KITE’S TECARTUS®▼ (AUTOLOGOUS ANTI-CD19-TRANSDUCED CD3+ CELLS) GRANTED CONDITIONAL MARKETING AUTHORISATION FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY INCLUDING A BRUTON’S TYROSINE KINASE (BTK) INHIBITOR

-- Pivotal ZUMA-2 Trial Met its Primary Endpoint with 93 Per Cent of 60 Patients in the Primary Analysis Set Responding To a Single Infusion of autologous anti CD19 transduced CD3+ cells --

-- First CAR T cell Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with More Than One Licensed Cell Therapy in Europe --

--New Option for Eligible Adult Patients in Europe as Autologous anti CD19 transduced CD3+ cells Granted Conditional European Marketing Authorisation for Relapsed and Refractory Mantle Cell Lymphoma --

London, UK – 16 December 2020 – Kite, a Gilead Company, today announced that the European Commission has granted conditional marketing authorisation for its autologous anti CD19 transduced CD3+ cells, a chimeric antigen receptor (CAR) T cell therapy, as a treatment for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

The conditional marketing authorisation is supported by the ongoing, multinational, single arm, Phase 2 open-label ZUMA-2 pivotal trial. This trial was conducted in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. ZUMA-2 demonstrated an overall response rate (complete or partial) of 93 percent of 60 patients in the primary analysis set as part of a pre-specified protocol criteria, with 67 percent of patients achieving a complete response. This was assessed by an Independent Radiologic Review Committee following a single infusion of autologous anti CD19 transduced CD3+ cells. A total of 74 patients were enrolled. The autologous anti CD19 transduced CD3+ cells were manufactured for 71 patients and administered to 68. Primary analysis was performed on the first 60 patients treated. In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15 percent (10) and 31 percent (21) of patients, respectively. Other Grade 3 or higher events were also observed.[i]

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node.[ii]^,[iii] Patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a BTK inhibitor have a poor prognosis, with a median overall survival of 6 to 12.5 months.¹ Each year around 500 people are diagnosed with MCL in the UK.[iv]  For UK patients, the 5-year relative survival from diagnosis of MCL is only 41.9%[v]

“With mantle cell lymphoma, there is still a significant way to go to ensure patients have the best possible chance of survival,” said Antonio Pagliuca, Professor of Stem Cell Transplantation at King’s College Hospital NHS Foundation Trust and Chief Medical and Scientific Adviser to the blood cancer charity Anthony Nolan. “The conditional marketing authorisation is an important step towards delivering on that unmet need and offering patients an important new option in their fight against this cancer. It is good news that we will be able to offer this option to eligible patients as soon as possible.”

“Kite is committed to bringing the potential of CAR T cell therapy to patients with haematological cancers, and as such, we are proud that our second cell therapy has been granted conditional marketing authorisation in Europe,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “I extend my thanks to the patient study participants, carers, clinical researchers, regulators and dedicated colleagues at Kite who helped make this possible.”

Ropinder Gill, Chief Executive from Lymphoma Action added, “We know just how hard it is for people when, faced with this kind of aggressive blood cancer, the possibilities for treatment are so limited. This decision will give another treatment option for some of them, bringing the possibility for remission and survival to them and their loved ones.”

[i] Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020;382:1331-1342.

[ii] Dreyling M. et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2017 July; 28 (4): iv62-iv71. 

[iii] Sharma S & Sweetenham J. Mantle Cell Lymphoma: Are New Therapies Changing the Standard of Care? EMJ Oncol. 2018;6{1}:109-119.

[iv] Lymphoma Action. Mantle Cell Lymphoma. 2020. Available at: https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/mantle-cell-lymphoma. Last accessed: July 2020

[v] HMRN Researchers.  Mantle Cell Lymphoma.  2016.  Available at: https://www.hmrn.org/statistics/disorders/27 . Last accessed: September 2020