Market Overview

Kite Announces New Data Analyses for CAR T Therapy in Patients with Blood Cancers at the 2018 American Society of Clinical Oncology Meeting


-- ZUMA-1 Data Suggest Patient Response to Yescarta®
(axicabtagene ciloleucel) at Three Months May be Predictive of
Longer-Term Response in Refractory B-cell Lymphoma --

-- ZUMA-3 Analysis Suggests High Complete Response Rates with
KTE-C19 in Adult Patients with Relapsed or Refractory Acute
Lymphoblastic Leukemia (ALL) Regardless of Prior Blinatumomab Treatment

Kite, a Gilead Company (NASDAQ:GILD), today announced new analyses from
the ZUMA chimeric antigen receptor T (CAR T) cell therapy development
program that are being presented at the 2018 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago. The results include
analyses of the ZUMA-1 study of Yescarta® (axicabtagene
ciloleucel) in adult patients with refractory large B-cell lymphoma
showing that response status may predict rates of progression-free
survival (PFS) (Abstract #3003) and that treatment responses were
consistent across prior lines of therapy (Abstract #3039). Additionally,
an analysis of the ZUMA-3 study evaluating investigational KTE-C19 for
the treatment of adult patients with relapsed or refractory acute
lymphoblastic leukemia (ALL) showed that patients experienced manageable
safety and encouraging efficacy irrespective of prior blinatumomab use
(Abstract #7006).

This press release features multimedia. View the full release here:

"With the U.S. approval of Yescarta last year, we aim to transform the
treatment of patients with refractory large B-cell lymphoma," said
Alessandro Riva, MD, Gilead's Executive Vice President, Oncology
Therapeutics & Head, Cell Therapy. "We are also committed to studying
Yescarta and other CD19-directed CAR T therapies for people with other
relapsed or refractory blood cancers. Based on the strength of the
ZUMA-1 data, we are now evaluating the potential of Yescarta in the
second-line treatment setting in a Phase 3 study, ZUMA-7, and we
continue to evaluate KTE-C19 in Phase 1/2 studies in ALL and other
hematologic cancers."

Yescarta was the first 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, 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.

Yescarta has a Boxed Warning in its product label and an associated Risk
Evaluation and Mitigation Strategy (REMS) regarding the risks of CRS and
neurologic toxicities. Please see below for Important Safety Information.

A Marketing Authorization Application (MAA) for axicabtagene ciloleucel
is currently under review with the European Medicines Agency (EMA).

Ongoing Responses, Response by Prior Lines of Therapy in ZUMA-1
(Abstracts #3003 and #3039)

Long-term ZUMA-1 follow-up data have shown an overall response rate
(ORR) of 83 percent (n=84/101), including 58 percent (n=59/101) of
patients with a complete response at a median follow-up of 15.1 months.
In this long-term follow-up, Grade 3 or higher cytokine release syndrome
(CRS) and neurologic events were seen in 12 percent and 29 percent of
patients, respectively.

A new analysis of ZUMA-1 suggests that response status three months
after infusion of Yescarta may be predictive of longer-term disease
control. Of the 42 patients with complete response and nine with partial
response at three months, the 12-month PFS rates were 79 percent and 78
percent, respectively. This abstract has also been selected for
inclusion in the 2018 Best of ASCO® program.

"We are encouraged by the strong long-term complete response rates in
ZUMA-1, which represents a patient population that previously had few if
any remaining treatment options," said Frederick L. Locke, MD, ZUMA-1
Co-Lead Investigator and Vice Chair of the Department of Blood and
Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in
Tampa, Florida. "Importantly, this new study analysis indicates that
response status at three months is potentially predictive of prolonged

An additional ZUMA-1 analysis evaluated outcomes based on prior therapy
the patients had received. The results indicate long-term clinical
benefit for patients with refractory large B cell lymphoma, irrespective
of the number of prior lines of therapy.

Rates of Response with Prior Blinatumomab Treatment in ZUMA-3
(Abstract #7006)

Phase 1 data for KTE-C19, an investigational CD19 CAR T cell therapy,
presented at the 2017 Annual Meeting of the American Society of
Hematology (ASH) demonstrated high rates of complete response in adult
patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
A new analysis of data from the ZUMA-3 study shows patients responded to
KTE-C19 regardless of prior treatment with blinatumomab, an FDA-approved
treatment for relapsed or refractory ALL. After eight or more weeks of
follow-up, 63 percent (n=5/8) of patients with prior blinatumomab
treatment and 80 percent (n=8/10) of patients without prior blinatumomab
treatment had achieved a complete response or complete response with
incomplete hematological recovery. Overall, 94 percent (n=17/18) of
patients had minimal residual disease (MRD)-negative remission. KTE-C19
was also manufactured successfully in both groups, with similar product
characteristics in terms of CD4/CD8 ratio and other measures.

"As a CD19/CD3 bispecific T cell antibody, the possible impact of prior
blinatumomab use on the efficacy of KTE-C19 – a CD19-directed CAR T
therapy – was an important question for exploration," said Bijal Shah,
MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center.
"We observed that prior blinatumomab use did not affect the
manufacturing of efficacious product, and that high response rates were
seen regardless of previous treatment with blinatumomab."

Grade 3 or higher CRS was seen in 27 percent of patients with prior
blinatumomab and in 17 percent of patients without prior blinatumomab.
Grade 3 or higher neurologic events were seen in 36 percent of patients
with prior blinatumomab and 67 percent of patients without prior
blinatumomab. A greater number of subjects in the blinatumomab-naïve
group received the higher 1 × 106 cells/kg dose.

KTE-C19 for ALL is investigational and has not been proven safe or

U.S. Important Safety Information for Yescarta


  • 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
  • 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

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
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.

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.

Please see accompanying full Prescribing Information, including BOXED
and Medication Guide.

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

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

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 Kite's
ability to complete the Phase 3 study of Yescarta for the treatment of
relapsed or refractory large B-cell lymphoma (ZUMA-7) and the Phase 1/2
studies of KTE-C19 for the treatment of acute lymphoblastic leukemia and
other hematologic cancers in the currently anticipated timelines, or at
all. In addition, there is the possibility of unfavorable results from
additional clinical trials involving Yescarta and KTE-C19. Further, Kite
may be unable to obtain regulatory approval for axicabtagene ciloleucel
from the European Commission or other regulatory authorities. 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 March 31, 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

US Prescribing Information for Yescarta, including BOXED WARNING and
Medication Guide, is available at

For more information on Kite, please visit the company's website at
Learn more about Gilead at,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.

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