- Patient Reported Outcomes (PROs) based on a May 16, 2022 data
cutoff in the QUILT 3.032 trial indicate stability of physical
function and global health in patients who completed PRO
questionnaires and reached month 24 on-study
- Overall, participants with complete responses (CRs) to
combination therapy with the novel interleukin-15 (IL-15)
superagonist N-803 and bacillus Calmette-Guerin (BCG) reported
better physical function than those who did not achieve a CR at
month 6
- Stability of these PROs supports the safety and tolerability of
the potential new treatment combination
- Taken together with the positive durable 71% response and 89.2%
cystectomy avoidance rates in cohort A and a favorable safety
profile at the May 16, 2022 data cutoff, along with the available
PROs, support a favorable risk-benefit ratio for N-803 plus BCG in
this patient population
- 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 April 23, 2024
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy
company, today announced that findings from Patient-Reported
Outcomes (PROs) of participants in the phase 2/3 QUILT 3.032 study
of N-803 plus BCG in BCG-unresponsive non-muscle invasive bladder
cancer (NMIBC) were published by the peer-reviewed journal Urology
Practice. These PROs support the positive interim results from the
study published in NEJM Evidence, wherein 71% of patients in cohort
A with CIS with or without Ta/T1 disease achieved a complete
response.
The published PROs based on a May 16, 2022 data cutoff indicate
that both physical function and global health as self-reported by
QUILT 3.032 participants with BCG-unresponsive NMIBC CIS (cohort A)
or papillary disease (cohort B), remained stable over the 2-year
course of the study for patients who completed the PRO
questionnaires and reached 24 months on-study. In addition, overall
both cohort A and B participants who reached month 24 on-study and
also completed an NMIBC-specific questionnaire focusing on the
challenges of bladder cancer, also reported no decline of their
health or urinary tract-related symptoms while in the study.
Overall, participants who achieved a complete response with the
novel combination therapy reported better physical function by
month six of the study than those who did not achieve a complete
response.
“The self-reported stability of health and physical function
over the course of the study by the participants reflect another
aspect of safety and tolerability of this new combination therapy,”
said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief
Scientific and Medical Officer at ImmunityBio. “Taken together with
the positive response rate in cohort A of over 70%, the persistence
of responses and cystectomy avoidance, these QoL findings suggest a
favorable risk-benefit ratio for this potential new therapeutic
option for patients with BCG-unresponsive bladder cancer.”
The finding of relative stability of global health and physical
function during the course of the study is similar to that reported
by others for BCG monotherapy, suggesting the novel combination is
as tolerable as treatment with BCG alone.
“Many current therapies for bladder cancer slow disease
progression but can cause debilitating side effects,” said
Principal Investigator Karim Chamie, M.D., Associate Professor of
Urology at UCLA. “The data from the QUILT 3.032 Quality of Life
study suggest that many patients not only have a durable response
but also report no decline in physical function, which is very
important for these patients.”
QUILT 3.032 Study Details
The ongoing phase 2/3 open-label multicenter registrational
study QUILT 3.032 (NCT03022825) is evaluating the safety and
efficacy of the investigational interleukin-15 superagonist N-803
(also known as Anktiva® and nogapendekin alfa inbakicept, NAI) in
combination with a standard therapy for NMIBC, bacillus
Calmette-Guerin (BCG), in patients who failed or in whom cancer
returned after BCG monotherapy, and thus were diagnosed as
BCG-unresponsive. The study comprises three cohorts, with cohort A
enrolling patients with carcinoma in situ (CIS) with or without
Ta/T1 disease and cohort B enrolling patients with high grade Ta/T1
papillary disease. Both cohorts A and B received combination N-803
plus BCG therapy. Cohort C patients, with CIS +/- Ta/T1 disease
received N-803 monotherapy.
- The primary end point is 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 (DSS), and overall survival are secondary
end points for cohort A.
- Cohort C was discontinued due to a low response rate with N-803
monotherapy, per study design.
- The FDA has accepted for review ImmunityBio’s resubmission of
its biologics license application (BLA) for N-803 plus BCG for the
treatment of BCG-unresponsive NMIBC CIS with or without Ta or T1
disease, and has set a user fee goal date (PDUFA date) of April 23,
2024.
Bladder cancer is the 10th most-commonly diagnosed cancer, with
approximately 80% of newly diagnosed cases being NMIBC.
Intravesical (directly to the bladder) instillation of BCG after
removal of cancer tissue from the lining of the bladder
(transurethral resection of the bladder tumor; TURBT) is
Standard-of-Care (SoC) for intermediate and high-risk NMIBC
patients, but up to 40% of patients will fail BCG therapy and ~50%
will relapse after an initial response and given a diagnosis of
being BCG-unresponsive. Therapies approved by the FDA for this
indication include pembrolizumab, nadofaragene, combined
gemcitabine and docetaxel, and valrubicin. Radical cystectomy –
surgical removal of the bladder - is also an option for these
patients. QUILT 3.032 is being conducted to address the need for a
safe, effective therapeutic option for BCG-unresponsive NMIBC
patients that provides an opportunity for avoidance of radical
cystectomy.
N-803 is investigational. Safety and efficacy have not been
established by any Health Authority or Agency, including the
FDA.
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. ImmunityBio is applying its
science and platforms to treating cancers, including the
development of potential cancer vaccines, as well as developing
immunotherapies and cell therapies that ImmunityBio believes
sharply reduce or eliminates 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
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 ongoing
clinical trials and potential implications therefrom, potential
benefits to patients, potential treatment outcomes for patients,
the regulatory review process and timing thereof, market and
prevalence data, and ImmunityBio’s investigational agents as
compared to other existing and potential treatment options, among
others. While ImmunityBio believes the BLA resubmission addresses
the issues identified in the FDA’s complete response letter, there
is no guarantee that the FDA will ultimately agree that such issues
have been successfully addressed and resolved. 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 the regulatory review process, (ii) whether or not
the FDA will ultimately determine that the BLA resubmission and
related actions successfully addresses and resolves the issues
identified in the FDA’s complete response letter, (iii)
uncertainties regarding the timeline of FDA review of the
resubmitted BLA, (iv) any inability to successfully work with the
FDA to find a satisfactory solution to address any concerns in a
timely manner or at all during the review process for the BLA,
including any inability to provide the FDA with data, analysis or
other information sufficient to support an approval of the BLA, (v)
the ability of ImmunityBio and its third party contract
manufacturing organizations to adequately address the issues raised
in the CRL, (vi) any potential facility re-inspections that may be
required regarding ImmunityBio’s third party contract manufacturing
organizations or otherwise and results therefrom, (vii) whether the
FDA accepts the data and results as included in the BLA
resubmission at levels consistent with the published results, or at
all, (viii) 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 and
planned regulatory submissions, (xi) ImmunityBio’s ability to
retain and hire key personnel, (ix) ImmunityBio’s ability to obtain
additional financing to fund its operations and complete the
development and commercialization of its various product
candidates, (x) ImmunityBio’s ability to successfully commercialize
its product candidates and uncertainties around regulatory reviews
and approvals, (xi) ImmunityBio’s ability to scale its
manufacturing and commercial supply operations for its product
candidates and future approved products, and (xii) 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 1, 2023 and the Company’s
Form 10-Q filed with the SEC on November 9, 2023, 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/20240205300717/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@Salutem.com
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