Comparative Efficacy of Daratumumab Monotherapy and Pomalidomide Plus Low-Dose Dexamethasone in the Treatment of Multiple Myeloma: A Matching Adjusted Indirect Comparison

Sanden, Suzy Van; Ito, Tetsuro; Diels, Joris; Vogel, Martin; Belch, Andrew R.; Oriol, Albert

doi:10.1634/theoncologist.2017-0103

Cited by 10 publications

(15 citation statements)

References 34 publications

(67 reference statements)

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“…MAIC analyses have been conducted for biologics across a variety of therapeutic areas, including haemophilia [ 18 ], psoriasis [ 19 ] and multiple myeloma [ 20 ]. The objective of this study was to perform a MAIC of benralizumab versus IL-5-directed monoclonal antibodies for the treatment of patients with severe, uncontrolled asthma and with an eosinophilic phenotype.…”

Section: Introductionmentioning

confidence: 99%

Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review

et al. 2018

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Benralizumab is an interleukin-5 receptor α-directed cytolytic monoclonal antibody that directly depletes eosinophils. Its relative efficacy versus other IL-5-targeted treatments for patients with severe, uncontrolled asthma is not yet fully characterised.We performed a matching-adjusted indirect comparison (MAIC) of benralizumab versus mepolizumab and reslizumab. Trials were selected through systematic review and evaluation of trial methods. Benralizumab patient-level data were weighted to match treatment-effect-modifying patient characteristics of comparator trials before indirect efficacy comparisons.After matching adjustment, benralizumab and mepolizumab reduced exacerbations versus placebo by 52% and 49%, respectively (rate ratio [RR] 0.94, 95% CI 0.78–1.13; n=1524) and reduced the rate of exacerbations requiring hospitalisation/emergency department visit by 52% and 52%, respectively (RR 1.00, 95% CI 0.57–1.75; n=1524). Benralizumab and mepolizumab similarly improved pre-bronchodilator forced expiratory volume in 1 s at 32 weeks (difference 0.03 L, 95% CI −0.06–0.12; n=1443). Benralizumab and reslizumab patient populations were too dissimilar to generate a sufficient effective sample size to produce a reliable estimate for MAIC.MAIC is a robust way to indirectly compare treatment efficacies from trials with heterogeneous patient populations. When baseline patient characteristics were matched across asthma trials, benralizumab and mepolizumab yielded similar efficacy.

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Section: Introductionmentioning

confidence: 99%

Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review

et al. 2018

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“…Also, indirect treatment comparison studies of daratumumab monotherapy (pooled from the GEN501 and SIRIUS studies) and comparator therapies (different retrospective cohort studies) have indicated a consistent OS benefit for daratumumab monotherapy. 4,[19][20][21][22][23][24] Adjusted comparisons of patient-level data pooled from daratumumab monotherapy clinical studies (patients treated with 16 mg/kg in the SIRIUS/GEN501 studies) with standard care realworld data from the Czech Republic, 21 United States, 22 International Myeloma Foundation, 23 and International Myeloma Working Group 24 historical control cohorts of patients with RRMM revealed improved OS for daratumumab compared with the realworld historical control data (adjusted hazard ratio for OS, 0.35, 0.30, 0.41, and 0.44, respectively) in heavily pretreated patients with RRMM. Data from the Czech registry revealed that the control cohort differed in median age (64 vs. 62 years), median number of previous therapy lines (5 vs. 4), previous exposure to carfilzomib (41.2% vs. 0.3%) and pomalidomide (55.4% vs. 0.6%), triple or more refractory status (64.2% vs. 5.3%), and OS (11.9 vs. 20.1 months) from daratumumab trial patients.…”

