.: Current holder of individual stocks in a privately-held company, Ended employment in the past 24 months; Path AI: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Wagner: nference Inc.: Current Employment; Janssen: Consultancy. Gray: Janssen Scientific Affairs, LLC: Current Employment, Current holder of individual stocks in a privately-held company. Kumar: Oncopeptides: Consultancy; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Carsgen: Research Funding; Antengene: Consultancy, Honoraria; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; KITE: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Research Funding; Astra-Zeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding; Bluebird Bio: Consultancy; Beigene: Consultancy; Tenebio: Research Funding; Roche-Genentech: Consultancy, Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive: Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Research Funding.