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

Abstract

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

Daratumumab monotherapy for relapsed/refractory multiple myeloma, focussed on clinical trial‐unfit patients and subsequent therapy

“…We believe that the trial‐unfit group significantly contributed to the poor PFS1 and had more cases that required the interruption of DM due to fatal infections. Comparing our present data and other real‐world DM data, using a relatively small and single‐centre patient series, 19–22 our present data included higher proportions of patients who had discontinuation of treatment due to severe AEs. The inclusion of these patients seemed to underlie the relatively poor survival outcomes, despite a higher ORR of 42·1%.…”

Treatment patterns and effectiveness of patients with multiple myeloma initiating Daratumumab across different lines of therapy: a real-world chart review study

“…This study reports the treatment patterns of patients initiating daratumumab across several lines of treatment in the real-world in the United States, including in first line and including daratumumab re-treatment. Most other real-world studies have focused on heavily pretreated patients [ 5 , 17 – 20 ] or had relatively small sample sizes [ 21 , 22 ].…”

Relaps refrakter multiple myelomda daratumumabın tekli ve kombine tedavi sonuçları-tek merkez deneyimi

“…[8] Pollux çalışmasında ise lenalidomide and dexamethasone kombinasyonuna dara eklendiğinde (dara-len-dex) 12 aylık progresyonsuz sağkalımın %60.1'den %83.2'e, genel sağkalımın ise %76.4 den %92.9 kadar çıktığı görülmüştür. [9] Türkiye'de daratumumab ile ilgili gerçek yaşam verilerini içeren literatür sayısı erken erişim programından elde edilen 42 hastalık bir monoterapi çalışması dışında oldukça kısıtlıdır [10] Bu nedenle biz de bu çalışmada merkezimizde hem monoterapi olarak, hem de kombinasyon ile daratumumab alan hastaların yanıtlarını ve sağkalımlarını değerlendirdik.…”