- Primary endpoint met in high-risk carcinoma in situ (CIS)
cohort with 71% complete response rate (CR) with a median duration
of response of 26.6 months, a 53% CR rate at 24 months and a safety
profile comparable to BCG alone
- This novel IL-15 superagonist N-803 – referred to as
nogpendekin alfa inbakicept (NAI) in the manuscript - acts
synergistically with BCG with a 90% probability of avoiding
cystectomy over 24 months in responders
- Primary endpoint also met in papillary non-muscle invasive
bladder cancer (NMIBC) cohort with 55% remaining disease free at 12
months
- The Food and Drug Administration (FDA) is currently reviewing
the Biologics License Application (BLA) for N-803 plus BCG for the
treatment of NMIBC CIS with a Prescription Drug User Fee Act
(PDUFA) date of May 23, 2023
NEJM Evidence has published results from the QUILT 3.032 trial
studying N-803 plus BCG in adults with NMIBC CIS with or without
Ta/T1 papillary disease. These positive data form the basis of
ImmunityBio’s BLA for BCG-unresponsive NMIBC CIS, which the FDA
accepted for review in July 2022.
The published results demonstrate that in patients with
BCG-unresponsive NMIBC CIS and papillary disease, BCG plus N-803
(referred to as NAI) CRs were achieved with a persistence of effect
with 90% probability of avoiding cystectomies in responders, a
life-changing procedure of removing the bladder, and 100% bladder
cancer-specific survival at 24 months. This investigational therapy
represents an important clinical benefit addressing an unmet need
of avoiding a cystectomy in this high-risk bladder cancer
population.
“The peer review and publication of data in NEJM Evidence
highlights the significance of the positive results of the QUILT
3.032 trial in patients with BCG-unresponsive NMIBC,” said Patrick
Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific
and Medical Officer at ImmunityBio. “We’re targeting the 10th most
commonly diagnosed cancer and the one with the highest lifetime
treatment costs per patient as a result of the prolonged course of
the disease and the need for repeated surgical and treatment
intervention. These data further our understanding of N-803’s
unique role in potentially boosting the proliferation of natural
killer and T cells while synergistically enhancing BCG
efficacy.”
Patients with intermediate or high-risk NMIBC typically receive
a treatment of transurethral resection of the bladder tumor (TURBT)
followed by BCG intravesical instillation. However, cancer will
recur in 30% to 40% of patients with NMIBC despite adequate
treatment with BCG. Moreover, even among those in whom a complete
response is achieved with BCG, up to 50% see their cancer
return.
Treatment options for BCG-unresponsive NMIBC patients are
limited. Pembrolizumab was approved by the FDA for this indication
in 2020, based on findings from the KEYNOTE-057 study in which the
CR rate in NMIBC CIS patients was 41% with a median response
duration of 16.2 months. The combination of N-803 plus BCG produced
both a higher CR rate and more durable responses.
In patients who received intravesical N-803 plus BCG (cohort A),
a CR was achieved in 58 (71%) of 82 patients (95% confidence
interval [CI]=59.6 to 80.3; median follow-up, 23.9 months), with a
median duration of 26.6 months 95% CI 59.9 months to [upper bound
not reached]). At 24 months in patients with CR, the
Kaplan–Meier–estimated probability of avoiding cystectomy and of
disease-specific survival was 89.2% and 100%, respectively.
In patients with BCG-unresponsive high-grade Ta/T1 papillary
NMIBC who received N-803 plus BCG (cohort B), the
Kaplan–Meier–estimated disease-free survival (DFS) rate was 55.4%
(95% CI=42.0% to 66.8%) at 12 months, with median DFS of 19.3
months (95% CI=7.4 months to [upper bound not reached]).
Most adverse events for patients receiving BCG plus NAI were
grade 1 to 2 (86%) and comparable to adverse events associated with
BCG alone.
About the QUILT 3.032 Trial
In this phase 2/3, open-label, multicenter study, patients with
BCG-unresponsive bladder carcinoma in situ (CIS) with or without
Ta/T1 papillary disease were treated with intravesical N-803 plus
BCG (cohort A) or N-803 alone (cohort C). Patients with
BCG-unresponsive high-grade Ta/T1 papillary NMIBC also received
N-803 plus BCG (cohort B). The primary end point was the incidence
of CR at the 3- or 6-month assessment visit for cohorts A and C,
and the disease-free survival (DFS) rate at 12 months for cohort B.
Durability, cystectomy avoidance, progression-free survival,
disease-specific survival, and overall survival were secondary end
points for cohort A.
