Kite Announces Two-Year Data for Yescarta® (Axicabtagene Ciloleucel) in
Patients With Refractory Large B-Cell Lymphoma
-- 39 Percent of Patients in Ongoing Response Two Years after a Single Infusion of Yescarta in
the ZUMA-1 Study; Median Overall Survival was Not Reached --
-- Data Presented at the Annual Meeting of the American Society of
Hematology (ASH) and Simultaneously Published in The Lancet Oncology --
Kite, a Gilead Company (Nasdaq: GILD), announced two-year efficacy and safety data from the pivotal ZUMA-1 trial of
Yescarta® (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum follow-up of two
years after a single infusion of Yescarta (median follow up of 27.1 months), 39 percent of patients were in an ongoing response.
This updated analysis with at least 24 months of follow-up was presented at the Annual Meeting of the American Society of
Hematology (ASH; Abstract #2967) and simultaneously published in The Lancet Oncology.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181202005058/en/
In October 2017, Yescarta became the first chimeric antigen receptor T (CAR T) cell therapy to be approved by the U.S. Food and
Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more
lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large
B-cell lymphoma (PMBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the
treatment of patients with primary central nervous system lymphoma. The U.S. Prescribing Information for Yescarta contains a Boxed
Warning regarding the risk of cytokine release syndrome (CRS) and neurologic toxicities; see below for Important Safety
Information.
At two years, the best objective response via investigator assessment (n=101) showed an overall response rate of 83 percent,
with 58 percent of patients having achieved a complete response. With a median follow-up of 27.1 months, 39 percent of patients
remained in response. Of the patients with an ongoing response at 12 months, 93 percent remained in response at 24 months. The
median duration of response was 11.1 months; the median duration of complete response was not reached. Median overall survival was
not reached.
“With aggressive cancers such as refractory large B-cell lymphoma, our primary goal is to extend the lives of patients,” said
Sattva S. Neelapu, MD, ZUMA-1 Co-Lead Investigator and Professor, Department of Lymphoma/Myeloma, Division of Cancer
Medicine at The University of Texas MD Anderson Cancer Center. “Outcomes with traditional standard of care for this
highly refractory patient population have been extremely poor. Nearly 40 percent of patients in ZUMA-1 remain in response and half
of the patients are still alive after at least two years of treatment with Yescarta.”
In the two-year analysis (n=108), Grade 3 or higher CRS and neurologic events were seen in 11 percent and 32 percent of
patients, respectively, and were generally reversible. Four patients developed new serious adverse events (occurring since the
previous August 11, 2017 data cutoff), none of which were related to Yescarta. No new Yescarta-related CRS or neurologic events or
deaths have occurred since the one-year analysis.
“The two-year point is a another major milestone for Yescarta, which has extended the lives of a significant number of patients
in ZUMA-1 and has yielded important learnings that inform further research and development of CAR T therapies,” said Alessandro
Riva, MD, Executive Vice President, Oncology Therapeutics and Head, Cell Therapy, Gilead Sciences. “These data are not only
significant for the lymphoma community, but also reinforce our leadership in cell therapy as we aim to transform the treatment of a
variety of cancers with other investigational therapies in our pipeline.”
Full study results are available in The Lancet Oncology:
Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm,
multicentre, phase 1–2 trial:
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30864-7/fulltext
U.S. Important Safety Information for Yescarta
BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES
- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in
patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe
or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
- Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients
receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment
with Yescarta. Provide supportive care and/or corticosteroids as needed.
- Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation
Strategy (REMS) called the Yescarta REMS.
CYTOKINE RELEASE SYNDROME (CRS): CRS occurred in 94% of patients, including 13% with ? Grade 3. Among patients who died
after receiving Yescarta, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration
was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and
chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and
ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and
hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Ensure that 2 doses of tocilizumab are available prior to
infusion of Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs
and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate
medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive
care, tocilizumab or tocilizumab and corticosteroids as indicated.
NEUROLOGIC TOXICITIES: Neurologic toxicities occurred in 87% of patients. Ninety-eight percent of all neurologic
toxicities occurred within the first 8 weeks, with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17
days. Grade 3 or higher occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache
(44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%) and anxiety (9%). Prolonged encephalopathy
lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures occurred with Yescarta. Fatal and
serious cases of cerebral edema have occurred in patients treated with Yescarta. Monitor patients at least daily for 7 days at
the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or
symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly.
YESCARTA REMS: Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS. The required components of the Yescarta
REMS are: Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements.
Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of 2 doses of
tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS.
Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer Yescarta are trained
about the management of CRS and neurologic toxicities. Further information is available at
www.YESCARTAREMS.com or 1-844-454-KITE (5483).
HYPERSENSITIVITY REACTIONS: Allergic reactions may occur. Serious hypersensitivity reactions including anaphylaxis may be
due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta.
SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 38% of patients,
and in 23% with ? Grade 3. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial
infections in 9%, and viral infections in 4%. Yescarta should not be administered to patients with clinically significant active
systemic infections. Monitor patients for signs and symptoms of infection before and after Yescarta infusion and treat
appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 36% of
patients and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum
antibiotics, fluids and other supportive care as medically indicated. Hepatitis B virus (HBV) reactivation, in some cases resulting
in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. Perform
screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.
PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and
Yescarta infusion. Grade 3 or higher cytopenias not resolved by Day 30 following Yescarta infusion occurred in 28% of patients and
included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after Yescarta infusion.
HYPOGAMMAGLOBULINEMIA: B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia occurred in 15% of
patients. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis and
immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Yescarta treatment has not been
studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting
chemotherapy, during Yescarta treatment, and until immune recovery following treatment.
SECONDARY MALIGNANCIES: Patients may develop secondary malignancies. Monitor life-long for secondary malignancies. In the
event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to
collect for testing.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status
or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta
infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or
potentially dangerous machinery, during this initial period.
ADVERSE REACTIONS: The most common adverse reactions (incidence ? 20%) include CRS, fever, hypotension, encephalopathy,
tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea,
hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.
About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of
innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell
therapies. For more information on Kite, please visit
www.kitepharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City,
California. For more information on Gilead Sciences, please visit the company’s website at
www.gilead.com.
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 possibility of unfavorable results from ongoing and
additional clinical trials involving Yescarta. 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 September 30, 2018,
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.
U.S. Prescribing Information for Yescarta, including BOXED WARNING and Medication Guide, is available
at
www.kitepharma.com and
www.gilead.com.
Yescarta is a registered trademark of Gilead Sciences, Inc., or its related companies.
For more information on Kite, please visit the company’s website at www.kitepharma.com.
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.
![](http://cts.businesswire.com/ct/CT?id=bwnews&sty=20181202005058r1&sid=mstr3&distro=nx&lang=en)
Sung Lee, Investors
(650) 524-7792
Nathan Kaiser, Media
(650) 522-1853
View source version on businesswire.com: https://www.businesswire.com/news/home/20181202005058/en/