RCS - Hutchmed China Ltd - Savolitinib sNDA Accepted in China

HUTCHMED (China)Announcement

28/03/2024 07:15

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RNS Number : 5584I  Hutchmed (China) Limited  28 March 2024

Press Release

 

HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

 

- Oral presentation at the European Lung Cancer Congress 2024 of Phase IIIb
data demonstrating median PFS of 13.7 months and median OS not reached in
treatment-naïve patients -

 

- If approved, would confirm 2021 conditional approval and expand indication
to more patients -

 

Hong Kong, Shanghai & Florham Park, NJ - Thursday, March 28, 2024:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug
Application ("sNDA") for savolitinib, in adult patients with locally advanced
or metastatic non-small cell lung cancer ("NSCLC") with mesenchymal epithelial
transition factor ("MET") exon 14 skipping alteration, has been accepted for
review by the China National Medical Products Administration (NMPA). If
approved, the new label indication for savolitinib will be expanded to include
treatment-naive patients in China.

 

Savolitinib was previously granted conditional approval in China for the
treatment of patients with NSCLC with MET exon 14 skipping alterations who
have progressed following prior systemic therapy or are unable to receive
chemotherapy. Savolitinib was launched and is marketed under the brand name
ORPATHYS(®) by our partner, AstraZeneca for this patient population,
representing the first selective MET inhibitor approved in China. More than a
third of the world's lung cancer patients are in China and, among those with
NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping
alterations.

 

Preliminary efficacy and safety data from the first-line cohort of the
confirmatory Phase IIIb clinical trial (NCT04923945
(https://www.clinicaltrials.gov/study/NCT04923945) ) were presented during the
IASLC World Conference on Lung Cancer (WCLC) in September 2023. Final data
from the confirmatory Phase IIIb trial were presented at the European Lung
Cancer Congress on March 20, 2024.

 

The data from this study provide confirmatory evidence for savolitinib as a
targeted treatment option for treatment-naïve or previously treated patients
with MET exon 14 skipping alteration NSCLC. In treatment-naïve patients,
objective response rate ("ORR") was 62.1% (95% CI: 51.0% to 72.3%), disease
control rate ("DCR") was 92.0% (95% CI: 84.1% to 96.7%) and median duration of
response ("DoR") was 12.5 months (95% CI: 8.3 months to 15.2 months), as
assessed by an independent review committee. Median progression free survival
("PFS") was 13.7 months (95% CI: 8.5 months to 16.6 months) and median overall
survival ("OS") was not reached with median follow-up of 20.8 months. In
previously treated patients, ORR was 39.2% (95% CI: 28.4% to 50.9%), DCR was
92.4% (95% CI: 84.2% to 97.2%) and median DoR was 11.1 months (95% CI: 6.6
months to not reached), as assessed by an independent review committee. Median
PFS was 11.0 months (95% CI: 8.3 months to 16.6 months) and median OS was not
mature with median follow-up of 12.5 months. Responses occurred early (time to
response 1.4-1.6 months) in both treatment-naïve and previously treated
patients. The safety profile was tolerable and no new safety signals were
observed. The most common drug-related treatment-emergent adverse events of
Grade 3 or above (5% or more of patients) were abnormal hepatic function
(16.9%), increased alanine aminotransferase (14.5%), increased aspartate
aminotransferase (12.0%), peripheral oedema (6.0%) and increased
gamma-glutamyltransferase (6.0%).

 

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death among men and women,
accounting for about one-fifth of all cancer deaths. 1  Lung cancer is broadly
split into NSCLC and small cell lung cancer, with 80-85% classified as
NSCLC. 2  The majority of NSCLC patients (approximately 75%) are diagnosed
with advanced disease, and approximately 10-15% of NSCLC patients in the U.S.
and Europe and 30-40% of patients in Asia have EGFRm NSCLC.
 3 (,) 4 (,) 5 (,) 6 

 

MET is a tyrosine kinase receptor that has an essential role in normal cell
development. 7  MET overexpression and/or amplification can lead to tumor
growth and the metastatic progression of cancer cells, and is one of the
mechanisms of acquired resistance to EGFR TKIs for metastatic EGFR-mutated
NSCLC.(7)(,) 8  Approximately 2-3% of NSCLC patients have tumors with MET exon
14 skipping alterations, a targetable mutation in the MET gene. 9  Among
patients who experience disease progression post-osimertinib treatment,
approximately 15-50% present with MET
aberration. 10 (,) 11 (,) 12 (,) 13 (,) 14  The prevalence of MET depends on
the sample type, detection method and assay cut-off used. 15 

 

About Savolitinib (ORPATHYS(®) in China)

Savolitinib is an oral, potent and highly selective MET tyrosine kinase
inhibitor that has demonstrated clinical activity in advanced solid tumors. It
blocks atypical activation of the MET receptor tyrosine kinase pathway that
occurs because of mutations (such as exon 14 skipping alterations or other
point mutations), gene amplification or protein overexpression.

 

Savolitinib is marketed
(https://www.hutch-med.com/first-commercial-sale-of-orpathys-milestone-payment/)
in China under the brand name ORPATHYS(®) for the treatment of patients with
non-small cell lung cancer with MET exon 14 skipping alterations who have
progressed following prior systemic therapy or are unable to receive
chemotherapy. It is currently under clinical development for multiple tumor
types, including lung, kidney and gastric cancers, as a single treatment and
in combination with other medicines. Starting on March 1, 2023, ORPATHYS(®)
was included (https://www.hutch-med.com/orpathys-nrdl-inclusion/) in the
National Reimbursement Drug List (NRDL) for the treatment of locally advanced
or metastatic NSCLC adult patients with MET exon 14-skipping alterations who
have progressed after or unable to tolerate platinum-based chemotherapy.