The results of this phase 2/3 study are currently being reviewed
by the FDA, and a decision from the FDA regarding approval for use
of the biologics N-803 plus BCG in adults with BCG-unresponsive
NMIBC CIS is expected on May 23, 2023.
ImmunityBio’s IL-15 superagonist N-803
The cytokine interleukin-15 (IL-15) plays a crucial role in the
immune system by affecting the development, maintenance, and
function of the natural killer (NK) and T cells. N-803 (generic
name nogapendekin alfa inbakicept or NAI) is a novel IL-15
superagonist complex consisting of an IL-15 mutant (IL-15N72D)
bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism
of action is direct specific stimulation of CD8+ T cells and NK
cells through beta gamma T-cell receptor binding (not alpha) while
avoiding T-reg stimulation. N-803 has improved pharmacokinetic
properties, longer persistence in lymphoid tissues and enhanced
anti-tumor activity compared to native, non-complexed IL-15 in
vivo.
N-803 has been studied in more than 700 patients in multiple
phase 1 and 2 trials in both liquid and solid tumors. In addition
to the study in NMIBC, it is currently being studied in trials for
pancreatic cancer, non-small-cell lung cancer, non-Hodgkin’s
lymphoma, and HIV.
N-803 has received both Breakthrough Therapy and Fast Track
designations by the FDA for the treatment of BCG-unresponsive NMIBC
CIS, as well as Fast Track designation for BCG-unresponsive NMIBC
papillary and BCG-naïve NMIBC CIS. However, it is important to note
such designations may not lead to a faster development process or
regulatory review and may not increase the likelihood that a
product candidate will receive approval. Seminal patents covering
intravesical administration of BCG and N-803 were issued (US
11,173,191 B2 and US 9,925,247 B2) providing term coverage until
2035.
About ImmunityBio
ImmunityBio is a vertically integrated, clinical-stage
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. 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.
ImmunityBio’s clinical pipeline consists of 27 clinical
trials—18 of which are in phase 2 or 3 development—across 13
indications in liquid and solid tumors (including bladder,
pancreatic, and lung cancers) and infectious diseases (including
SARS-CoV-2 and HIV). N-803 (Anktiva™), ImmunityBio’s lead cytokine
fusion protein, is a novel IL-15 superagonist complex and has
received Breakthrough Therapy and Fast Track Designations from the
U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS
non-muscle invasive bladder cancer (NMIBC).
The company has established GMP manufacturing capacity at scale
with cutting-edge cell therapy manufacturing expertise and
ready-to-scale facilities, as well as extensive and seasoned
R&D, clinical trial, and regulatory operations, and development
teams. 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 from the clinical trials
for certain of ImmunityBio’s product candidates, the regulatory
review process and timing thereof, potential implications to be
drawn from the QUILT 3.032 and other studies, whether the described
mechanism of action contributes to response rate and duration,
potential commercialization of ImmunityBio’s product candidates,
ImmunityBio’s product candidates as compared to existing treatment
options, intellectual property protection, and clinical trial
advancements and data, 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,” “could,”
“estimates,” “expects,” “intends,” “may,” “plans,” “potential,”
“predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” 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) whether the
FDA will approve ImmunityBio’s filed BLA and the risks and
uncertainties associated with the regulatory approval process and
timing thereof, (ii) the ability of ImmunityBio to continue its
planned preclinical and clinical development of its development
programs, and the timing and success of any such continued
preclinical and clinical development and planned regulatory
submissions, (iii) ImmunityBio’s ability to retain and hire key
personnel, (iv) ImmunityBio’s ability to obtain additional
financing to fund its operations and complete the development and
commercialization of its various product candidates, (v)
ImmunityBio’s ability to successfully commercialize its product
candidates and uncertainties around regulatory reviews and
approvals, (vi) ImmunityBio’s ability to scale its manufacturing
and commercial supply operations for its product candidates and
future approved products, (vii) ImmunityBio’s ability to obtain,
maintain, protect and enforce patent protection and other
proprietary rights for its product candidates and technologies, and
(viii) the unknown future impact of the COVID-19 pandemic on
certain clinical trials or their milestones and/or ImmunityBio’s
business operations or operating expenses. 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 1, 2022 and the Company’s Form 10-Q filed with the SEC on
May 10, 2022, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221110006024/en/
Investors Sarah Singleton ImmunityBio, Inc. 844-696-5235,
Option 5 Sarah.Singleton@immunitybio.com
Media Katie Dodge Salutem 978-360-3151
Katie.Dodge@salutemcomms.com
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