Junshi Biosciences Announces Approval of the sNDA for Toripalimab
for the 1st-Line Treatment of Small Cell Lung Cancer
Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX:
1877; SSE: 688180), a leading innovation-driven biopharmaceutical
company dedicated to the discovery, development, and
commercialization of novel therapies, announced that the National
Medical Products Administration (NMPA) has approved the
supplemental new drug application (sNDA) for toripalimab (product
code: JS001) in combination with etoposide plus platinum for the
first-line treatment of extensive-stage small cell lung cancer
(ES-SCLC).
Lung cancer is currently the most
prevalent malignant tumor with the highest mortality rate in China.
Small cell lung cancer (SCLC) is the most aggressive subtype of
lung cancer, accounting for approximately 15%-20% of all lung
cancer cases with characteristics including rapid progression,
early metastasis and poor prognosis. SCLC is divided into
limited-stage small cell lung cancer (LS-SCLC) and ES-SCLC. For
patients with LS-SCLC, an objective response rate of approximately
90% and a five-year survival rate of approximately 25% could be
achieved through standard chemotherapy and radiotherapy. However,
most patients have already been diagnosed with ES-SCLC when seeking
medical treatment, with a median survival time of less than one
year and a two-year survival rate of less than 10%, and thus
ES-SCLC remains a major unmet clinical problem.
The approval of the supplemental new
drug application is mainly based on data from the EXTENTORCH study
(NCT04012606), a randomized, double-blind, placebo-controlled,
multi-center Phase 3 clinical study, aiming to compare the efficacy
and safety of toripalimab or placebo in combination with etoposide
plus platinum for the first-line treatment of ES-SCLC. Led by
principal investigator Professor Ying CHENG from Jilin Cancer
Hospital, the study was conducted across 51 clinical centers
nationwide.
In May 2023, the primary endpoints of
EXTENTORCH met their pre-defined efficacy boundary, and toripalimab
thus became the first PD-1 inhibitor in the world to meet the
primary endpoints of both overall survival (OS) and
progression-free survival (PFS) in a Phase 3 study for the
first-line treatment of ES-SCLC.
At the European Society for Medical
Oncology (ESMO) Congress held in October 2023, the EXTENTORCH data
was released in the form of an oral presentation for the first
time. The study results showed that, compared to chemotherapy
alone, toripalimab in combination with chemotherapy could
significantly prolong the PFS and OS of patients and demonstrated a
favorable safety profile. This suggests that toripalimab may be an
optimal immunotherapy for ES-SCLC. In particular, the median PFS of
the toripalimab group reached 5.8 months, and the risk of disease
progression or death was reduced by 33.3% (P=0.0002). The one-year
PFS was nearly four times higher in the toripalimab group compared
with the chemotherapy group (18.1% vs. 4.9%). The median OS of the
toripalimab group reached 14.6 months, the risk of death was
reduced by 20.2% (P=0.0327), and the one-year OS reached 63.1%.
“SCLC is highly invasive,
mestastasizes early, and has a poor prognosis. For a long time, the
standard treatment of ES-SCLC has been platinum-based chemotherapy.
Although patients are responsive to the initial stage of treatment,
they are prone to drug resistance. Immunotherapy, however, has
opened a new chapter,” said Professor Ying CHENG from Jilin Cancer
Hospital. “The double primary endpoint design of PFS and OS in
EXTENTORCH followed a higher statistical standard and achieved
positive results for both endpoints. This means that compared to
mono-chemotherapy, toripalimab combined with chemotherapy can
significantly improve patients’ PFS and OS. The approval of
toripalimab’s new indication for the first-line treatment of
ES-SCLC will provide a new, effective, safe and affordable
treatment option for SCLC patients in China!”
“With the highest number of new cases
and deaths, lung cancer has always been the archenemy of tumor
treatment,” said Dr. Jianjun ZOU, General Manager and CEO of Junshi
Biosciences. “Junshi Biosciences has continuously invested in the
research and development of new drugs for lung cancer. To date,
three indications have been successfully approved, covering the
main subtypes of non-small cell lung cancer and SCLC, as well as
patients at all stages from early to advanced. More products and
indications are currently in development, and we look forward to
bringing better treatment options to lung cancer patients!”
About ToripalimabToripalimab is an anti-PD-1
monoclonal antibody developed for its ability to block PD-1
interactions with its ligands, PD-L1 and PD-L2, and for enhanced
receptor internalization (endocytosis function). Blocking PD-1
interactions with PD-L1 and PD-L2 promotes the immune system’s
ability to attack and kill tumor cells.
More than forty company-sponsored toripalimab clinical studies
covering more than fifteen indications have been conducted globally
by Junshi Biosciences, including in China, the United States,
Southeast Asia, and Europe. Ongoing or completed pivotal clinical
trials evaluating the safety and efficacy of toripalimab cover a
broad range of tumor types, including cancers of the lung,
nasopharynx, esophagus, stomach, bladder, breast, liver, kidney,
and skin.
