- Expanded clinical trial program with ADSTILADRIN starts
up in the United States
- Current clinical trial program of five multi-year studies to
evaluate ADSTILADRIN demonstrate Ferring’s commitment to improve
outcomes for patients across the spectrum of urothelial
cancers
- Research will enlarge the body of evidence for ADSTILADRIN, the
first and only FDA-approved intravesical non-replicating gene
therapy for NMIBC
Ferring Pharmaceuticals today announced start up of new studies
in the United States (U.S.) for three new ADSTILADRIN in
BLadder cancEr (ABLE) clinical trials in patients
with non-muscle invasive bladder cancer (NMIBC) with plans to
expand select clinical trials outside of the U.S. later this year.
ADSTILADRIN was approved by the U.S. Food and Drug Administration
(FDA) in December 2022 for adult patients with high-risk Bacillus
Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ
(CIS) with or without papillary tumors.
“ADSTILADRIN is the foundation of Ferring's leadership mission
in the uro-oncology therapeutic category and our ambition is for it
to become the new standard of care and the backbone therapy for
patients across the NMIBC disease spectrum,” said Bipin Dalmia,
Senior Vice President, Global Head, Uro-Oncology Franchise, Ferring
Pharmaceuticals. “Embarking on a broad research and geographic
expansion program is yet another demonstration of our commitment to
the uro-oncology community, together with our significant
manufacturing investments that recently enabled full availability
of ADSTILADRIN to every appropriate U.S. patient who needs it.”
The addition of three new ABLE clinical trials to the existing
multi-year ADSTILADRIN studies program will expand the body of
evidence for the intravesical non-replicating gene therapy:
- ABLE-22: A Phase 2, randomized, multi-center, open label
clinical study to evaluate the safety and efficacy of ADSTILADRIN
alone or in combination with chemotherapy (gemcitabine and
docetaxel) or immunotherapy (pembrolizumab) in adult patients with
high-grade BCG-unresponsive NMIBC.
- ABLE-32: A Phase 3b randomized, controlled clinical
study to evaluate the safety and efficacy of ADSTILADRIN versus
observation in patients with intermediate-risk NMIBC.
- ABLE-42: A Phase 4, multi-center, open-label clinical
study to evaluate the efficacy of retreatment with ADSTILADRIN in
previously-treated patients with high-grade BCG-unresponsive NMIBC
with CIS with or without papillary tumors who had not responded to
the product at the first three-month assessment.
“ADSTILADRIN is an established monotherapy treatment option for
patients with BCG-unresponsive NMIBC disease, an area where
patients’ treatment options have been severely limited for
decades,” said Pierre-Yves Berclaz, M.D., Ph.D., Executive Vice
President and Chief Science and Medical Officer, Ferring
Pharmaceuticals. “These new trials underscore Ferring's commitment
to create solutions for patients by enlarging the body of evidence
for this novel nonreplicating gene therapy.”
The ADSTILADRIN clinical trial program includes two additional
studies, the first being ABLE–41, a U.S. Real-World Evidence (RWE)
Study announced in September 2023 and the second being a bridging
study in Japan. The ABLE-22, ABLE-32 and ABLE-42 clinical trials
announced today are yet another milestone for this comprehensive
research program.
Additional ongoing studies in the ADSTILADRIN clinical trial
program include:
- ABLE-41 (NCT06026332): An ongoing, non-interventional
RWE study following NMIBC patients aged 18 years or older with
high-risk, BCG-unresponsive NMIBC who are being treated with
ADSTILADRIN in a clinical setting and had not previously received
this therapy in a clinical trial. The study is exploring early
utilization, experiences, and outcomes of ADSTILADRIN in the
routine care setting in these patients. The first patient was
enrolled in September 2023.
- Japan Phase 3B Study (000381): Single arm bridging study
of high grade, BCG-unresponsive NMIBC patients.
Healthcare providers in the U.S. can learn more about the
ADSTILADRIN clinical trial program by calling 1-888-FERRING
(888-337-7464) and selecting option number one or emailing
medqueriesus@ferring.com.
About ADSTILADRIN
ADSTILADRIN® (nadofaragene firadenovec-vncg) is the first and
only FDA-approved intravesical non-replicating gene-therapy for the
treatment of adult patients with high-risk Bacillus Calmette-Guérin
(BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with
carcinoma in situ (CIS) with or without papillary tumors. It is a
non-replicating adenovirus vector-based therapy containing the gene
interferon alfa-2b, administered locally as a monotherapy by
catheter directly into the bladder once every three months. The
vector enters the cells of the bladder wall, releasing the active
gene and causing the bladder’s cell walls to secrete high
quantities of interferon alfa-2b protein, a naturally-occurring
protein the body uses to fight cancer. This approach essentially
turns the bladder wall cells into interferon microfactories,
enhancing the body’s own natural defenses against the cancer.
