Matching-adjusted indirect treatment comparison (MAIC) of teclistamab (tec) versus belantamab mafodotin (belamaf) for the treatment of patients (pts) with triple-class exposed (TCE), relapsed/refractory multiple myeloma (RRMM).

Authors

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Philippe Moreau

Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France

Philippe Moreau , Saad Zafar Usmani , Niels W.C.J. van de Donk , Alfred L. Garfall , Michel Delforge , Albert Oriol Rocafiguera , Ajay K. Nooka , Laura Rosiñol , Nizar J. Bahlis , Paula Rodríguez-Otero , Thomas G. Martin , Joris Diels , Suzy Van Sanden , Lixia Pei , Eric Ammann , Rachel Kobos , Mary Slavcev , Jennifer Smit , Anil Londhe , Amrita Y. Krishnan

Organizations

Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France, Memorial Sloan Kettering Cancer Center, New York, NY, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, University of Leuven, Leuven, Belgium, Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain, Emory University, Winship Cancer Institute, Atlanta, GA, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain, Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada, Clínica Universidad de Navarra, Madrid, Spain, University of California-San Francisco, San Francisco, CA, Janssen Pharmaceutica NV, Beerse, NJ, Belgium, Janssen Pharmaceutica NV, Beerse, Belgium, Janssen Research & Development, Raritan, NJ, Janssen Global Services, Raritan, NJ, Janssen Research & Development, Spring House, PA, Janssen Research & Development, Titusville, NJ, City of Hope Comprehensive Cancer Center, Duarte, CA

Research Funding

Pharmaceutical/Biotech Company

Background: Pts with RRMM who are TCE to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 antibodies have limited treatment options. While there is no standard of care for treatment of pts with TCE RRMM, belamaf is a recently approved, novel therapeutic option. MajesTEC-1 (NCT04557098) is a single-arm phase 1/2 study evaluating tec, a B-cell maturation antigen × CD3 bispecific antibody in pts with TCE RRMM who received ≥3 prior lines of therapy (LOT). Given the absence of a control arm in MajesTEC-1, we compared efficacy outcomes of pts who received tec at the recommended phase 2 dose in MajesTEC-1 with those of pts treated with belamaf in the phase 2 DREAMM-2 trial (NCT03525678). Methods: An unanchored MAIC was performed using individual pt-level data (IPD) from MajesTEC-1 (tec 1.5 mg/kg weekly; N = 150) at a clinical cutoff of Sep 7, 2021, and published summary-level data from pts who received the approved dose of belamaf in DREAMM-2 (2.5 mg/kg every 3 weeks; N = 97). The DREAMM-2 eligibility criteria were applied to pts from the intent-to-treat population of MajesTEC-1. IPD from MajesTEC-1 were weighted to match the aggregated DREAMM-2 baseline pt characteristics. Baseline characteristics of prognostic significance (refractory status, cytogenetic profile, International Staging System stage, presence of extramedullary disease, and number of prior LOT) were adjusted for in the analysis. Comparative efficacy of tec vs belamaf was estimated for overall response rate (ORR), complete response or better (≥CR) rate, progression-free survival (PFS), overall survival (OS), and duration of response (DOR). For binary endpoints (ORR and ≥CR rate), the relative effects of tec vs belamaf were quantified using an odds ratio (OR) and 95% CI derived from a weighted logistic regression analysis, while time-to-event endpoints (DOR, PFS, OS) were estimated using a weighted Cox proportional hazards model. Results: After adjustment, the effective sample size (ESS) of the MajesTEC-1 cohort was 33 and baseline characteristics for the reweighted MajesTEC-1 population were balanced with the DREAMM-2 population. Pts treated with tec had an improved ORR (OR 2.05; 95% CI 0.92–4.57; P= 0.0786), ≥CR rate (OR 2.13; 95% CI 0.80–5.65; P= 0.1283), PFS (HR 0.63; 95% CI 0.34–1.15; P= 0.1338), OS (HR 0.95; 95% CI 0.47–1.92; P= 0.8897), and DOR (hazard ratio [HR] 0.19; 95% CI 0.05–0.73; P= 0.0149) compared with belamaf. The reduced ESS following adjustment may account for the lack of statistical significance for most outcomes. Conclusions: These analyses demonstrated statistically improved DOR for tec vs belamaf and numerically favorable results for other outcomes, highlighting its potential as a treatment for pts with TCE RRMM who received ≥3 prior LOT.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Plasma Cell Dyscrasia

Track

Hematologic Malignancies

Sub Track

Multiple Myeloma

Clinical Trial Registration Number

NCT04557098; NCT03525678

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 8035)

DOI

10.1200/JCO.2022.40.16_suppl.8035

Abstract #

8035

Poster Bd #

459

Abstract Disclosures