In Chinese mainland, toripalimab was the first domestic
anti-PD-1 monoclonal antibody approved for marketing (approved in
China as TUOYI®). Currently, there are nine approved indications
for toripalimab in Chinese mainland:
- unresectable or metastatic melanoma after failure of standard
systemic therapy;
- recurrent or metastatic nasopharyngeal carcinoma (NPC) after
failure of at least two lines of prior systemic therapy;
- locally advanced or metastatic urothelial carcinoma that failed
platinum-containing chemotherapy or progressed within 12 months of
neoadjuvant or adjuvant platinum-containing chemotherapy;
- in combination with cisplatin and gemcitabine as the first-line
treatment for patients with locally recurrent or metastatic
NPC;
- in combination with paclitaxel and cisplatin in first-line
treatment of patients with unresectable locally advanced/recurrent
or distant metastatic esophageal squamous cell carcinoma
(ESCC);
- in combination with pemetrexed and platinum as the first-line
treatment in EGFR mutation-negative and ALK mutation-negative,
unresectable, locally advanced or metastatic non-squamous non-small
cell lung cancer (NSCLC);
- in combination with chemotherapy as perioperative treatment and
subsequently with monotherapy as adjuvant therapy for the treatment
of adult patients with resectable stage IIIA-IIIB NSCLC;
- in combination with axitinib for the first-line treatment of
patients with medium to high risk unresectable or metastatic renal
cell carcinoma (RCC);
- in combination with etoposide plus platinum for the first-line
treatment of extensive-stage small cell lung cancer (ES-SCLC).
The first six indications have been included in the National
Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the
only anti-PD-1 monoclonal antibody included in the NRDL for the
treatment of melanoma. In April 2024, the Drug Office at the
Department of Health in the Government of the Hong Kong Special
Administration Region (DO) accepted the NDA for toripalimab in
combination with cisplatin and gemcitabine for the first-line
treatment of adults with metastatic or recurrent locally advanced
NPC, and for toripalimab, as a single agent, for the treatment of
adults with recurrent, unresectable, or metastatic NPC with disease
progression on or after platinum-containing chemotherapy.
In the United States, the US FDA has approved the Biologics
License Application for toripalimab in combination with cisplatin
and gemcitabine for the first-line treatment of adults with
metastatic or recurrent locally advanced NPC, and for toripalimab,
as a single agent, for the treatment of adults with recurrent,
unresectable, or metastatic NPC with disease progression on or
after platinum-containing chemotherapy in October 2023. The FDA has
granted toripalimab 2 Breakthrough Therapy designations for the
treatment of NPC, 1 Fast Track designation for the treatment of
mucosal melanoma, and 5 Orphan Drug designations for the treatment
of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma,
and small cell lung cancer (SCLC).
In Europe, marketing authorization applications (MAA) were
accepted by the European Medicines Agency (EMA) and the MHRA for 1)
toripalimab combined with cisplatin and gemcitabine for the
first-line treatment of patients with locally recurrent or
metastatic NPC and 2) toripalimab combined with paclitaxel and
cisplatin for the first-line treatment of patients with
unresectable locally advanced/recurrent or metastatic ESCC, in
December 2022 and February 2023.
In Australia, the new chemical entity (NCE) application was
accepted by the Australia Therapeutic Goods Administration (TGA) in
November 2023. The TGA has also granted toripalimab an Orphan Drug
designation for the treatment of NPC.
In Singapore, the NDA application was accepted by the Singapore
Health Sciences Authority (HSA) in January 2024. The HSA has also
granted priority review designation for the NDA.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE:
688180) is an innovation-driven biopharmaceutical company dedicated
to the discovery, development and commercialization of innovative
therapeutics. The company has established a diversified R&D
pipeline comprising over 50 drug candidates, with five therapeutic
focus areas covering cancer, autoimmune, metabolic, neurological,
and infectious diseases. Four of the company’s innovations have
already reached the Chinese or international markets, one of which
is toripalimab, China’s first domestically produced and
independently developed anti-PD-1 monoclonal antibody, approved in
China and the US. Additionally, more than 30 drugs are currently in
clinical development. During the COVID-19 pandemic, Junshi
Biosciences actively shouldered the social responsibilities of a
Chinese pharmaceutical company through its involvement in
developing etesevimab, MINDEWEI®, and other novel therapies for the
prevention and treatment of COVID-19.
With a mission of “providing patients with world-class,
trustworthy, affordable, and innovative drugs”, Junshi Biosciences
is “In China, For Global.” At present, the company boasts
approximately 3,000 employees in the United States (San Francisco
and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou,
etc.). For more information, please visit:
http://junshipharma.com.
Junshi Biosciences Contact InformationIR
Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800
PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86
021-6105 8800