ADSTILADRIN has been studied in a clinical trial program that
includes 157 patients with high-grade, BCG-unresponsive NMIBC who
had been treated with adequate BCG previously and did not see
benefit from additional BCG treatment (full inclusion criteria
published on clinicaltrials.gov: NCT02773849).1
About Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC is a form of bladder cancer which is present in the
superficial layer of the bladder and has not invaded deeper into
the bladder or spread to other parts of the body.2 In the United
States, bladder cancer is the seventh most common cancer, fourth
among men3-4, and it is estimated that there will be approximately
83,190 new cases of bladder cancer in the U.S. in 2024.5
Historically, 75% of bladder cancer presents as NMIBC.6 In patients
with high-risk NMIBC, intravesical BCG remains the first-line
standard-of-care. However, more than 50% of patients who receive
initial treatment with BCG will experience disease recurrence and
progression within one year, with many developing BCG-unresponsive
disease.5 Current treatment options for BCG-unresponsive patients
are very limited, and National Comprehensive Cancer Network (NCCN)
guidelines recommend cystectomy (partial or complete removal of the
bladder).7
INDICATION
ADSTILADRIN is a non-replicating adenoviral vector-based gene
therapy indicated for the treatment of adult patients with
high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle
invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with
or without papillary tumors.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: ADSTILADRIN is contraindicated in
patients with prior hypersensitivity reactions to interferon alfa
or to any component of the product.
WARNINGS AND PRECAUTIONS:
- Risk with delayed cystectomy: Delaying cystectomy in patients
with BCG-unresponsive CIS could lead to development of muscle
invasive or metastatic bladder cancer, which can be lethal. If
patients with CIS do not have a complete response to treatment
after 3 months or if CIS recurs, consider cystectomy.
- Risk of disseminated adenovirus infection: Persons who are
immunocompromised or immunodeficient may be at risk for
disseminated infection from ADSTILADRIN due to low levels of
replication-competent adenovirus. Avoid ADSTILADRIN exposure to
immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by
intravesical instillation only. ADSTILADRIN is not for intravenous
use, topical use, or oral administration.
USE IN SPECIFIC POPULATIONS: Advise females of
reproductive potential to use effective contraception during
ADSTILADRIN treatment and for 6 months after the last dose. Advise
male patients with female partners of reproductive potential to use
effective contraception during ADSTILADRIN treatment and for 3
months after the last dose.
ADVERSE REACTIONS: The most common (>10%) adverse
reactions, including laboratory abnormalities (>15%), were
glucose increased, instillation site discharge, triglycerides
increased, fatigue, bladder spasm, micturition (urination urgency),
creatinine increased, hematuria (blood in urine), phosphate
decreased, chills, pyrexia (fever), and dysuria (painful
urination).
You are encouraged to report negative side effects of
prescription drugs to FDA. Visit www.FDA.gov/medwatch
or call 1-800-332-1088. You may also contact Ferring
Pharmaceuticals at 1-888-FERRING.
Please click to see the full Prescribing Information.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately-owned, research-driven,
specialty biopharmaceutical group committed to building families
and helping people live better lives. In the United States, Ferring
is a leader in reproductive medicine and maternal health, and in
areas of gastroenterology and orthopaedics. We are at the forefront
of innovation in microbiome-based therapeutics and uro-oncology
intravesical gene therapy. Our company was founded in 1950 and is
headquartered in Saint-Prex, Switzerland. Ferring employs more than
7,000 people worldwide and markets its medicines in over 100
countries. Ferring USA is based in Parsippany, New Jersey, and
employs more than 900 employees.
For more information, please visit www.ferringusa.com, call
1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and
X (Twitter).
References:
- ADSTILADRIN in Patients With High Grade, Bacillus
Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder
Cancer (NMIBC). Gov Identifier: NCT02773849.
https://clinicaltrials.gov/ct2/show/NCT02773849.
- Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical
nadofaragene firadenovec gene therapy for BCG-unresponsive
non-muscle-invasive bladder cancer: a single-arm, open-label,
repeat-dose clinical trial. Lancet Oncol 2021; 22: 107–17.
- Bladder Cancer Advocacy Network. Bladder Cancer Advocacy
Network Responds to American Cancer Society’s 2024 Projections.
Bladder Cancer Advocacy Network Responds to American Cancer
Society's 2024 Projections – Bladder Cancer Advocacy Network
(bcan.org), page last accessed: March 2024.
- American Cancer Society. Cancer Facts & Figures 2024
Report. Cancer Facts & Figures 2024, page last accessed: March
2024
- American Cancer Society. Cancer Facts & Figures 2024.
Atlanta: American Cancer Society; 2024.
https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html.
Accessed April, 2024.
- Babjuk M, Burger M, Capoun O, European Association of Urology
Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022
Jan;81(1):75-94.
- National Comprehensive Cancer Network. Bladder Cancer (Version
1.2024). www.nccn.org/professionals/physicians_gls/pdf/bladder.pdf.
Accessed March 7, 2024.
More information is available at the following:
- Health Care Providers: If you are interested in ordering
ADSTILADRIN, please visit www.ADSTILADRINHCP.com to either Request
a Rep or follow the product ordering instructions outlined on the
product website.
- Patients and Consumers: For more information about
ADSTILADRIN, please visit ADSTILADRIN.com or call 1-888-FERRING
(888-337-7464) and select option number one.
- Media: Members of the press can contact Carol
Ready, Director, Brand Communications by phone at (973)
765-7307, or email at carol.ready@ferring.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240415649389/en/
Carol Ready Director, Brand Communications (973) 765-7307
carol.ready@ferring.com