-- After More Than Four Years of Follow-up
in the Pivotal ZUMA-3 Study, Median Overall Survival (OS) was 26
Months and the OS Rate was 40% at 48 Months --
-- Survival Benefit was Seen Regardless of
Age, Prior Treatment or Subsequent Allogeneic Stem Cell Transplant
Status --
-- Data Being Presented at the 2024 American
Society of Clinical Oncology Annual Meeting --
Kite, a Gilead Company (Nasdaq: GILD), today announced updated,
four-year overall survival (OS) data from the pivotal ZUMA-3 study
evaluating the CAR T-cell therapy Tecartus® (brexucabtagene
autoleucel) in adult patients with relapsed or refractory B-cell
acute lymphoblastic leukemia (R/R B-ALL). The findings showed a
median OS of 25.6 months and a four-year OS rate of 40% (95% CI,
28-52) in all treated patients with a safety profile consistent
with that observed in the three-year analysis. The results were
presented today in a poster presentation (Abstract #6531) at the
2024 American Society of Clinical Oncology (ASCO) Annual
Meeting.
“B-cell acute lymphoblastic leukemia is a rare and aggressive
form of blood cancer associated with poor prognosis – with a median
survival of less than eight months in those with relapsed or
refractory disease – so to see 40% of these patients treated with
one infusion of Brexu-cel still alive after four years is
meaningful indeed,” said Olalekan O. Oluwole, MBBS, MD, MPH,
Associate Professor of Medicine, Hematology/Oncology at Vanderbilt
University and primary investigator for the study. “Additionally,
the duration of response and survival benefits were demonstrated
regardless of the patients’ subsequent allogeneic stem cell
transplant status.”
In the poster being presented, patients treated with the pivotal
dose of Tecartus in the pooled analysis Phase 1 and 2 (n=78), the
median follow-up time was 53.6 months (range 44.7-82.3) with 4-year
minimum follow-up. Among all treated patients, the median OS was
25.6 months, and 47 months in patients with complete remission or
complete remission with incomplete hematologic recovery (n=57), the
primary endpoint. In patients <26 years (n=15), median OS (95%
CI) was 23.2 months (9.0-NE) and was 26.0 months (15.9-NE) in
patients ≥26 years (n=63), OS was a key secondary endpoint. Median
OS (95% CI) in patients with one prior therapy (n=15) was 60.4
months (7.6-NE) and was 25.4 months (15.9-47.0) in patients with ≥2
prior therapies (n=63).
Medians for OS (95% CI) in patients with (n=38) and without
(n=40) prior blinatumomab were 15.9 (8.3-26.0) and 60.4 months
(18.6-NE), respectively (unbalanced patient characteristics and
small numbers limit interpretation of these results). Median OS
(95% CI) was 36.3 months (10.2-NE) in responders who went on to
subsequent allogeneic stem cell transplant (n=14) and 60.4 months
(23.2-NE) in those who did not (n=43). No new adverse events or
deaths occurred since the three-year analysis. Rates of infection
were Grade ≥3 and higher in patients over 26 years and in patients
with prior blinatumomab.
“We are pleased that Tecartus continues to demonstrate improved
survival outcomes after four years of follow-up in adult patients
who would otherwise have very few treatment options,” said Ibrahim
Elhoussieny, MD, Vice President, Medical Affairs, Kite. “Notably,
Tecartus numerically improved overall survival particularly for
patients when given in earlier lines of therapy, and is an
important treatment option for the large portion of adult B-ALL
patients who relapse or are refractory to other treatments. We look
forward to continuing to improve survival in more people with this
challenging blood cancer.”
About ZUMA-3
ZUMA-3 is an ongoing international multicenter (US, Canada,
Europe), single arm, open label, registrational Phase 1/2 study of
Tecartus in adult patients (≥18 years old) with ALL whose disease
is refractory to or has relapsed following standard systemic
therapy or hematopoietic stem cell transplantation. The primary
endpoint is the rate of overall complete remission or complete
remission with incomplete hematological recovery by central
assessment. Duration of remission and relapse-free survival,
overall survival, minimal residual disease (MRD) negativity rate,
and alloSCT rate were assessed as secondary endpoints.
About Acute Lymphoblastic
Leukemia
ALL is an aggressive and rare type of blood cancer that can also
involve the lymph nodes, spleen, liver, central nervous system and
other organs. While 80% of ALL occurs in children, it represents a
devastating disease in adults. In adults, B-cell precursor ALL is
the most common form, accounting for 75% of cases. Survival rates
in adults with R/R B-ALL are poor, with median OS at less than
eight months.
About Tecartus
Please see full FDA Prescribing Information, including BOXED
WARNING and Medication Guide. Tecartus is a CD19-directed
genetically modified autologous T cell immunotherapy indicated for
the treatment of:
- Adult patients with relapsed or refractory mantle cell lymphoma
(MCL). This indication is approved under accelerated approval based
on overall response rate and durability of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial.
- Adult patients with relapsed or refractory B-cell precursor
acute lymphoblastic leukemia (ALL).
U.S. IMPORTANT SAFETY INFORMATION
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC
TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES
- Cytokine Release Syndrome (CRS), including life-threatening
reactions, occurred in patients receiving Tecartus. Do not
administer Tecartus to patients with active infection or
inflammatory disorders. Treat severe or life-threatening CRS with
tocilizumab or tocilizumab and corticosteroids.
- Neurologic toxicities, including life-threatening reactions,
occurred in patients receiving Tecartus, including concurrently
with CRS or after CRS resolution. Monitor for neurologic toxicities
after treatment with Tecartus. Provide supportive care and/or
corticosteroids as needed.
- T-cell malignancies have occurred following treatment of
hematologic malignancies with BCMA- and CD19-directed genetically
modified autologous T-cell immunotherapies.
- Tecartus is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
Yescarta and Tecartus REMS Program.
Ensure that a minimum of two doses of tocilizumab are available
for each patient prior to infusion of Tecartus. Following infusion,
monitor patients for signs and symptoms of CRS daily for at least
seven days at the certified healthcare facility, and for four weeks
thereafter. 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 Events, including those that were fatal or
life-threatening, occurred following treatment with Tecartus.
Neurologic events occurred in 87% (68/78) of patients with ALL,
including ≥ Grade 3 in 35% of patients. The median time to onset
for neurologic events was seven days (range: 1 to 51 days) with a
median duration of 15 days (range: 1 to 397 days) in patients with
ALL. For patients with MCL, 54 (66%) patients experienced CRS
before the onset of neurological events. Five (6%) patients did not
experience CRS with neurologic events and eight patients (10%)
developed neurological events after the resolution of CRS.
Neurologic events resolved for 119 out of 134 (89%) patients
treated with Tecartus. Nine patients (three patients with MCL and
six patients with ALL) had ongoing neurologic events at the time of
death. For patients with ALL, neurologic events occurred before,
during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients;
respectively. Three patients (4%) had neurologic events without
CRS. The onset of neurologic events can be concurrent with CRS,
following resolution of CRS or in the absence of CRS.
The most common neurologic events (>10%) were similar in MCL
and ALL and included encephalopathy (57%), headache (37%), tremor
(34%), confusional state (26%), aphasia (23%), delirium (17%),
dizziness (15%), anxiety (14%), and agitation (12%). Serious events
including encephalopathy, aphasia, confusional state, and seizures
occurred after treatment with Tecartus.
Monitor patients daily for at least seven days for patients with
MCL and at least 14 days for patients with ALL at the certified
healthcare facility and for four weeks following infusion for signs
and symptoms of neurologic toxicities and treat promptly.
REMS Program: Because of the risk of CRS and neurologic
toxicities, Tecartus is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
Yescarta and Tecartus REMS Program which requires that:
- Healthcare facilities that dispense and administer Tecartus
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 two doses of tocilizumab
are available for each patient for infusion within two hours after
Tecartus infusion, if needed for treatment of CRS.
- Certified healthcare facilities must ensure that healthcare
providers who prescribe, dispense, or administer Tecartus are
trained in the management of CRS and neurologic toxicities. Further
information is available at www.YescartaTecartusREMS.com or
1-844-454-KITE (5483).
Hypersensitivity Reactions: Serious hypersensitivity
reactions, including anaphylaxis, may occur due to dimethyl
sulfoxide (DMSO) or residual gentamicin in Tecartus.
Severe Infections: Severe or life-threatening infections
occurred in patients after Tecartus infusion. Infections (all
grades) occurred in 56% (46/82) of patients with MCL and 44%
(34/78) of patients with ALL. Grade 3 or higher infections,
including bacterial, viral, and fungal infections, occurred in 30%
of patients with ALL and MCL. Tecartus should not be administered
to patients with clinically significant active systemic infections.
Monitor patients for signs and symptoms of infection before and
after Tecartus infusion and treat appropriately. Administer
prophylactic antimicrobials according to local guidelines.
Febrile neutropenia was observed in 6% of patients with MCL and
35% of patients with ALL after Tecartus infusion and may be
concurrent with CRS. The febrile neutropenia in 27 (35%) of
patients with ALL includes events of “febrile neutropenia” (11
(14%)) plus the concurrent events of “fever” and “neutropenia” (16
(21%)). In the event of febrile neutropenia, evaluate for infection
and manage with broad spectrum antibiotics, fluids, and other
supportive care as medically indicated.
In immunosuppressed patients, life-threatening and fatal
opportunistic infections have been reported. The possibility of
rare infectious etiologies (e.g., fungal and viral infections such
as HHV-6 and progressive multifocal leukoencephalopathy) should be
considered in patients with neurologic events and appropriate
diagnostic evaluations should be performed.
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 Tecartus
infusion. In patients with MCL, Grade 3 or higher cytopenias not
resolved by Day 30 following Tecartus infusion occurred in 55%
(45/82) of patients and included thrombocytopenia (38%),
neutropenia (37%), and anemia (17%). In patients with ALL who were
responders to Tecartus treatment, Grade 3 or higher cytopenias not
resolved by Day 30 following Tecartus infusion occurred in 20%
(7/35) of the patients and included neutropenia (12%) and
thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved
by Day 60 following Tecartus infusion occurred in 11% (4/35) of the
patients and included neutropenia (9%) and thrombocytopenia (6%).
Monitor blood counts after Tecartus infusion.
Hypogammaglobulinemia: B cell aplasia and
hypogammaglobulinemia can occur in patients receiving treatment
with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of
patients with MCL and 9% (7/78) of patients with ALL. Monitor
immunoglobulin levels after treatment with Tecartus and manage
using infection precautions, antibiotic prophylaxis, and
immunoglobulin replacement.
The safety of immunization with live viral vaccines during or
following Tecartus treatment has not been studied. Vaccination with
live virus vaccines is not recommended for at least six weeks prior
to the start of lymphodepleting chemotherapy, during Tecartus
treatment, and until immune recovery following treatment with
Tecartus.
Secondary Malignancies: Patients treated with TECARTUS
may develop secondary malignancies. T-cell malignancies have
occurred following treatment of hematologic malignancies with BCMA-
and CD19-directed genetically modified autologous T-cell
immunotherapies. Mature T-cell malignancies, including CAR-positive
tumors, may present as soon as weeks following infusions, and may
include fatal outcomes. 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 Tecartus
infusion. Advise patients to refrain from driving and engaging in
hazardous activities, such as operating heavy or potentially
dangerous machinery, during this period.
Adverse Reactions: The most common non-laboratory adverse
reactions (≥ 20%) were fever, cytokine release syndrome,
hypotension, encephalopathy, tachycardia, nausea, chills, headache,
fatigue, febrile neutropenia, diarrhea, musculoskeletal pain,
hypoxia, rash, edema, tremor, infection with pathogen unspecified,
constipation, decreased appetite, and vomiting. The most common
serious adverse reactions (≥ 2%) were cytokine release syndrome,
febrile neutropenia, hypotension, encephalopathy, fever, infection
with pathogen unspecified, hypoxia, tachycardia, bacterial
infections, respiratory failure, seizure, diarrhea, dyspnea, fungal
infections, viral infections, coagulopathy, delirium, fatigue,
hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema,
and paraparesis.
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.
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 acquired Kite in 2017.
Forward-Looking
Statements
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 ability of Gilead and Kite to initiate, progress or
complete clinical trials within currently anticipated timelines or
at all, and the possibility of unfavorable results from ongoing or
additional clinical studies, including those involving Tecartus
(such as the ZUMA-3 study); the risk that physicians may not see
the benefits of prescribing Tecartus; and any assumptions
underlying any of the foregoing. These and other risks,
uncertainties and factors are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024,
as filed with the U.S. Securities and Exchange Commission. These
risks, uncertainties and other factors could cause actual results
to differ materially from those referred to in the forward-looking
statements. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements. The
reader is cautioned that any such forward-looking statements are
not guarantees of future performance and is cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements are based on information currently
available to Gilead and Kite, and Gilead and Kite assume no
obligation and disclaim any intent to update any such
forward-looking statements.
Kite, the Kite logo, Tecartus, and GILEAD are
trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Kite, please visit
the company’s website at www.kitepharma.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social
media on X (@KitePharma) and LinkedIn.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240603095365/en/
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Gilead Media Public_Affairs@gilead.com
Gilead Sciences (NASDAQ:GILD)
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