CHENGDU, China, Aug. 20, 2024 /PRNewswire/ -- On
August 20, the new drug application
(NDA) for the core product sacituzumab tirumotecan (sac-TMT,
formerly SKB264/MK-2870) based on the positive results from the
pivotal OptiTROP-Lung03 study has been accepted by the Center for
Drug Evaluation (CDE) of the National Medical Products
Administration (NMPA) of China,
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech",
6990.HK)
![KELUN-BIOTECH KELUN-BIOTECH](https://mma.prnewswire.com/media/2485418/KELUN_BIOTECH.jpg)
OptiTROP-Lung03 is a multi-center, randomized, pivotal clinical
study that evaluates sac-TMT monotherapy 5mg/kg every other week
(Q2W) as an intravenous injection versus docetaxel for the
treatment of patients with locally advanced or metastatic epidermal
growth factor receptor (EGFR)-mutant non-small cell lung cancer
(NSCLC) who failed after treatment with EGFR-tyrosine kinase
inhibitor (TKI) therapy and platinum-based chemotherapy. At a
pre-specified analysis, sac-TMT monotherapy demonstrated a
statistically significant and clinically meaningful improvement in
objective response rate (ORR) and progression-free survival (PFS)
compared with docetaxel.
Lung cancer mainly includes non-small cell lung cancer (NSCLC)
and small cell lung cancer (SCLC), of which NSCLC is the most
common pathological type, accounting for about 80%-85% of all lung
cancers. The molecular typing of NSCLC patients in China is different from that of Western
populations, and EGFR mutation is a common variant gene type,
accounting for about 40%-50% of lung adenocarcinoma patients in
China [1].
According to the 2024 CSCO guidelines, EGFR-TKIs are the preferred
treatment for stage IV EGFR-mutant NSCLC [2];
platinum-containing chemotherapy is the main first-line
chemotherapy regimen after resistance to EGFR-TKIs; and existing
treatment regimens are ineffective in those who have failed
EGFR-TKIs and platinum-containing chemotherapy. Single-agent
chemotherapy is the current standard of care for this population,
and docetaxel is the most commonly used single-agent chemotherapy,
with an ORR of 3.2%-10.8%, a median PFS of only about 2 months, and
a median OS of about 6-8 months [3,4,5,6,7]. For
patients with locally advanced or metastatic EGFR-mutated NSCLC who
have failed treatment with EGFR-TKIs and who have failed
platinum-containing chemotherapy, the existing treatment regimens
are less efficacious, there is a large unmet clinical need, and new
drugs are urgently needed to improve patient survival.
Kelun-Biotech has filed the Application for sac-TMT for
injection for the treatment of patients with locally advanced or
metastatic EGFR-mutant NSCLC who failed after treatment with an
EGFR-TKI and platinum-based chemotherapy.
The Application is the second NDA for sac-TMT that has been
accepted by the NMPA. On August 14, 2024, it was announced on
the official website of the CDE that the Application was
planned to be included in the priority review and approval
process of the CDE. Previously, an NDA for sac-TMT in patients
with locally advanced or metastatic triple-negative breast cancer
(TNBC) who have received at least two prior systemic therapies
(at least one of them for advanced or metastatic setting) was
accepted by the NMPA.
![CEO Ge Junyou CEO Ge Junyou](https://mma.prnewswire.com/media/2485419/CEO_Ge_Junyou.jpg)
Dr. Junyou Ge, CEO of Kelun-Biotech, said, "It is a great honor
to have the second NDA of SKB264 accepted. Kelun-Biotech has always
adhered to an innovation-driven development strategy, actively
exploring cutting-edge technologies and new approaches to the
treatment of major diseases. In response to unmet medical needs, we
are committed to the original innovation of new drugs with
differentiated advantages and international potential. By enhancing
our end-to-end innovative drug development capabilities, we
continuously improve the efficiency and success rate of drug
research and development, and make every effort to move forward our
clinical research progress. We are dedicated to continuously
exploring and rapidly validating the clinical value of core
projects. The company will always be guided by a caring heart,
striving for excellence, and contributing to the great global
oncology health cause."
About Kelun-Biotech
Kelun-Biotech(6990.HK)is a holding subsidiary of Kelun
Pharmaceutical (002422.SZ), which focuses on the R&D,
manufacturing, commercialization and global collaboration of
innovative biological drugs and small molecule drugs. The company
focuses on major disease areas such as solid tumors, autoimmune,
inflammatory, and metabolic diseases, and in establishing a
globalized drug development and industrialization platform to
address the unmet medical needs in China and the rest of world. The Company is
committed to becoming a leading global enterprise in the field of
innovative drugs.
At present, the Company has more than 30 ongoing innovative
projects in major disease areas such as solid tumors, autoimmune,
inflammatory, and metabolic diseases, including over 10 projects in
the clinical stage and 4 projects in the NDA stage with several
global trials being conducted simultaneously in multiple countries,
including China, Europe, and the
United States. The company has established one of the
world's leading proprietary ADC platforms, OptiDC™, and has 5 ADC
projects in the clinical stage (2 of which are in the NDA stage)
and several projects in the preclinical stage. For more
information, please visit https://kelun-biotech.com/.
References:
|
[1] [Chinese Society of
Clinical Oncology (CSCO)(2024)] Guidelines for the diagnosis and
treatment of non-small cell lung cancer.
|
[2] [Chinese Society of
Clinical Oncology (CSCO)(2024)] Guidelines for the diagnosis and
treatment of non-small cell lung cancer.
|
[3] Hanna N,Shepherd
FA, Fossella Fv, et al.(2004)
|
[4] Randomized Phase
lll Trial of Pemetrexed, versus Docetaxel in Patients with
Non-Small-Cell Lung CancerPreviously Treated with
Chemotherapy.Journa otClcaOncology,22:1589-1597.
|
[5] Jyoti D. Patel,
Mleng J, et al. (2023) Clinical charateristics, real-world
treatment patterns, and clinicaloutcomes among patients with
previously treated metastatic or unresectable EGFR-mutated
non-small cellung cancer in the United States. Cancer
Research.83:6754.
|
[6] KawaguchiT, Ando M.
Asami K, et a. 2014) Randomized phase ll trlal of erlotnib versus
docetaxe assecond- or third-line therapy in patients with advanced
non-small-cell lung cancer. Docetaxel and Erlotinibung Cancerlra
(DEhA)Journa of cinica32(18):1902-1908.
|
[7] Krzakowski M,
Ramlau R, Jassem J, et al. (2010)] Phase Ⅲ trial comparing
vinflunine with docetaxel in second-line advanced non-small-cell
lung cancer previously treated with platinum-containing
chemotherapy. Journal of Clinical Oncology, 28(1.
|
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SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.