- Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only
inhibitor approved for the treatment of r/r PTCL based on results
from the multinational pivotal JACKPOT8B study.
- Golidocitinib monotherapy demonstrated superior and durable
clinical benefits and a favorable safety profile in r/r PTCL
patients, compared with existing treatment options.
SHANGHAI, June 19,
2024 /PRNewswire/ -- Dizal (SSE:688192), a
biopharmaceutical company committed to developing novel medicines
for the treatment of cancer and immunological diseases, today
announced that the National Medical Products Administration of
China has approved golidocitinib
for the treatment of adult patients with relapsed or refractory
(r/r) peripheral T-Cell lymphoma (PTCL) whose disease has
progressed on or were refractory to at least 1 prior systemic
therapy. To date, golidocitinib is the first and only approved
Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients
globally.
PTCL is a heterogeneous group of aggressive T-cell/natural
killer (NK) cell non-Hodgkin lymphomas (NHL). Patients with PTCL
face an extremely high risk of disease relapse even if they
achieved tumor remission following first-line conventional
therapy. The outcome for relapsed or refractory patients is
extremely poor, with a 3-year survival rate of 23% and a median
overall survival (mos.) of 5.8 months. Although couple of drugs
have been granted conditional approval by regulatory agencies in
the relapsed or refractory setting, their single agent activities
have been modest, with objective response rates (ORRs) lower than
30%.
Golidocitinib was approved based on findings from JACKPOT8 Part
B (JACKPOT8B) study, the multinational pivotal study to evaluate
the efficacy and safety of golidocitinib in r/r PTCL as a
monotherapy. The primary endpoint was the objective response
rate (ORR), assessed by an independent review committee (IRC). Full
analysis of the study was simultaneously published in The Lancet
Oncology and presented in oral session at the 65th American
Society of Hematology Annual Meeting and Exposition.
In JACKPOT8B study, golidocitinib demonstrated superior and
durable antitumor efficacy and a favorable safety profile in r/r
PTCL patients, compared with existing treatment options. At the
data cut-off date August 31, 2023,
the ORR was 44.3% including a complete response (CR) rate of 23.9%
per IRC. Tumor responses were observed across various PTCL
subtypes. The median duration of response (mDoR) was 20.7 months
and 53.8% of patients were still responding.
"Golidocitinib features novel mechanism and unique molecular
design, positioning it as the first oral JAK1 only inhibitor for
the treatment of r/r PTCL. Multiple studies have clearly
demonstrated its favorable pharmacokinetic properties and
significant clinical benefit," said Jun
Zhu, MD, PhD at the Department of Lymphoma, Peking
University Cancer Hospital and Institute, the leading principal
investigator of the JACKPOT8B study, "Golidocitinib achieved an ORR
of 44.3% and a DoR of 20.7 months in r/r PTCL. It's approval and
market launch provide a much needed option for doctors to treat
PTCL patients."
Dizal was the first to identify and validate targeting the
JAK/STAT pathway as a promising therapeutic approach for PTCL,
leading to the development of golidocitinib as the world's first
JAK1 only inhibitor. With > 200 to 400-fold selectivity over
other JAK family members and ideal pharmacokinetic properties,
golidocitinib exerts potent antitumor efficacy with a favorable
safety profile.
"We are thrilled to bring golidocitinib, the world's first JAK1
only inhibitor, to patients in China, marking the second approved innovative
drug from Dizal," said Xiaolin
Zhang, PhD, CEO of Dizal. "Golidocitinib yields good
antitumor efficacy across different subtypes of PTCL, which
differentiate golidocitinib from other targeted therapies. At
Dizal, we aspire to discover and develop first-in-class and
groundbreaking new medicines to address unmet medical needs around
the world. With the US FDA Fast Track designation, we are
expediting global development of golidocitinib to bring this
exciting drug to patients worldwide."
With superior efficacy and safety profile, golidocitinib has
been widely acknowledged at prestigious international congresses
including ASCO, EHA, ICML, and ASH, with six oral presentations
over four consecutive years. The results of the multinational study
JACKPOT8 were published in Annals of Oncology and The
Lancet Oncology.
About golidocitinib (DZD4205)
Golidocitinib is currently the first and only Janus kinase 1
(JAK1) selective inhibitor being evaluated for the treatment of r/r
PTCL. In June 2024, golidocitinib was
approved by the National Medical Products Administration (NMPA) of
China for the treatment of adult
patients with relapsed or refractory peripheral T-cell lymphoma
(r/r PTCL).
At the data cut-off date of August 31,
2023, golidocitinib has demonstrated robust and durable
anti-tumor efficacy, with an ORR of 44.3%. More than 50% of the
patients with tumor remission achieved a complete response with a
CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months.
Golidocitinib was granted Fast Track Designation by the U.S. FDA
for the treatment of r/r PTCL in February
2022. In September 2023, the
CDE accepted its NDA and granted Priority Review for the treatment
of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8
PART A) was published in Annals of Oncology (Impact
Factor: 51.8), and global pivotal trial data of golidocitinib for
the treatment of r/r PTCL (JACKPOT PART B) was published
in The Lancet Oncology (Impact Factor: 54.4).
About Dizal
Dizal is a biopharmaceutical company, dedicated to the
discovery, development and commercialization of differentiated
therapeutics for the treatment of cancer and immunological
diseases. The company aims to develop first-in-class and
groundbreaking new medicines, and further address unmet medical
needs worldwide. Deep-rooted in translational science and molecular
design, it has established an internationally competitive portfolio
with two leading assets in global pivotal studies, both of which
have already been launched in China.
To learn more about Dizal, please
visit www.dizalpharma.com, or follow us
on Linkedin or Twitter.
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Contacts
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Business Development: bd@dizalpharma.com
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