Section: Discussionmentioning

confidence: 99%

Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

Beksaç

Aydın

Göker

et al. 2020

Clinical Lymphoma Myeloma and Leukemia

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The present study investigated the efficacy and safety profile of daratumumab monotherapy in 42 patients with relapsed refractory multiple myeloma through a Turkish early access program. The current findings have confirmed the efficacy of daratumumab monotherapy in heavily pretreated patients with refractory multiple myeloma because of the deep and durable responses and favorable safety and tolerability profile. Background: In countries where frontline drug approval is limited to first-generation proteasome inhibitors or immunomodulatory drugs, relapses have been both more frequent and less durable. We investigated real world data on the efficacy and safety of daratumumab monotherapy among patients with relapsed refractory multiple myeloma (RRMM) from Turkey using a prospective early access program. Patients and Methods: A total of 42 patients with RRMM after a minimum of 3 previous lines of proteasome inhibitor/immunomodulatory drug-based treatments were included from 25 centers across Turkey. Daratumumab monotherapy was administered intravenously at a dose of 16 mg/kg weekly (cycles 1-2), on alternate weeks (cycles 3-6), and monthly thereafter. Results: The median daratumumab monotherapy duration was 5.5 months (range, 0.2-28.7 months). The overall response rate was 45.2%, including 14 (33.3%) partial responses, 4 (9.5%) very good partial responses, and 1 (2.4%) complete response. The

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“…The MAIC methodology has been applied extensively in oncology to assess the effects of treatments for various tumor types. 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 …”

Section: Introductionmentioning

confidence: 99%

A matching-adjusted indirect comparison of combination nivolumab plus ipilimumab with BRAF plus MEK inhibitors for the treatment of BRAF-mutant advanced melanoma☆

Tarhini

Toor²,

Chan³

et al. 2021

ESMO Open

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Background Approved first-line treatments for patients with BRAF V600–mutant advanced melanoma include nivolumab (a programmed cell death protein 1 inhibitor) plus ipilimumab (a cytotoxic T lymphocyte antigen-4 inhibitor; NIVO+IPI) and the BRAF/MEK inhibitors dabrafenib plus trametinib (DAB+TRAM), encorafenib plus binimetinib (ENCO+BINI), and vemurafenib plus cobimetinib (VEM+COBI). Results from prospective randomized clinical trials (RCTs) comparing these treatments have not yet been reported. This analysis evaluated the relative efficacy and safety of NIVO+IPI versus DAB+TRAM, ENCO+BINI, and VEM+COBI in patients with BRAF -mutant advanced melanoma using a matching-adjusted indirect comparison (MAIC). Patients and methods A systematic literature review identified RCTs for DAB+TRAM, ENCO+BINI, and VEM+COBI in patients with BRAF -mutant advanced melanoma. Individual patient-level data for NIVO+IPI were derived from the phase III CheckMate 067 trial ( BRAF -mutant cohort) and restricted to match the inclusion/exclusion criteria of the comparator trials. Treatment effects for overall survival (OS) and progression-free survival (PFS) were estimated using Cox proportional hazards and time-varying hazard ratio (HR) models. Safety outcomes (grade 3 or 4 treatment-related adverse events) with NIVO+IPI and the comparators were compared. Results In the Cox proportional hazards analysis, NIVO+IPI showed improved OS compared with DAB+TRAM (HR = 0.53; 95% confidence interval [CI], 0.39-0.73), ENCO+BINI (HR = 0.60; CI, 0.42-0.85), and VEM+COBI (HR = 0.50; CI, 0.36-0.70) for the overall study period. In the time-varying analysis, NIVO+IPI was associated with significant improvements in OS and PFS compared with the BRAF/MEK inhibitors 12 months after treatment initiation. There were no significant differences between NIVO+IPI and BRAF/MEK inhibitor treatment from 0 to 12 months. Safety outcomes favored DAB+TRAM over NIVO+IPI, whereas NIVO+IPI was comparable to VEM+COBI. Conclusion Results of this MAIC demonstrated durable OS and PFS benefits for patients with BRAF -mutant advanced melanoma treated with NIVO+IPI compared with BRAF/MEK inhibitors, with the greatest benefits noted after 12 months.

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Comparative Efficacy of Daratumumab Monotherapy and Pomalidomide Plus Low-Dose Dexamethasone in the Treatment of Multiple Myeloma: A Matching Adjusted Indirect Comparison

Cited by 10 publications

References 34 publications

Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review

Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review

Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

A matching-adjusted indirect comparison of combination nivolumab plus ipilimumab with BRAF plus MEK inhibitors for the treatment of BRAF-mutant advanced melanoma☆

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