New results presented for Opdivo (nivolumab)
![](/46/pdcnewsitem/04/34/51/BMS.jpg)
Results demonstrate encouraging response rate in an expanded population of heavily pre-treated classical Hodgkin lymphoma patients.
Bristol-Myers Squibb (BMS) has announced new results from CheckMate -205, a multi-cohort, single-arm, Phase II trial evaluating Opdivo (nivolumab) in patients with classical Hodgkin lymphoma (cHL). These results from cohort C of the trial included patients with cHL who had received brentuximab vedotin before and/or after autologous hematopoietic stem cell transplantation (auto-HSCT). After a median follow-up of 8.8 months, the primary endpoint of objective response rate (ORR) per an independent radiologic review committee (IRRC) was 73% overall, which was consistent across patient subgroups regardless of the timing of prior brentuximab vedotin relative to auto-HSCT. The ORR was 70% in patients who received brentuximab vedotin only before auto-HSCT; 72% in patients who received brentuximab vedotin only after auto-HSCT; and 88% in patients who received brentuximab vedotin before and after auto-HSCT. The safety profile of Opdivo was consistent with previously reported data in this tumour type, and no new clinically meaningful safety signals were identified.
These data were presented at the 10th International Symposium on Hodgkin Lymphoma (ISHL) in Cologne, Germany on 25 October (Abstract #0149). This abstract was awarded the Karl Musshoff Prize for the Best Clinical Research Abstract, which is granted every 3 years in conjunction with ISHL for outstanding results in the field of Hodgkin lymphoma.
“These data from cohort C build on existing evidence supporting the benefit of Opdivo in cHL patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin,” said Andreas Engert, study investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Cologne, Germany. “Results from cohort C indicated a benefit with Opdivo regardless of the order of prior treatment with autologous hematopoietic stem cell transplantation and brentuximab vedotin, providing important insights as we continue researching the potential role Opdivo could provide for heavily pre-treated classical Hodgkin lymphoma patients.”
In May 2016, the FDA approved Opdivo for the treatment of patients with cHL who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin based on a combined analysis of data from cohort B of CheckMate -205 and the Phase I CheckMate -039 trial. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
In October 2016, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of Opdivo for the treatment of adult patients with relapsed or refractory cHL after auto-HSCT and treatment with brentuximab vedotin based on data from cohort B of CheckMate -205 and CheckMate -039. The CHMP recommendation is now being reviewed by the European Commission, which has the authority to approve medicines for the European Union. Opdivo also is currently under regulatory review for cHL in Japan.
Fouad Namouni, head of development, Oncology, BMS, commented: “We continue to expand our Immuno-Oncology science in hematology, and these latest results from CheckMate -205 will help inform our research into classical Hodgkin lymphoma and aid us in determining whether Opdivo may provide benefit to a broader population of patients living with this difficult-to-treat disease.”
Related News
-
News CPHI Podcast Series: the power of digital marketing in pharma
Digital marketing is a valuable tool for many industries, and the pharmaceutical and healthcare industry is no exception. The CPHI Podcast Series covers how marketing can be used by companies to increase their engagement and overcome challenges.&n... -
News Novel approach to creating sustainable packaging from rice husks
Researchers have created a new approach to the designing of eco-friendly nanofibres extracted from rice husks, addressing the critical need for sustainable packaging materials in food and biopharmaceutical products. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance