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01-Feb-2019

NICE approves Novartis’ CAR-T therapy Kymriah® (tisagenlecleucel)&#9660 for DLBCL in adults following commercial agreement with NHS England

·         Kymriah® (tisagenlecleucel) will be available on the NHS in England and Wales to eligible patients with diffuse large B-cell lymphoma (DLBCL), via the Cancer Drugs Fund

 

·         Kymriah® (tisagenlecleucel) is the only CAR-T cell therapy available for NHS patients in England and Wales for two distinct blood cancers (DLBCL and ALL)

 

·         If left untreated, people with relapsed/refractory DLCBL have median life expectancy of around 6 months1

 

Camberley, February 01, 2019 Novartis today announced that Kymriah® (tisagenlecleucel) treatment for diffuse large B-cell lymphoma (DLBCL) in adults who did not respond to two or more previous treatments is to be made available for NHS patients in England and Wales following appraisal by NICE (National Institute for Health and Care Excellence). Funding will be via the Cancer Drugs Fund (CDF) following a commercial agreement with NHS England.

 

This decision follows the previous approval for Kymriah by NICE in September 2018 for paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.

 

DLBCL is an aggressive form of blood cancer with a critical need for additional therapies. DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for approximately 30-40% of NHL cases in the UK2 and approximately 5,500 new cases/year3. For patients who relapse or do not respond to existing therapies (relapsed/refractory patients), there are limited treatment options3. Survival rates are low for the majority of patients due to ineligibility for autologous stem cell transplant (ASCT) or because salvage chemotherapy or ASCT have failed1.

 

“Tisagenlecleucel has the potential to transform cancer treatment in patients with relapsed/refractory diffuse large B-cell lymphoma. Although the follow-up period of the pivotal JULIET trial is still relatively short, the results are nonetheless impressive” said Dr Adrian Bloor, Consultant Haematologist and Director of Stem Cell Transplantation, The Christie NHS Foundation Trust, Manchester.

 

“The context for these data is also very important in that the prognosis for patients with relapsed refractory disease treated with standard therapy is often very poor. Patients had limited treatment options and life expectancy was often measured in months rather than years. Today’s decision represents an important step forward in being able to treat lymphoma patients more effectively and hopefully also marks the beginning of a new era of innovative and effective therapies.”

 

The decision from NICE was based on the results of the ongoing pivotal JULIET trial for tisagenlecleucel, which most recently demonstrated median probabilities of 64% being relapse-free and 43% overall survival at 18 months in patients with relapsed/refractory (r/r) disease. The median duration of response has still not been reached.4

 

“We’re very pleased that this ground-breaking CAR-T cell therapy will now be available on the NHS for some people with diffuse large B-cell lymphoma. This is really good news for people affected by this type of lymphoma who, until now, have faced limited treatment options. The news offers patients and their families faced with a poor prognosis a more hopeful outlook” said Ropinder Gill, Chief Executive of Lymphoma Action.

 

“Today’s positive announcement regarding access to Kymriah treatment in England and Wales was secured as a result of our close working collaboration with NICE and NHS England, with all parties showing flexibility. In parallel we have been working with the specialist sites across England that have been selected to deliver CAR-T therapy for DLBCL to ensure that they are fully trained and ready to deliver this life-saving therapy to eligible patients” said Mari Scheiffele, General Manager of Novartis Oncology UK & Ireland.

 

“Kymriah is the only CAR-T therapy approved by NICE in more than one distinct blood cancer – lymphoma (DLBCL) and leukaemia (ALL), which demonstrates Novartis’ position at the forefront of this highly innovative therapeutic advance.”

 

About CAR-T therapy

CAR-T (Chimeric Antigen Receptor – T cell) therapy is different from typical small molecule or biologic therapies because it is manufactured for each individual patient using their own cells. During the treatment process, T cells are drawn from a patient's blood and reprogrammed in the laboratory to create T cells that are genetically coded to recognise and fight the patient's cancer cells.

 

About JULIET

JULIET is the first multi-center global registration study for tisagenlecleucel in adult patients with r/r DLBCL. JULIET, led by researchers at the University of Pennsylvania, is the largest and only registration study examining a CAR-T cell therapy in DLBCL, enrolling patients from 27 sites in 10 countries.

 

The latest analysis from the JULIET study of tisagenlecleucel in adult patients with r/r DLBCL provides a median follow-up of 19 months and showed prolonged durability of response in patients (n=99) who had previously been through multiple rounds of chemotherapy and unsuccessful stem cell transplants. The median overall response rate (ORR) after a median of 19 months of follow-up was 54% (95% CI, 43% - 64%; CR, 40%; partial response [PR], 13%) among patients who were followed for at least 3 months or discontinued earlier.4

 

The median duration of response (mDOR) was not reached at the time of analysis indicating most responders were still experiencing a response at the time of analysis. The median relapse-free probability, which was 66% (95% CI, 51%-78%) at 6 months, remained consistent at 64% (95% CI, 48%-76%) at the 12-month and 18-month analyses.4 Median overall survival (OS) for all infused patients was 11.1 months (95% CI, 6.6 months-NE) and not reached (95% CI, 21 months-NE) for patients in CR.4

 

The safety profile observed in this latest analysis from JULIET continued to be consistent with previous reports and no deaths occurred due to causes other than disease progression in this longer-term follow up analysis.4

 

Novartis Leadership in Immuno-Oncology

Novartis is at the forefront of investigational immunocellular therapy as the first pharmaceutical company to initiate global CAR-T trials, and has significantly invested in CAR-T research and worked with pioneers in the field. Tisagenlecleucel is the cornerstone of this strategy. Active research programmes are underway targeting other haematologic malignancies and solid tumours, and include efforts focused on next generation CAR-Ts with evolved manufacturing schemes and gene edited cells.

 

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

 

In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. In 2017 Novartis invested almost £30million in R&D and is a leading sponsor of clinical trials in the UK. For more information, please visit www.novartis.co.uk.

 

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Last Updated: 01-Feb-2019