View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
In association with Cytiva for Cell & Gene Therapy coverage
  1. News
August 24, 2021

Novartis’ Kymriah fails to meet primary goal in non-Hodgkin lymphoma trial

The safety profile of the drug in the Phase III BELINDA trial was in line with the already reported data. 

Novartis has reported that Kymriah (tisagenlecleucel) failed to meet the primary goal of the Phase III BELINDA clinical trial in aggressive B-cell non-Hodgkin lymphoma (NHL) patients who relapsed or did not respond to first-line therapy.

Kymriah is a cluster of differentiation 19 (CD-19)-targeting genetically altered autologous T-cell immunotherapy.

Developed in partnership with the Perelman School of Medicine at the University of Pennsylvania, Kymriah is the first CAR-T cell therapy to obtain approval.

The global, randomised, open-label, multi-centre Phase III trial analysed the efficacy, safety and tolerability of Kymriah against standard-of-care (SOC) in patients enrolled at more than 73 sites in 18 countries.

Salvage chemotherapy was the SOC, which was followed by high-dose chemotherapy and hematopoietic stem cell transplant (HSCT) in responding subjects.

Data showed that the trial failed to meet its primary goal of event-free survival (EFS), determined as the time from randomisation to the first recorded disease progression or stable disease at or following the week 12 analysis or death at any time.

Novartis noted that Kymriah’s safety profile in the trial was in line with the previously reported data.

Novartis Oncology and Hematology Development global head Jeff Legos said: “Patients with aggressive B-cell non-Hodgkin lymphoma who are refractory to first-line treatment are vulnerable and we are disappointed that the BELINDA study did not meet its primary endpoint in this setting.

“Kymriah continues to demonstrate durable responses for patients with certain advanced blood cancers in the third-line setting.”

The company noted that Kymriah is efficacious in currently approved indications and provides the potential for lasting responses and a favourable safety profile in clinical and real-world settings in more than 5,300 people so far.

Earlier this year, Novartis reported that the primary analysis of the Phase II ELARA trial of Kymriah showed a complete response rate of 66% in relapsed or refractory follicular lymphoma patients.

The company is now working towards regulatory filings of the drug for follicular lymphoma in the second half of this year.

Cell & Gene Therapy Coverage on Clinical Trials Arena supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

Free Whitepaper
img

Secure the cell therapy supply chain from bench to bedside

The development of cell therapies is changing healthcare, delivering new hope to thousands of patients around the world. The vein-to-vein workflow for these therapies, however, is not without challenges, many of which will increase as we scale up to treat more patients. Download this free guide from Cytiva to learn more about the challenges and risks associated with the cryogenic supply chain for cell therapies, and how supply chain disruptions can best be mitigated.
by Cytiva Thematic

By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena