REG - Syncona Limited - Autolus receives US FDA approval

SynconaAnnouncement

11/11/2024 07:00

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RNS Number : 6161L  Syncona Limited  11 November 2024

11 November 2024

 

Syncona Limited

 

Autolus receives US FDA approval for AUCATZYL(®) (obe-cel)

 

Syncona Ltd, ("Syncona") a leading life science investor focused on creating,
building and scaling global leaders in life science, today notes that its
portfolio company Autolus Therapeutics ("Autolus"), an early-commercial stage
biopharmaceutical company developing next-generation programmed T cell
therapies, has announced that the U.S. Food and Drug Administration (FDA) has
granted marketing approval for AUCATZYL(®) (obe-cel) for the treatment of
adult patients with relapsed or refractory B-cell precursor acute
lymphoblastic leukaemia (r/r B-ALL).

 

Key highlights are as follows:

 

·      The approval of AUCATZYL was based on results from the FELIX
clinical trial of obe-cel in r/r B-ALL

·      The FELIX trial confirmed a strong safety profile compared to
current CD19 CAR T-cell therapies, with AUCATZYL the first CAR T-cell therapy
to be approved by the FDA with no requirement for a Risk Evaluation and
Mitigation Strategy programme, which is implemented for drugs with serious
safety concerns

·      ALL is an aggressive type of blood cancer where there are
approximately 8,400 new cases diagnosed every year in the US and EU, with
around 3,000 of these patients in the relapsed refractory setting 1 

·      Survival rates are very poor in adult r/r ALL, with a median
overall survival of eight months 2 

·      In the 65 patients in the FELIX trial where efficacy could be
evaluated, 63% achieved overall complete remission, representing the
elimination of all signs of cancer in response to treatment

·      Complete remission within three months was achieved in 42% of
patients, with a median duration of remission of 14.1 months

·      AUCATZYL will be manufactured at Autolus' commercial
manufacturing site in Stevenage, UK, which will supply the therapy globally

 

Chris Hollowood, CEO of Syncona Investment Management Limited, said: "We are
delighted for Autolus to receive FDA approval for its novel CAR T-cell therapy
for the treatment of adult ALL. Adult ALL is a devastating disease and
AUCATZYL will bring a much-needed new treatment option to patients suffering
from the condition. This is a proud moment for Syncona. We co-founded Autolus
in 2014 and it is the first company we have supported from the academic bench
through to regulatory approval. We would like to congratulate the Autolus
team, as well as those that have worked alongside the company, to help it
reach this important milestone."

 

Autolus management will host a conference call and webcast on 11 November
at 8:30 EST / 13:30 GMT, to discuss the AUCATZYL approval. To listen to the
webcast, please go to: https://www.autolus.com/investor-relations/events/
(https://www.autolus.com/investor-relations/events/)

 

The announcement can be accessed on Autolus' investor website at
https://www.autolus.com/investor-relations/news/
(https://www.autolus.com/investor-relations/news/) and the full text of the
announcement from Autolus is contained below.

 

 ENDS 

 

Enquiries

 

Syncona Ltd

 

Natalie Garland-Collins / Fergus Witt

Tel: +44 (0) 20 3981 7912

 

FTI Consulting

 

Ben Atwell / Tim Stamper

Tel: +44 (0) 20 3727 1000

 

About Syncona

 

Syncona's purpose is to invest to extend and enhance human life. We do this by
creating, building and scaling companies to deliver transformational
treatments to patients in areas of high unmet need.

We aim to build and maintain a diversified portfolio of 20-25 globally leading
life science businesses, across development stage, modality and therapeutic
area, for the benefit of all our stakeholders. We focus on developing
treatments that deliver patient impact by working in close partnership with
world-class academic founders and experienced management teams. Our balance
sheet underpins our strategy, enabling us to take a long-term view as we look
to improve the lives of patients with no or poor treatment options, build
sustainable life science companies and deliver strong risk-adjusted returns to
shareholders.

Syncona Limited seeks to achieve returns over the long term. Investors should
seek to ensure they understand the risks and opportunities of an investment in
Syncona Limited, including the information in our published documentation,
before investing.

 

 

Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene
autoleucel - obe-cel) for adults with relapsed/refractory B-cell acute
lymphoblastic leukemia (r/r B-ALL)

 

-       AUCATZYL is the first CAR T therapy approved by the FDA with no
requirement for a REMS program (Risk Evaluation Mitigation Strategy)

-       Approval based on FELIX clinical trial of obe-cel in adult
patients with r/r B-ALL

-       Conference call to be held on November 11 at 08:30 am EDT/13:30
pm BST: conference call participants should pre-register using the link at the
bottom of this press release

 

LONDON, November 8, 2024 -- Autolus Therapeutics plc (Nasdaq: AUTL), an
early-commercial stage biopharmaceutical company developing next-generation
programmed T cell therapies, today announces the U.S. Food and Drug
Administration (FDA) has granted marketing approval for AUCATZYL®
(obecabtagene autoleucel) for the treatment of adult patients with relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

 

"Adult ALL is an extremely aggressive cancer, and there is a high unmet
medical need that exists in the treatment of patients with this disease once
they relapse, where historically they suffer from poor outcomes," said Elias
Jabbour, MD, U.S. lead investigator of the FELIX study and professor of
Leukemia, ALL Section Chief, at The University of Texas MD Anderson Cancer
Center, Houston, Texas.  "This milestone approval, based on the demonstrated
clinical benefit of AUCATZYL, brings new hope for adult patients with
relapsed/refractory B-ALL."

 

AUCATZYL was approved by the FDA based on results from the FELIX clinical
trial of obe-cel in adult patients with r/r B-ALL. In the morphological
disease cohort, 94 patients received at least one infusion of AUCATZYL of
which 65 patients had > 5% blasts in the bone marrow after screening and
prior to the start of lymphodepletion therapy and received a conforming
product, qualifying them as efficacy evaluable. In the efficacy evaluable
patients (n=65), 63% achieved overall complete remission (OCR(( 3  (#_ftn3)
))) which includes 51% of patients with CR at any time and 12% patients with
CRi at any time. The major efficacy outcome was complete remission within 3
months, which was achieved in 42% patients, and the median duration of
remission (DOR) was 14.1 months. AUCATZYL showed low levels of Cytokine
Release Syndrome (CRS), with 3% Grade 3 events, and no Grade 4 or 5 events.
Grade ≥ 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was
reported in 7% of patients. No REMS was required by the FDA for AUCATZYL.

 

The safety of AUCATZYL includes a boxed warning for CRS, neurologic
toxicities, and secondary hematological malignancies. ICANS, including fatal
or life-threatening reactions, occurred in patients receiving AUCATZYL. T-cell
malignancies have occurred following treatment of hematologic malignancies
with BCMA- and CD19-directed genetically modified autologous T-cell
immunotherapies. In the FELIX trial, the most common non-laboratory adverse
reactions (incidence ≥ 20%) included CRS, infections-pathogen unspecified,
musculoskeletal pain, viral infections, fever, nausea, bacterial infectious
disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue,
headache, encephalopathy, and hemorrhage.

 

"Based on the experience in the FELIX trial AUCATZYL is highly active and can
be well managed, offering an attractive risk benefit profile for B-ALL
patients." said Dr. Claire Roddie, MD, PhD, FRCPath, Lead investigator of
the FELIX study and Associate Professor of Haematology at the University
College London (UCL) Cancer Institute. "In the FELIX trial AUCATZYL has shown
long term persistence and deep responses which we believe are critical for
long term remissions in B-ALL."

 

"We are so pleased to now be able to offer AUCATZYL, our first commercial
product, to adult r/r B-ALL patients in the U.S. This approval would not have
been possible without the support of all the patients, their families and
caregivers, their treating physicians and the nurses and investigators at the
treatment centers - thank you" said Dr. Christian Itin, Chief Executive
Officer of Autolus. "This milestone is the culmination of many years of hard
work, the foundational work by our partners at UCL and the unwavering
commitment of our internal team, our external partners and shareholders. This
is a proud day for Autolus."

 

AUCATZYL will be manufactured at Autolus' dedicated commercial manufacturing
site, the Nucleus, in Stevenage, UK. The site was granted a Manufacturer's
Importation Authorization (MIA) and a GMP certificate from the U.K. Medicines
and Healthcare products Regulatory Agency (MHRA) in March 2024, and was
inspected as part of the FDA approval process. No major or critical
observations were identified by either the MHRA or FDA during the site
inspections. The Nucleus will supply AUCATZYL globally, with Cardinal Health
serving as Autolus' commercial distribution partner in the U.S. Autolus will
now engage with existing treatment centers to complete the onboarding process
and initiate the first scheduling of patients to make AUCATZYL commercially
available in the U.S.

 

ALL is an aggressive type of blood cancer that can also involve the lymph
nodes, spleen, liver, central nervous system and other organs. Approximately
8,400 new cases of adult ALL are diagnosed every year in the US and EU, with
around 3,000 patients in the relapsed refractory setting.(1) Survival rates
remain very poor in adult patients with r/r ALL, with median overall survival
of eight months.(2) In frontline treatment for adult r/r B-ALL, up to 50% of
patients will ultimately relapse, and the standard-of-care treatment can
trigger severe toxicities and may be burdensome for some patients.(3,4)

 

Marketing authorisation applications (MAAs) for obe-cel in adult r/r ALL are
being reviewed by the regulators in both the EU and the UK, with a submission
to the European Medicines Agency (EMA) accepted in March 2024, and a
submission accepted by the UK MHRA in August 2024.

 

Conference Call

Management will host a conference call and webcast on November 11 at 8:30 am
EDT/1:30 pm BST to discuss the AUCATZYL approval. Conference call participants
should pre-register using this link
(https://register.vevent.com/register/BI94bdc7eff14843bc8afee9326f56ee72) to
receive the dial-in numbers and a personal PIN, which are required to access
the conference call.

 

A simultaneous audio webcast and replay will be accessible on the events
section (https://www.autolus.com/investor-relations/news-and-events/events) of
Autolus' website.

 

About Autolus Therapeutics plc

Autolus is a biopharmaceutical company developing next-generation, programmed
T cell therapies for the treatment of cancer and autoimmune disease. Using a
broad suite of proprietary and modular T cell programming technologies,
Autolus is engineering precisely targeted, controlled and highly active T cell
therapies that are designed to better recognize target cells, break down their
defense mechanisms and eliminate these cells. Autolus has an FDA approved
product, AUCATZYL, and a pipeline of product candidates in development for the
treatment of hematological malignancies, solid tumors and autoimmune diseases.
For more information, please visit www.autolus.com (http://www.autolus.com)

 

About AUCATZYL® (obecabtagene autoleucel, obe-cel, AUTO1)

AUCATZYL is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR)
T cell therapy designed to overcome the limitations in clinical activity and
safety compared to current CD19 CAR T cell therapies. AUCATZYL is designed
with a fast target binding off-rate to minimize excessive activation of the
programmed T cells. AUCATZYL was approved by the FDA for the treatment of
adult patients with relapsed or refractory B-cell precursor acute
lymphoblastic leukemia on November 16, 2024. In the EU a regulatory submission
to the EMA was accepted in April 2024, while in the UK, an MAA was submitted
to MHRA in July 2024.

 

INDICATION

AUCATZYL(®) is a CD19-directed genetically modified autologous T cell
immunotherapy indicated for the treatment of adult patients with relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL).

 

IMPORTANT SAFETY INFORMATION

  WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY
 HEMATOLOGICAL MALIGNANCIES

 ·      Cytokine Release Syndrome (CRS) occurred in patients receiving
 AUCATZYL. Do not administer AUCATZYL to patients with active infection or
 inflammatory disorders. Prior to administering AUCATZYL, ensure that
 healthcare providers have immediate access to medications and resuscitative
 equipment to manage CRS.

 ·      Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS),
 including fatal and life-threatening reactions, occurred in patients receiving
 AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for
 neurologic signs and symptoms after treatment with AUCATZYL. Prior to
 administering AUCATZYL, ensure that healthcare providers have immediate access
 to medications and resuscitative equipment to manage neurologic toxicities.
 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.

 

WARNINGS AND PRECAUTIONS

 

Cytokine Release Syndrome (CRS)

Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL.
CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of
patients. The median time to onset of CRS was 8 days following the first
infusion (range: 1 to 23 days) with a median duration of 5 days (range: 1 to
21 days). The most common manifestations of CRS included fever (100%),
hypotension (35%), and hypoxia (19%).

 

Prior to administering AUCATZYL, ensure that healthcare providers have
immediate access to medications and resuscitative equipment to manage CRS.
During and following treatment with AUCATZYL, closely monitor patients for
signs and symptoms of CRS daily for at least 14 days at the healthcare
facility following the first infusion. Continue to monitor patients for CRS
for at least 4 weeks following each infusion with AUCATZYL. Counsel patients
to seek immediate medical attention should signs or symptoms of CRS occur at
any time. At the first sign of CRS, immediately evaluate the patient for
hospitalization and institute treatment with supportive care based on severity
and consider further management per current practice guidelines.

 

Neurologic Toxicities

Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity
Syndrome (ICANS), which were fatal or life-threatening, occurred following
treatment with AUCATZYL. Neurologic toxicities were reported in 64% (64/100)
of patients, including Grade ≥ 3 in 12% of patients. The median time to
onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a
median duration of 13 days (range: 1 to 904 days). Among patients with
neurologic toxicities, the most common symptoms (> 5%) included ICANS
(38%), headache (34%), encephalopathy (33%), dizziness (22%), tremor (13%),
anxiety (9%), insomnia (9%), and delirium (8%).

 

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)

ICANS events occurred in 24% (24/100) of patients, including Grade ≥ 3 in 7%
(7/100) of patients. Of the 24 patients who experienced ICANS, 33% (8/24)
experienced an onset after the first infusion, but prior to the second
infusion of AUCATZYL.

The median time to onset for ICANS events after the first infusion was 8 days
(range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) after the second
infusion, with a median duration of 8.5 days (range: 1 to 53 days).

Eighty-eight percent (21/24) of patients received treatment for ICANS. All
treated patients received high-dose corticosteroids and 42% (10/24) of
patients received anti-epileptics prophylactically. Prior to administering
AUCATZYL, ensure that healthcare providers have immediate access to
medications and resuscitative equipment to manage ICANS.

 

Counsel patients to seek medical attention should signs or symptoms of
neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity
/ICANS, immediately evaluate patients for hospitalization and institute
treatment with supportive care based on severity and consider further
management per current practice guidelines.

 

Effect on Ability to Drive and Use Machines

Due to the potential for neurologic events, including altered mental status or
seizures, patients receiving AUCATZYL are at risk for altered or decreased
consciousness or coordination in the eight weeks following AUCATZYL infusion
or until resolution of the neurological event by the treating physician.
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.

 

Prolonged Cytopenias

Patients may exhibit cytopenias including anemia, neutropenia, and
thrombocytopenia for several weeks after treatment with lymphodepleting
chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade
≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were
observed in 71% (29/41) of patients and included neutropenia (66%, 27/41) and
thrombocytopenia (54%, 22/41). Grade 3 or higher cytopenias that persisted
beyond Day 60 following AUCATZYL infusion was observed in 27% (11/41) of
patients and included neutropenia (17%, 7/41) and thrombocytopenia (15%,
6/41). Monitor blood counts after AUCATZYL infusion.

 

Infections

Severe, including life-threatening and fatal infections occurred in patients
after AUCATZYL infusion. Non‑COVID-19 infections of all grades occurred in
67% (67/100) of patients. Grade 3 or higher non-COVID-19 infections occurred
in 41% (41/100) of patients. AUCATZYL should not be administered to patients
with clinically significant active systemic infections. Monitor patients for
signs and symptoms of infection before and after AUCATZYL infusion and treat
appropriately. Administer prophylactic antimicrobials according to local
guidelines.

 

Grade 3 or higher febrile neutropenia was observed in 26% (26/100) of patients
after AUCATZYL infusion 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.

 

Viral reactivation, potentially severe or life-threatening, can occur in
patients treated with drugs directed against B cells. There is no experience
with manufacturing AUCATZYL for patients with a positive test for human
immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active
hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance
with clinical guidelines before collection of cells for manufacturing.

 

Hypogammaglobulinemia

Hypogammaglobulinemia and B-cell aplasia can occur in patients after AUCATZYL
infusion. Hypogammaglobulinemia was reported in 10% (10/100) of patients
treated with AUCATZYL including Grade 3 events in 2 patients (2%).

 

Immunoglobulin levels should be monitored after treatment with AUCATZYL and
managed per institutional guidelines including infection precautions,
antibiotic or antiviral prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following
treatment with AUCATZYL has not been studied. Vaccination with live viral
vaccines is not recommended for at least 6 weeks prior to the start of
lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until
immune recovery following treatment with AUCATZYL.

 

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)

HLH/MAS including fatal and life-threatening reactions occurred after
treatment with AUCATZYL. HLH/MAS was reported in 2% (2/100) of patients and
included Grade 3 and Grade 4 events with a time of onset at Day 22 and Day 41,
respectively. One patient experienced a concurrent ICANS events after AUCATZYL
infusion and died due to sepsis with ongoing HLH/MAS that had not resolved.
Administer treatment for HLH/MAS according to institutional standards.

 

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, may occur due to
dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for
hypersensitivity reactions during and after AUCATZYL infusion.

 

Secondary Malignancies

Patients treated with AUCATZYL 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 infusion, and may include fatal
outcomes. Monitor lifelong for secondary malignancies. In the event that a
secondary malignancy occurs, contact Autolus at 1-855-288-5227 for reporting
and to obtain instructions on the collection of patient samples for testing.

 

Adverse Reactions

The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients
with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL)
received AUCATZYL at a median dose of 410 × 10(6) CD19 CAR-positive viable T
cells (range: 10 to 480 × 10(6) CD19 CAR-positive viable T cells with 90% of
patients receiving the recommended dose of 410 × 10(6) +/- 25%).

