KITE'S YESCARTA® (AXICABTAGENE CILOLEUCEL) FIRST CAR T-CELL THERAPY TO RECEIVE HEALTH CANADA AUTHORIZATION FOR USE IN SECOND-LINE LARGE B-CELL LYMPHOMA

- First LCBL Treatment to Improve Upon Standard of Care in Nearly 30 Years –

- Landmark ZUMA-7 Study Demonstrated Patients on YESCARTA Were 2.5 Times More Likely to Be Alive at 18-months Without Cancer Progression or Need for Additional Cancer Treatmentⁱ –

MISSISSAUGA, ON, March 23, 2023 /CNW/ - Gilead Sciences Canada, Inc., (Gilead Canada) and Kite, a Gilead Company today announced they have received a Health Canada Notice of Compliance (NOC) for YESCARTA^® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.ⁱⁱ DLBCL and HGBL are two forms of large B-cell lymphoma (LBCL). This decision marks the first marketing authorization in Canada for a CAR T-cell therapy to be used earlier, as a second-line LBCL treatment.

"Today's announcement brings new hope to more patients with DLBCL and HGBL by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey," said Christophe Griolet, Vice President and General Manager, Gilead Sciences Canada. "In the ZUMA-7 trial, YESCARTA demonstrated a clinically meaningful impact for patients with relapsed or refractory LBCL and we are committed to working with governments to ensure timely and sustainable access for eligible patients in urgent need." 

LBCL is the most common form of non-Hodgkin's Lymphoma (a type of cancer that originates primarily in white blood cells) and accounts for approximately 30 to 40 per cent of newly diagnosed cases.ⁱⁱⁱ Based on previous rates of diagnosis, in Canada it is estimated that up to 4,560 new cases of LBCL will be diagnosed in 2022.^iv,v The prognosis for relapsed or refractory adult patients is very poor, with a median survival of just six months.^vi

"The Health Canada authorization of YESCARTA for second-line treatment of Canadians with relapsed or refractory DLBCL or HGBL establishes a new curative standard of care treatment paradigm for patients that previously would have been eligible for salvage chemotherapy and autologous stem cell transplantation," said Dr. John Kuruvilla, MD, FRCPC, ZUMA-7 Investigator and Hematologist in the Division of Medical Oncology and Hematology at the Princess Margaret Cancer Centre. "Patients who experience early progression of their lymphoma after initial treatment finally have a new and effective treatment option that has been shown through the ZUMA-7 trial to provide superior response rates and event-free survival than the current standard of care."

YESCARTA demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care (SOC) that has been in place for decades.^vii Additionally, 2.5 times more patients who received a one-time infusion of YESCARTA (41.5%) were alive at 18-months without disease progression or need for additional cancer treatment vs. SOC (17%), and the median EFS was four-fold greater (8.3 months vs. 2.0 months) with YESCARTA vs. SOC.^viii ZUMA-7 is considered a landmark trial for being the first and largest trial of its kind, with the longest follow-up.

SOC therapy for this patient population has historically been a multi-step process that is expected to end with a stem cell transplant. The process starts with chemoimmunotherapy, and if a patient responds to and can tolerate further treatment, they move on to high-dose chemotherapy (HDT) followed by an autologous stem cell transplant (ASCT).

"For Canadians living with LBCL, the risk of relapse and uncertainty about which treatment options will be available adds stress to an already anxious time in their lives," said Antonella Rizza, CEO at Lymphoma Canada. "We are so pleased that patients will have access to CAR T-cell therapy for second-line treatment, expanding the available options for Canadians with LBCL."

About YESCARTA
YESCARTA is a CAR T therapy, an individualized method of treatment that harnesses the power of the body's own immune system to target cancer cells. In CAR T therapy, T cells (a type of white blood cell) are removed from a patient (a process called apheresis) and modified so they can recognize and respond to a specific antigen, which is identified on cancer cells and signals cell death.^ix Gilead Sciences Canada received Health Canada authorization for YESCARTA in this indication in February, 2019. 

About ZUMA-7^x
ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of YESCARTA versus current SOC for second-line therapy (chemoimmunotherapy regimen followed by high-dose therapy [HDT] and ASCT in those who respond to chemotherapy) in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. Results were published in the New England Journal of Medicine (NEJM) in December 2021.

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

• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Delay YESCARTA treatment 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 YESCARTA. Provide supportive care, tocilizumab, or tocilizumab and corticosteroids, as needed (see WARNINGS AND PRECAUTIONS).
• Neurologic adverse reactions, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or independently of CRS. Monitor for neurologic adverse reactions after treatment with YESCARTA. Provide supportive care, tocilizumab (if with concurrent CRS), or corticosteroids, as needed (see WARNINGS AND PRECAUTIONS).
• YESCARTA should be administered by experienced health professionals at specialized treatment centres (see WARNINGS AND PRECAUTIONS).

For all important safety information for YESCARTA, 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, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing. For more information on Kite, please visit www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

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 www.gilead.com.

Kite, the Kite logo, YESCARTA, 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.

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	^i YESCARTA® Product Monograph, December 6, 2022 (www.gilead.ca)
	^iiIbid.
	^iii Menon M. et al. The Histological and Biological Spectrum of Diffuse Large B-cell Lymphoma in the WHO Classification. Cancer J. 2012 Sept;18(5):411–420.
	^iv Ibid.
	^v 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 on: December 2, 2022.
	^viCrump M. et al, Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017 Oct. 130(16): 1800–1808.
	^vii YESCARTA® Product Monograph, December 6, 2022 (www.gilead.ca)
	^viii Ibid.
	^ix Leukemia & Lymphoma Society (LLS). Chimeric antigen receptor (CAR) T-cell therapy. 2019. Available at: https://www.lls.org/treatment/types-of-treatment/immunotherapy/chimeric-antigen-receptor-car-t-cell-therapy. Accessed: December 15, 2022.
	^x ClinicalTrials.gov. Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7). Available at: https://clinicaltrials.gov/ct2/show/NCT03391466?term=ZUMA+7&draw=2&rank=1 Accessed on: December 15, 2022.
	^xi YESCARTA® Product Monograph, December 6, 2022 (www.gilead.ca)

SOURCE Gilead Sciences Canada

Andrew Forgione, Public Affairs, [email protected]