All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the International Myeloma Foundation or HealthTree for Multiple Myeloma.
The mm Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the mm Hub cannot guarantee the accuracy of translated content. The mm and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Multiple Myeloma Hub is an independent medical education platform, sponsored by Bristol Myers Squibb, GSK, Johnson & Johnson, Pfizer, Roche and Sanofi. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View multiple myeloma content recommended for you
Phase III IRAKLIA trial: On-body injector SC vs IV isatuximab with Pd for RRMM
The administration of subcutaneous (SC) isatuximab (Isa) utilizing a novel on-body injector (OBI) offers potential benefits compared with intravenous (IV) infusions and manual injections, such as shorter injection duration, smaller administration volume, and hands-free administration. IRAKLIA is the first global, noninferiority, phase III trial (NCT05405166) evaluating the efficacy and safety of Isa OBI + pomalidomide and dexamethasone (Pd) vs Isa IV + Pd in patients with relapsed/refractory multiple myeloma (RRMM). Results from the study were published by Ailawadhi et al. in the Journal of Oncology. Patients in the Isa OBI arm (n = 263) received Isa 1400 mg SC via OBI, and the Isa IV arm (n = 268) received Isa 10 mg/kg IV over 4-weekly cycles. All patients received oral pomalidomide 4 mg and dexamethasone 40 mg. The coprimary endpoints were overall response rate and steady-state Isa trough concentration (Ctrough). Key secondary endpoints included very good partial response or better rate, Ctrough at 4 weeks, the incidence rate of injection reaction, and responses to the patient experience and satisfaction questionnaire. The median follow-up duration was 12 months.
|
Key learnings |
The ORR was 71.1% in the Isa OBI arm and 70.5% in the Isa IV arm (RR, 1.008; 95% CI, 0.903–1.126), while the ≥VGPR rates were 46.4% vs 45.9%, respectively. |
The mean (SD) Ctrough was 499 (259) µg/mL in the Isa OBI arm and 341 (169) µg/mL in the Isa IV arm (GMR, 1.532), while the mean (SD) CT4W was 421.5 (214.9) µg/mL and 301.9 (117.1) µg/mL (GMR, 1.302). |
In the Isa OBI vs Isa IV arms, IRs occurred in 1.5% and 25% (p < 0.0001), Grade 3 IRs in 0.4% and 1.1%, and IRs leading to treatment discontinuation in 0% and 0.8% of patients, respectively. |
The Isa OBI arm showed a higher PESQ response at C5D15 compared with the Isa IV arm (70.0% vs 53.4%; OR, 2.036; 95% CI, 1.425–2.908; p = 0.0001). |
Isa OBI showed comparable efficacy and safety compared with Isa IV in patients with RRMM with a low IR rate, supporting its viability as a novel method for administering SoC combinations. OBI may potentially enable administration of anti-CD38 treatment at home by both HCPs and patients. |
CI, confidence interval; C5D15, Cycle 5, Day 15; CT4W, Ctrough at 4 weeks; GMR, geometric mean ratio; HCP, healthcare professional; IR, infection reaction; Isa, isatuximab; IV, intravenous; OBI, on-body injector; OR, odds ratio; ORR, overall response rate; Pd, pomalidomide and dexamethasone; PESQ, patient experience and satisfaction questionnaire; RR, relative risk; RRMM, relapsed/refractory multiple myeloma; SC, subcutaneous; SD, standard deviation; SoC, standard of care; VGPR, very good partial response.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
Your opinion matters
HCPs, which of the following best characterizes your perception of belantamab mafodotin in combination (BVd, BPd) for the treatment of relapsed/refractory multiple myeloma?