 

The most common serious adverse reactions of any Grade (incidence ≥ 2%)
included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS,
fever, bacterial infectious disorders, encephalopathy, fungal infections,
hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and
hypoxia. Nine patients (9%) experienced fatal adverse reactions which included
infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism,
acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients,
five patients who died from infections had pre-existing and ongoing
neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy
treatment and/or AUCATZYL.

 

Please see full Prescribing Information
(http://www.autolus.com/AUCATZYL-USPI/) , including BOXED WARNING and
Medication Guide.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements are statements that are not historical
facts, and in some cases can be identified by terms such as "may," "will,"
"could," "expects," "plans," "anticipates," and "believes." These statements
include, but are not limited to: statements regarding the market and
therapeutic potential of for AUCATZYL for adult r/r B-ALL; Autolus'
development and commercialization of its product candidates; the expected
clinical benefits of AUCATZYL; Autolus' manufacturing, sales and marketing
plans for AUCATZYL, including expectations regarding the timing of commercial
launch in the United States and the ability to reach patients in a timely
manner; the amount and timing of milestone payments under Autolus'
collaboration and license agreements;  and future development plans of
AUCATZYL, including the timing or likelihood of expansion into additional
markets or geographies and related regulatory approvals. Any forward-looking
statements are based on management's current views and assumptions and involve
risks and uncertainties that could cause actual results, performance, or
events to differ materially from those expressed or implied in such
statements. Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation: Autolus'
ability to maintain regulatory approval of AUCATZYL; its ability to execute
its commercialization strategy for AUCATZYL; its ability to develop,
manufacture and commercialize its other product candidates and the timing or
likelihood of expansion of AUCATZYL into additional markets or geographies;
Autolus' ability to establish and expand a commercial infrastructure and to
successfully launch, market and sell AUCATZYL; actions of regulatory agencies,
which may affect the initiation, timing and progress of clinical trials or
future regulatory approval; the labelling for AUCATZYL/obe-cel in any future
indication or patient population, if approved; the potential for payors to
delay, limit or deny coverage for AUCATZYL; Autolus' ability to obtain,
maintain and enforce intellectual property protection for AUCATZYL or any
product candidates it is developing; the results of clinical trials are not
always being predictive of future results; the cost, timing and results of
clinical trials; that many product candidates do not become approved drugs on
a timely or cost effective basis or at all; the ability to enroll patients in
clinical trials; and possible safety and efficacy concerns. For a discussion
of other risks and uncertainties, and other important factors, any of which
could cause Autolus' actual results to differ from those contained in the
forward-looking statements, see the section titled "Risk Factors" in Autolus'
Annual Report on Form 10-K filed with the Securities and Exchange Commission,
or the SEC, on March 21, 2024 as well as discussions of potential risks,
uncertainties, and other important factors in Autolus' subsequent filings with
the Securities and Exchange Commission. All information in this press release
is as of the date of the release, and Autolus undertakes no obligation to
publicly update any forward-looking statement, whether as a result of new
information, future events, or otherwise, except as required by law. You
should, therefore, not rely on these forward-looking statements as
representing Autolus' views as of any date subsequent to the date of this
press release.

 

Contact:

 

Olivia Manser

+44 (0) 7780 471 568

o.manser@autolus.com (mailto:o.manser@autolus.com)

 

Julia Wilson

+44 (0) 7818 430877

j.wilson@autolus.com (mailto:j.wilson@autolus.com)

 

Susan A. Noonan

S.A. Noonan Communications

+1-917-513-5303

susan@sanoonan.com (mailto:susan@sanoonan.com)

 

References

 

1. SEER and EUCAN estimates for US and EU respectively

2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7894150/

3. Aureli A, Marziani B, Venditti A, Sconocchia T, Sconocchia G. Acute
lymphoblastic leukemia immunotherapy treatment: now, next, and beyond. Cancers
(Basel). 2023;15:3346.

4. Dhakal P, Kaur J, Gundabolu K, Bhatt VR. Immunotherapeutic options for
management of relapsed or refractory B-cell acute lymphoblastic leukemia: how
to select newly approved agents? Leuk Lymphoma. 2020;61:7-17.

 

 

11/24 US-AUC-0082

 

 1  SEER and EUCAN estimates for US and EU respectively

 2  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7894150/

(#_ftnref3) *Rate of Overall Complete Remission "At Anytime" includes Complete
Remission (CR) and Complete Remission with incomplete hematologic recovery
(CRi) "At Anytime"

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