- Designated an FDA Breakthrough Therapy, the novel immunotherapy
ANKTIVA activates the body’s natural killer (NK) and killer T-cell
immune system to attack tumor cells
- Therapy stimulates memory T cells, leading to long duration of
complete response exceeding 47 months and ongoing to date, with a
median duration of response yet to be determined
- The percentage of patients with durable responses at 12 and 24
months exceeded the benchmark for magnitude of clinically
meaningful results established by experts at the International
Bladder Cancer Group (IBCG)
- ANKTIVA in combination with BCG is approved for maintenance
therapy for up to 37 months with tolerable side effects ranging
from 0% to 3% Grade 3/4 adverse events
- ANKTIVA is expected to be available in the U.S. by mid-May
2024
- Conference call and webcast are expected to be held April 26 at
11:00 am EDT
ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company,
today announced that the U.S. Food and Drug Administration (FDA)
has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln)
plus Bacillus Calmette-Guérin (BCG) for the treatment of patients
with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)
with carcinoma in situ (CIS), with or without papillary tumors.
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ImmunityBio’s ANKTIVA is approved for
non-muscle invasive bladder cancer (Photo: Business Wire)
“The FDA’s approval of ANKTIVA marks our launch of a
next-generation immunotherapy beyond checkpoint inhibitors,” said
Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief
Scientific and Medical Officer at ImmunityBio. “ANKTIVA not only
proliferates and activates the patient’s own NK cells and CD8+
killer T cells, but also activates CD4+ T helper cells, thus
enhancing the proliferation of memory killer T cells. This novel
mechanism of action, which mimics the biology of the dendritic
cell, begins the evolution of immunotherapy beyond T cells alone.
The combination of the proliferation of key cancer-killing immune
cells, together with the activation of T cells with memory, results
in durable complete responses. The ‘triangle offense’ of tumor cell
killing by the body’s immune system with long-term memory is the
foundation of our efforts to develop a therapeutic cancer vaccine
across multiple tumor types, regardless of the site of origin.”
ANKTIVA, a first-in-class IL-15 agonist immunotherapy for NMIBC,
received Breakthrough Therapy Designation and approval from the FDA
based on the safety and efficacy outcome of complete responses (CR)
and duration of complete response (DOR). The 77 evaluable patients
in this single-arm, multicenter trial received ANKTIVA with BCG
maintenance therapy for up to 37 months. The tumor status was
assessed with cystoscopy and urine cytology and will continue for
up to five years after each patient began their participation in
the trial.
The CR rate for the 77 evaluable patients was 62% with the upper
end of the confidence interval being 73%. The duration of complete
response as of the November 2023 cut-off was more than 47 months
and is ongoing to date. These prolonged duration of complete
response results beyond 24 months with ANKTIVA and BCG exceed the
benchmark for the magnitude of meaningful clinical results
suggested by a panel of experts at the IBCG.
“We are pleased that treatment with ANKTIVA now exceeds the
clinically meaningful benchmarks established by the IBCG in 2016
for durable complete response,” said Roger Buckley, with the IBCG.
“We look forward to the global availability of ANKTIVA to
potentially reduce the need for cystectomy in many patients
worldwide with NMIBC.”
The duration of response is ongoing, so the final median
duration of response has yet to be determined. Fifty-eight percent
(58%) of patients with CR had a DOR ≥ 12 months and 40% had a DOR ≥
24 months.
“The long duration of complete response ranging over 47 months
is a game changer for NMIBC patients and provides further clinical
evidence of ANKTIVA’s effectiveness for patients who historically
have faced high rates of recurrence and significantly diminished
quality of life due to radical surgeries,” said Karim Chamie, M.D.,
Associate Professor of Urology at UCLA and principal investigator
for the QUILT 3.032 study. “With this approval, ANKTIVA could
represent a new standard of care for patients with NMIBC and has
the potential to change the way we treat bladder cancer.”
ANKTIVA is expected to be available in the U.S. by mid-May
2024.
New Hope for Patients
Bladder cancer is the 10th most commonly-diagnosed cancer
globally,1 and in the U.S., the American Cancer Society estimates
there will be 83,190 new cases and 16,840 deaths from bladder
cancer in 2024.2 At the time of diagnosis, about 80% of cases are
non-muscle invasive bladder cancer (NMIBC), wherein the cancer is
found only on the inner layer of the bladder wall.3 The standard
therapy for NMIBC is intravesical instillation (delivery to the
bladder via a catheter) of bacillus Calmette-Guerin (BCG).4,5 BCG
is a benign bacteria that induces an immune response in the bladder
in proximity to the cancer cells, leading to clearance of the
cancer in many patients. In ~30-40% of patients, however, BCG will
fail, and in ~50% that initially respond, cancer will recur.6
"A new immunotherapy that builds upon our knowledge and
experience with BCG as an immune stimulant is exciting to see,”
said Ashish Kamat, M.D., MBBS, an Endowed Professor of Urologic
Oncology and Cancer Research at University of Texas MD Anderson
Cancer Center. “While patients have had limited options in the past
after failure of BCG, nogapendekin alfa inbakicept-pmln, with its
reported safety and efficacy, now offers them yet another choice in
their quest to avoid a radical cystectomy. This is a big win for
NMIBC patients everywhere.”