 

In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration
agreement to jointly develop and commercialize savolitinib. Joint development
of savolitinib in China is led by HUTCHMED, while AstraZeneca leads
development outside of China. HUTCHMED is responsible for the marketing
authorization, manufacturing and supply of savolitinib in China. AstraZeneca
is responsible for the commercialization of savolitinib in China and
worldwide. Sales of savolitinib are recognized by AstraZeneca.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage,
biopharmaceutical company. It is committed to the discovery, global
development and commercialization of targeted therapies and immunotherapies
for the treatment of cancer and immunological diseases. It has approximately
5,000 personnel across all its companies, at the center of which is a team of
about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on
bringing cancer drug candidates from in-house discovery to patients around the
world, with its first three medicines marketed in China, the first of which is
also marketed in the U.S. For more information, please visit:
www.hutch‑med.com (https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the U.S. Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect HUTCHMED's current
expectations regarding future events, includ-ing its expectations regarding
the thera-peutic potential of savolitinib, the further clinical develop-ment
for savolitinib, its expectations as to whether any studies on savolitinib
would meet their primary or secondary endpoints, and its expectations as to
the timing of the completion and the release of results from such studies.
Forward-looking statements involve risks and uncertainties. Such risks and
uncertainties include, among other things, assumptions regarding enrollment
rates and the timing and availability of subjects meeting a study's inclusion
and exclusion criteria; changes to clinical protocols or regulatory
requirements; unexpected adverse events or safety issues; the ability of
savolitinib, including as a combination therapy, to meet the primary or
secondary endpoint of a study, to obtain regulatory approval in different
jurisdictions and to gain commercial acceptance after obtaining regulatory
approval; the potential market of savolitinib for a targeted indication; and
the sufficiency of funding. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements, which speak
only as of the date hereof. For further discussion of these and other risks,
see HUTCHMED's filings with the U.S. Securities and Exchange Commission, The
Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no
obligation to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise.

 

Medical Information

This press release contains information about products that may not be
available in all countries, or may be available under different trademarks,
for different indications, in different dosages, or in different strengths.
Nothing contained herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under development.

 

CONTACTS

 

 Investor Enquiries                                                     +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 Ben Atwell / Alex Shaw, FTI Consulting                                 +44 20 3727 1030 / +44 7771 913 902 (Mobile) /
                                                                        +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
                                                                        (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi, Brunswick                                                     +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                        (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon        +44 (20) 7886 2500

 

 

 1    World Health Organization. International Agency for Research on
Cancer. All cancers fact sheet. Available at:
https://gco.iarc.fr/today/-data/factsheets/cancers/39-All-cancers-fact-sheet.pdf
(https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf)
. Accessed November 2022.

 2    American Cancer Society. What is Lung Cancer? Available at:
https://www.cancer.org/cancer/lung-cancer/about/what-is.html
(https://www.cancer.org/cancer/lung-cancer/about/what-is.html) . Accessed
November 2022.

 3    Knight SB, et al. Progress and prospects of early detection in lung
cancer. Open Biol. 2017;7(9): 170070.

 4    Keedy VL, et al. American Society of Clinical Oncology Provisional
Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for
Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR
Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.

 5    Zhang Y, et al. The prevalence of EGFR mutation in patients with
non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget.
2016;7(48).

 6    Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological
and Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single
Institution Study and Systematic Review of European Incidence. Int J Clin
Exp Pathol. 2013:6;2800-12.

 7    Uchikawa E, et al. Structural basis of the activation of c-MET
receptor. Nat Commun. 2021;12(4074).

 8    Wang Q, et al. MET inhibitors for targeted therapy of EGFR
TKI-resistant lung cancer. Journal of Hematology & Oncology. 2019;63.

 9    Vuong HG, et al. Clinicopathological implications of MET exon 14
mutations in non-small cell lung cancer - A systematic review and
meta-analysis. Lung Cancer 2018; 123: 76-82.

 10              Soria JC, et al. Osimertinib in Untreated
EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med.
2018;378(2):113-125.

 11  Mok TS, et al. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive
Lung Cancer. N Engl J Med. 2017;376(7):629-640.

 12  Hartmaier R, et al. Tumor genomics in patients (pts) with advanced
epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer
(NSCLC) whose disease has progressed on first-line (1L) osimertinib therapy in
the Phase II ORCHARD study. Cancer Res 15 June 2022; 82
(12_Supplement): LB078.

 13  Piotrowska, et al.  MET amplification (amp) as a resistance mechanism to
osimertinib. Journal of Clinical Oncology 2017 35:15_suppl, 9020-9020.

 14  Hartmaier, et al. Detection of MET-mediated EGFR tyrosine kinase
inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC):
biomarker analysis of the TATTON study. Cancer Res (2019) 79 (13_Supplement):
4897.

 15  Coleman N, et al. Beyond epidermal growth factor receptor: MET
amplification as a general resistance driver to targeted therapy in
oncogene-driven non-small-cell lung cancer. ESMO Open. 2019;6(6).

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