Session: 907. Outcomes Research: Plasma Cell Disorders: Poster II
Hematology Disease Topics & Pathways:
Combination therapy, Research, Clinical Practice (Health Services and Quality), Elderly, Plasma Cell Disorders, Health outcomes research, Clinical Research, Diseases, Patient-reported outcomes, Treatment Considerations, Biological therapies, Real-world evidence, Lymphoid Malignancies, Monoclonal Antibody Therapy, Study Population, Human, Transplantation (Allogeneic and Autologous)
Methods: A retrospective, multi-center, chart review study was conducted at 9 clinical sites in the US. All eligible adults (except at one site, where eligible pts were randomly selected) with TE NDMM initiating FL DVRd therapy between January 1, 2019, and June 30, 2022, were included (index date = date of initiation). Pts were excluded if they previously received any treatment for MM for ≥30 days, previously participated in a clinical trial related to MM, were treated for any other invasive malignancy within 12 months prior to FL DVRd initiation or had amyloidosis at the index date. Demographic and clinical characteristics were evaluated up to 12 months pre-index and pts were followed until death or the last record of clinical activity. This abstract presents results from an interim analysis.
Results: A total of 180 pts initiating FL DVRd were included (median [interquartile range] age: 63 [12.5] years, age ≥65 years: 46.1%; male: 58.3%; White: 67.8%; Black: 11.7%), with a median follow-up of 26.4 months. Of 158 pts with a reported Eastern Cooperative Oncology Group (ECOG) score, 43.0% had a score of 0. Moreover, 86 pts had a reported R-ISS stage (I: 32.6%, II: 41.9%, III: 25.6%). Out of 151 pts with available data, 39 (25.8%) had high-risk cytogenetic abnormalities (HRC), including del[17p], t[14;16], or t[4;14]. Baseline demographics and disease characteristics are in line with the pts treated with DVRd in the PERSEUS (median age: 61.0 years; male: 59.4%; White: 93.0%; ECOG 0: 62.3%, HRC: 21.4%) and GRIFFIN (median age: 59.0 years; male: 55.8%; White: 82.0%; Black: 13% ECOG 0: 38.6%, HRC: 16%) trials. During follow-up, the median duration of the DVRd induction phase was 6.1 months and 128 (71.1%) pts received an autologous stem cell transplantation (SCT). Of the 51 pts without SCT, 37 (72.5%) deferred transplant, among which 21 (56.8%) of the deferrals went directly to maintenance therapy, with 14 (66.7%) using >1 agent in maintenance. In the overall population, 17 (9.4%) pts received consolidation therapy and 155 (86.1%) pts received maintenance therapy, including 64 (41.2%) with R monotherapy, 60 (38.7%) with DR, 12 with VR, 7 with DV, 6 with DVR, 4 with V monotherapy, and 2 with D monotherapy.
The cohort treated with DVRd induction followed by DR maintenance (DVRd-DR) was slightly older (median: 65 years), had more males (63.3%), and a lower proportion of Black pts (6.7%) than the cohort with DVRd induction followed by R maintenance (DVRd-R; median age: 62 years, males: 56.3%, and Black: 14.1%). More pts in the DVRd-R cohort received a SCT (79.7% vs. 68.3%) than those in the DVRd-DR cohort. Compared to the DVRd-DR cohort, more pts with DVRd-R had ECOG score of ≥1 (63.9% vs. 45.0%). In contrast, the DVRd-DR cohort had more pts with HRC (17.0%) compared to DVRd-R (13.0%). For the DVRd-R and DVRd-DR group, the median duration of the induction phase was 6.4 and 6.1 months, respectively, and median duration of active maintenance was 16.5 and 14.3 months, respectively.
Conclusion: Compared to pts in the PERSEUS trial, the TE NDMM pts treated with FL DVRd identified in this real-world chart review study were observed to be older, and with a more diverse racial profile comparable to the US-only GRIFFIN trial population. In the real-world, use of consolidation therapy was less common and DVRd-DR maintenance was used more often in pts aged ≥65 years and in those with higher cytogenetic risk. Also, fewer pts with DVRd-DR than DVRd-R received a SCT. Data on outcomes will be presented at the conference, with additional pts expected.
Disclosures: Tan: Takeda: Research Funding; Sanofi: Honoraria; Janssen: Honoraria, Research Funding. Gordan: GENZYME CORPORATION: Consultancy; Evolution Medical Communications, LLC: Consultancy; HMP Omnimedia LLC: Consultancy; Illumina Inc: Consultancy; Integra PrecisionQ LLC: Consultancy; INTERNATIONAL ONCOLOGY NETWORK SOLUTIONS INC: Consultancy; IQVIA INC.: Consultancy; MJH Life Sciences, LLC: Consultancy; NATIONAL COMMUNITY ONCOLOGY DISPENSING ASSOCIATION INC.: Consultancy; Precision Value and Health, Inc: Consultancy; Celgene Corporation: Consultancy; CELLECTAR BIOSCIENCES, INC.: Consultancy. Larson: Ionis: Other: Clinical trial; Sanofi: Other: Clinical trial; Regeneron: Other: Clinical trial; BMS: Other: Clinical trial; Pfizer: Other: Clinical trial; Bioline: Other: Clinical trial; Allogene: Other: Clinical trial; Janssen: Research Funding; Immpact bio: Other: Clinical trial; TORL Biotherapeutics: Current holder of stock options in a privately-held company. Davies: Regeneron: Other; Janssen: Other; GSK: Other; Bristol Myers Squibb: Other; AbbVie: Other; Takeda: Other; Sanofi: Other. Oveisi: Janssen: Consultancy, Research Funding; Pfizer: Honoraria. Gupta-Werner: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Medhekar: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Cortoos: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Armoon: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Rahman: Disc Medicine: Research Funding; AstraZeneca: Research Funding; Janssen Scientific Affairs: Research Funding; Pfizer: Research Funding. Vanden Eynde: Janssen Scientific Affairs: Research Funding; Xenon: Research Funding. Lafeuille: Pfizer: Research Funding; Janssen Scientific Affairs: Research Funding; AbbVie: Research Funding; Xenon: Research Funding; Pharmacyclics LLC, an AbbVie Company: Research Funding. Reitan: Janssen: Research Funding. Milkovitch: Janssen: Research Funding. Sborov: Society of Utah Medical Oncology: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Consultancy; Legend Biotech: Consultancy; Bioline: Consultancy; Genentech, Inc.: Consultancy; Abbvie: Consultancy; Arcellx: Consultancy; AstraZeneca: Consultancy; Pfizer: Consultancy, Research Funding; Janssen: Consultancy; Binaytara Foundation: Honoraria; Parexel, Keosys: Other: IRC; University of Utah, Huntsman Cancer Institute: Current Employment; GlaxoSmithKline: Consultancy; Sanofi: Consultancy. Kaila: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Usmani: Abbvie: Consultancy, Research Funding; Bristol-Myers Squibb - Celgene:: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Array Biopharma: Research Funding; Sanofi: Consultancy, Research Funding; Gracell: Consultancy; EdoPharma: Consultancy; SkylineDX: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; SeaGen: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Gilead: Research Funding; SecuraBio: Consultancy; Genentech: Consultancy; Pfizer: Consultancy; Pharmacyclics: Research Funding; TeneoBio: Consultancy; GSK: Consultancy, Research Funding; Sanofi: Consultancy, Research Funding; Oncopeptides: Consultancy; Merck: Research Funding; Bristol-Myers Squibb - Celgene: Consultancy, Research Funding; Johnson & Johnson - Janssen: Consultancy, Research Funding.
See more of: Oral and Poster Abstracts