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Kite's Tecartus™ (Brexucabtagene Autoleucel) Authorized by Health Canada for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

·8-min read

-- TECARTUS is First CAR T Therapy in Mantle Cell Lymphoma (MCL) and Kite Becomes the First Company with Multiple Authorized Cell Therapies in Canada --

MISSISSAUGA, ON, Oct. 28, 2021 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada), has received a Health Canada Notice of Compliance (NOC) for TECARTUS™ (brexucabtagene autoleucel). TECARTUS is a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory MCL after two or more lines of systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor.i

"This is Canada's first CAR T-cell therapy for Canadian patients with MCL," said Melissa Koomey, Vice President and General Manager, Gilead Canada. "It is a devastating and debilitating illness and Gilead is proud to be leading the development of these important cell therapy options and providing important new hope for this community."

The NOC is supported by data from the multinational, single-arm, Phase 2 open-label ZUMA-2 pivotal trial in patients with relapsed or refractory MCL 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 91 percent, with 65 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of TECARTUS.ii

"CAR T therapies modify a patient's T-cells – part of the body's immune system – to detect and fight cancer cells. Really, it is a custom-made therapy for each patient," said Dr. John Kuruvilla, MD, FRCPC, Hematologist in the Division of Medical Oncology and Hematology at the Princess Margaret Cancer Centre. "Today's announcement provides new hope and more options for patients living with mantle cell lymphoma."

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the "mantle zone" of the lymph node and predominantly affects men over the age of 60.iii Patients with relapsed or refractory MCL after two or more lines of systemic therapy including a BTK inhibitor have a poor prognosis, with a median overall survival of 6 to 10 months.iv MCL accounts for approximately 5 to 10 percent of newly diagnosed NHL cases per year.v Based on previous rates of diagnosis, in Canada it is estimated that up to 1,040 new cases of MCL were diagnosed in 2020.vi,vii

"The availability of a new treatment option for patients with this rare cancer is wonderful news," said Antonella Rizza, CEO, Lymphoma Canada. "It is great to see the progress in the treatment space for MCL that Canadian patients can benefit from."

TECARTUS is a CAR T-cell therapy, an individualized method of treatment that harnesses the body's own immune system to target cancer cells. The therapy uses the XLP™ manufacturing process that includes T cell enrichment, a necessary step in certain B cell malignancies in which circulating lymphoblasts are a common feature.

About ZUMA-2viii

ZUMA-2 is a multinational, single-arm, Phase 2 open-label pivotal trial. The study enrolled 74 adult patients with relapsed or refractory MCL who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor (ibrutinib or acalabrutinib). The treatment was manufactured for 71 patients and administered to 68 patients. The primary endpoint was objective response rate per the Lugano Classification (2014), defined as the combined rate of complete response and partial responses as assessed by an Independent Radiologic Review Committee.

The most common non-hematological adverse reactions (in ≥20%) include: pyrexia (94%), CRS (91%), hypotension (57%), encephalopathy (51%), fatigue (50%), tachycardias (45%), other pathogen infections (43%), chills (41%), hypoxia (40%), cough (39%), tremor (38%), musculoskeletal pain (35%), edema (35%), headache (35%), nausea (35%), motor dysfunction (33%), constipation (29%), diarrhea (28%), decreased appetite (26%), dyspnea (26%), rash (22%), insomnia (21%), pleural effusion (21%), aphasia (20%), hypertension (20%), and renal insufficiency (20%).ix Serious adverse reactions occurred in 65% of patients.x The most common serious adverse reactions (≥ 2%) include: encephalopathy (26%), other pathogen infection (22%), pyrexia (20%), CRS (15%), hypoxia (9%), aphasia (6%), renal insufficiency (6%), pleural effusion (5%), respiratory failure (5%), bacterial infections (4%), dyspnea (4%), fatigue (4%), nonventricular arrhythmia (4%), viral infections (4%), diarrhea (2%), hypertension (2%), motor dysfunction (2%), seizure (2%), tachycardia (2%), and thrombosis (2%).xi Grade 3 or higher adverse reactions were reported in 65% of patients. The most common Grade 3 or higher non-haematological adverse reactions included infections (32%) and encephalopathy (24%). The most common Grade 3 or higher haematological adverse reactions included neutropenia (99%), leukopenia (98%), lymphopenia (96%), thrombocytopenia (65%) and anaemia (56%). Grade 3 or higher prolonged cytopenias (still present at Day 30 or with an onset at Day 30 or beyond) following TECARTUS infusion occurred in 57% of patients and included neutropenia (41%), thrombocytopenia (39%), and anemia (18%).xii

Important Safety Information
The TECARTUS Product Monograph has a SERIOUS WARNINGS AND PRECAUTIONS BOX regarding the risks of:

  • Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS if a patient has active uncontrolled infection or inflammatory disorders, active graft-versus-host disease (GVHD) or unresolved serious adverse reactions from prior therapies. Monitor for CRS after treatment with TECARTUS. Provide supportive care, tocilizumab, or tocilizumab and corticosteroids, as needed.xiii

  • Neurologic adverse reactions, including life-threatening reactions, occurred in patients receiving TECARTUS, including concurrently with CRS or independently of CRS. Monitor for neurologic adverse reactions after treatment with TECARTUS. Provide supportive care, tocilizumab (if with concurrent CRS), or corticosteroids, as needed.xiv

TECARTUS should be administered by experienced health professionals at specialized treatment centres.xv

For all important safety information for TECARTUS, including contraindications, warnings and precautions, adverse reactions and drug interactions, please see the Canadian Product Monograph at www.gilead.ca.

About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc., and was established in Mississauga, Ontario, in 2006. For more information on Gilead Sciences, please visit the company's website at http://www.gilead.ca/.

Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Kite may not realize the potential benefits of Tecartus therapy and the possibility of unfavorable results from other ongoing and additional clinical studies involving Tecartus®. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

TECARTUS, XLP, KITE, the KITE LOGO, GILEAD, and the GILEAD LOGO are trademarks of Gilead Sciences, Inc., or its related companies.

Learn more about Gilead at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. For more information on Kite, please visit the company's website at www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

______________________________

i

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

ii

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

iii

Lymphoma Research Foundation. "Understanding Mantle Cell Lymphoma." Available at:
https://lymphoma.org/wp-content/uploads/2018/10/MantleCellLymphomaFact-Sheet.pdf. Accessed: April
20, 2021.

iv

Wang, M. et al. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N
Engl J Med 2020;382:1331-42.

v

Lymphoma Canada. NHL Subtypes. Available at: https://www.lymphoma.ca/lymphoma/non-hodgkin-
lymphoma/nhl-subtypes/#3
. Accessed: April 20, 2021.

vi

Canadian Cancer Society. Non-Hodgkin Lymphoma Statistics. Available at:
https://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/statistics/?region=on.
Accessed: April 20, 2021.

vii

Lymphoma Canada. NHL Subtypes. Available at: https://www.lymphoma.ca/lymphoma/non-hodgkin-
lymphoma/nhl-subtypes/#3
. Accessed: April 20, 2021.

viii

Wang, M. et al. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N
Engl J Med 2020;382:1331-42.

ix

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

x

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

xi

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

xii

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

xiii

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

xiv

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

xv

TECARTUS™ product monograph, June 8, 2021 (www.gilead.ca).

SOURCE Gilead Sciences Canada, Inc.

Cision
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View original content: http://www.newswire.ca/en/releases/archive/October2021/28/c6435.html

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