With the approval of ANKTIVA in combination with BCG, NMIBC
patients who would otherwise face highly invasive surgery with
life-long consequences have an important new therapeutic option
with a long-term durable complete response.
“ANKTIVA enhances natural killer cell recruitment as well as T
cell stimulation. By doing this and stimulating the innate immune
memory response, we get an improved ability to kill tumor cells,”
said Sam S. Chang, M.D., Professor of Urology and Chief Surgical
Officer of the Vanderbilt Ingram Cancer Center, and a principal
investigator for the QUILT 3.032 study. “It’s a potent and exciting
combination.”
“NMIBC has a high rate of recurrence that sometimes results in
major surgery to remove the bladder to prevent further disease
progression,” said Andrea Maddox-Smith, CEO of the Bladder Cancer
Advocacy Network (BCAN). “The addition of ANKTIVA to BCG gives
NMIBC patients and their physicians a much-needed, new option to
effectively treat the disease and offers an important non-surgical
alternative to a cystectomy.”
ANKTIVA was well-tolerated with adverse events consistent with
that of BCG alone. Studies of ANKTIVA in BCG-unresponsive and
BCG-naive patients are ongoing. Reports of 82 subjects of high risk
CIS NMIBC were reported in NEJM Evidence and previously
presented.
The co-authors of an expert commentary on the published findings
for ANKTIVA plus BCG in European Urology—Drs. Peter Black, Jonathan
Suderman, and Marie-Pier St-Laurent—from the University of British
Columbia, Vancouver, stated, “This appears to be a major advance in
disease control in this patient population, especially when the low
rate of serious adverse events is considered.” They further stated,
“One could make the argument that NAI [ANKTIVA] should now become
the standard of care given its more rigorous clinical trial
data.”
Further updates on the ongoing analysis of QUILT-3.032
(NCT03022825) will be presented by Dr. Soon-Shiong at the upcoming
American Urological Association’s annual conference on May 3,
2024.
“Today’s approval of ANKTIVA for patients with NMIBC marks an
important milestone in our quest to develop cancer vaccines, and
preventative vaccines for patients with genetic predisposition to
developing cancer such as in Lynch syndrome,” said Soon-Shiong. “We
believe that by orchestrating the innate and adaptive immune system
and driving long-term complete remission, ANKTIVA has the potential
to play a key role as the immunotherapy beyond checkpoints in
multiple tumor types in the years to come.”
ANKTIVA has been studied in more than 700 patients in multiple
Phase 1 and 2 trials in both liquid and solid tumors. In addition
to trials in NMIBC, it is currently being studied in trials for
non-small-cell lung cancer, colorectal cancer, non-Hodgkin’s
lymphoma, glioblastoma, solid tumors, and HIV. Future studies are
planned for platinum-resistant ovarian cancer and acute myeloid
leukemia.
How ANKTIVA (N-803) Works
The cytokine interleukin-15 (IL-15) plays a crucial role in the
immune system by affecting the development, maintenance, and
function of key immune cells—NK and CD8+ killer T cells—that are
involved in killing cancer cells.
ANKTIVA is a novel IL-15 superagonist complex consisting of an
IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which
binds with high affinity to IL-15 receptors on NK, CD4, and CD8 T
cells. This mimics the natural biological properties of dendritic
cells, and drives the generation of memory killer T cells that have
specifically been trained to recognize the cancer cells, resulting
in activation and proliferation of these killing cells with durable
complete response. ANKTIVA has improved pharmacokinetic properties,
longer persistence in lymphoid tissues, and enhanced anti-tumor
activity compared to native, non-complexed IL-15 in vivo.
Selected Safety Information for ANKTIVA (N-803)
The most common (≥15%) adverse reactions, including laboratory
test abnormalities, are increased creatinine, dysuria, hematuria,
urinary frequency, micturition urgency, urinary tract infection,
increased potassium, musculoskeletal pain, chills, and pyrexia.
Patient Assistance Program
ImmunityBio is committed to helping patients access ANKTIVA and
will be offering services to overcome access barriers.
