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 Lymphoma Coalition.
The lym 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 lym Hub cannot guarantee the accuracy of translated content. The lym 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.
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 lymphoma & CLL content recommended for you
Inotuzumab ozogamicin plus rituximab therapy is not superior to other comparators for relapsed refractory B-cell Non-Hodgkin Lymphoma
On 5th July 2017, Dr Nam Dang, from the University of Florida Health, et al. published study results in a Letter to the Editor of the British Journal of Haematology for a randomized, phase III, open-label study of inotuzumab ozogamicin plus rituximab (R-InO) treatment for patients with Relapsed/Refractory (R/R) aggressive B-cell Non-Hodgkin Lymphoma (B-NHL) (NCT01232556).1
The study compared the efficacy and safety of R-InO with either rituximab plus bendamustine (R-B) or rituximab plus gemcitabine (R-G) in adults with R/R CD20+/CD22+ B-NHL who were not candidates for chemotherapy.
Patients were enrolled to the study (n=338) between February 2011 and May 2013 and randomized to receive R-InO (n=166) or investigator’s choice (IC) of either R-B (n=137) or R-G (n=35). The primary endpoint was Overall Survival (OS). Secondary endpoints were Progression-Free Survival (PFS) and Objective Response Rate (ORR).
Two interim analyses (IA) were planned at 40% and 70% of OS events. Since the IA 40% estimated HR > 0.9 for OS in R-InO vs IC, the study was terminated on 16th May 2013.
Key findings:
- Median follow-up: R-InO; 14.9 (0.4–8) months and IC; 15.9 (0.1–31.2) months
- Median OS: R-InO vs IC was 9.5 (7.0–14.5) and 9.5 (7.7–14.1) months and not statistically significant: (P = 0.708; HR [95% Confidence Interval (CI)] = 1.1 [0.8–1.4])
- Median PFS: R-InO vs IC was 3.7 (2.9–5.0) and 3.5 (2.8–4.9) months and not statistically significant: (P = 0.27; HR [95% CI] = 0.9 [0.7–1.2])
- ORR: 41% (95% CI, 33–49%) for R-InO and 44% (36–51%) for IC (arm difference, 3% [–8–13%]; P = 0.714
The study did not show treatment superiority for R-InO compared with IC in terms of OS. The authors noted that there are limited treatment options for patients with R/R aggressive B-NHL who are not candidates for high-dose chemotherapy, therefore, the efficacy shown for R-InO means that it remains a viable treatment option.
References