ImmunityBio’s Patient Assistance Program will be operational in mid
May. This program is designed to help those in need, ensuring
access to ImmunityBio’s innovative treatment. More information for
patients and healthcare professionals will be available on
Anktiva.com.
Conference Call and Webcast Information
ImmunityBio management will discuss FDA approval of ANKTIVA in
combination with BCG for the treatment of BCG-unresponsive NMIBC
via a conference call and webcast on Fri., April 26, 2024 at 11 am
EDT. The conference call registration details will be available in
the IR section of the ImmunityBio website.
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company
developing next-generation therapies and vaccines that bolster the
natural immune system to defeat cancers and infectious diseases.
The company’s range of immunotherapy and cell therapy platforms,
alone and together, act to drive and sustain an immune response
with the goal of creating durable and safe protection against
disease. We are applying our science and platforms to treating
cancers, including the development of potential cancer vaccines, as
well as developing immunotherapies and cell therapies that we
believe sharply reduce or eliminate the need for standard high-dose
chemotherapy. These platforms and their associated product
candidates are designed to be more effective, accessible, and
easily administered than current standards of care in oncology and
infectious diseases.
For more information, please visit: www.immunitybio.com
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, such as statements regarding data and results from clinical
trials and potential implications therefrom, commercialization
plans and timelines, including product availability, potential
regulatory pathways and approvals including outside of the United
States, the regulatory review process and timing thereof, market
and prevalence data, potential benefits to patients, potential
treatment outcomes for patients, the described mechanism of action
and results and contributions therefrom, information regarding
potential benefit to patients, information regarding ongoing
pre-clinical studies and clinical trials, potential future uses and
applications of ANKTIVA and use in cancer vaccines, methods,
conference call and webcast timing, and ImmunityBio’s approved
product and investigational agents as compared to existing
treatment options, among others. Statements in this press release
that are not statements of historical fact are considered
forward-looking statements, which are usually identified by the use
of words such as “anticipates,” “believes,” “continues,” “goal,”
“could,” “estimates,” “scheduled,” “expects,” “intends,” “may,”
“plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,”
“should,” “will,” “strategy,” and variations of such words or
similar expressions. Statements of past performance, efforts, or
results of our preclinical and clinical trials, about which
inferences or assumptions may be made, can also be forward-looking
statements and are not indicative of future performance or results.
Forward-looking statements are neither forecasts, promises nor
guarantees, and are based on the current beliefs of ImmunityBio’s
management as well as assumptions made by and information currently
available to ImmunityBio. Such information may be limited or
incomplete, and ImmunityBio’s statements should not be read to
indicate that it has conducted a thorough inquiry into, or review
of, all potentially available relevant information. Such statements
reflect the current views of ImmunityBio with respect to future
events and are subject to known and unknown risks, including
business, regulatory, economic and competitive risks,
uncertainties, contingencies and assumptions about ImmunityBio,
including, without limitation, (i) the risks and uncertainties
associated with commercial launch execution, success and timing,
(ii) risks and uncertainties related to the regulatory submission
and review process including without limitation outside of the
United States, (iii) the ability of ImmunityBio to continue its
planned preclinical and clinical development of its development
programs through itself and/or its investigators, and the timing
and success of any such continued preclinical and clinical
development, patient enrollment and planned regulatory submissions,
(iv) ImmunityBio’s ability to retain and hire key personnel, (v)
ImmunityBio’s ability to obtain additional financing to fund its
operations and complete the development and commercialization of
its various product candidates, (vi) potential product shortages or
manufacturing disruptions that may impact the availability and
timing of product, (vii) ImmunityBio’s ability to successfully
commercialize its product candidates and uncertainties around
regulatory reviews and approvals, (viii) ImmunityBio’s ability to
scale its manufacturing and commercial supply operations for its
product candidates and future approved products, and (ix)
ImmunityBio’s ability to obtain, maintain, protect and enforce
patent protection and other proprietary rights for its product
candidates and technologies. More details about these and other
risks that may impact ImmunityBio’s business are described under
the heading “Risk Factors” in the Company’s Form 10-K filed with
the U.S. Securities and Exchange Commission (“SEC”) on March 19,
2024 and in subsequent filings made by ImmunityBio with the SEC,
which are available on the SEC’s website at www.sec.gov.
ImmunityBio cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date hereof.
ImmunityBio does not undertake any duty to update any
forward-looking statement or other information in this press
release, except to the extent required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240422820209/en/
Investors Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc. +1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media Greg Tenor Salutem +1 717-919-6794
Gregory.Tenor@Salutemcomms.com
ImmunityBio (NASDAQ:IBRX)
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