RCS - Hutchmed China Ltd - Full Approval for ORPATHYS in China

HUTCHMED (China)Announcement

14/01/2025 07:00

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RNS Number : 2352T  Hutchmed (China) Limited  14 January 2025

Press Release

 

HUTCHMED Announces NMPA Full Approval for ORPATHYS(®) (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

 

- Indication expands to include treatment-naïve patients -

 

- The 2021 conditional approval in previously treated patients converted to
full approval -

 

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, January 14, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM: HCM; HKEX: 13) today announces that the supplemental New Drug
Application  for ORPATHYS(®) (savolitinib) has been granted approval by the
China National Medical Products Administration ("NMPA") for the treatment of
adult patients with locally advanced or metastatic non-small cell lung cancer
("NSCLC") with MET exon 14 skipping alteration. The NMPA has also converted
the prior conditional approval of ORPATHYS(®) in the previously treated
patient population to full approval. The new label indication for ORPATHYS(®)
will now include both treatment-naïve and previously treated patients in
China.

 

The approval by the NMPA was based on data from the confirmatory Phase IIIb
clinical trial in patients with MET exon 14 skipping alteration NSCLC
(NCT04923945 (https://www.clinicaltrials.gov/study/NCT04923945) ). Preliminary
efficacy and safety data from the first-line cohort 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 in March 2024.

 

In treatment-naïve patients, objective response rate ("ORR") was 62.1%,
disease control rate ("DCR") was 92.0% and median duration of response ("DoR")
was 12.5 months, as assessed by an independent review committee. Median
progression free survival ("PFS") was 13.7 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%, DCR was 92.4% and median DoR was 11.1 months,
as assessed by an independent review committee. Median PFS was 11.0 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%).

 

"This Phase IIIb confirmatory study of ORPATHYS(®) is one of the largest
Phase III clinical trials conducted in China for this patient population to
date. ORPATHYS(®) has demonstrated clear efficacy and tolerability in both
first-line and second-line settings, underscoring its potential as a standard
treatment option for NSCLC with MET exon 14 skipping alterations," said Prof.
Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital,
School of Medicine, Shanghai Jiaotong University, and Principal Investigator
of the confirmatory Phase IIIb study. "By making ORPATHYS(®) available as a
first-line treatment, we are able to provide our patients with an effective
targeted therapy earlier in their treatment journey. We look forward to
introducing this novel treatment and optimizing the treatment strategy for
this challenging patient population to improve their outcomes and quality of
life."

 

"The approval marks an exciting step forward in addressing the unmet needs of
NSCLC patients with MET exon 14 skipping alteration.  It not only validates
our research but also emphasizes our dedication to addressing unmet medical
needs through targeted drug development," said Dr. Michael Shi, Head of
R&D and Chief Medical Officer of HUTCHMED. "We are focused on advancing
our research and expanding access to ORPATHYS(®), ultimately improving the
treatment landscape for those affected by this challenging form of lung
cancer. We also remain committed to further exploring ORPATHYS(®) in other
MET driven diseases in order to help more patients who may benefit from this
targeted treatment."

 

"Today's approval reinforces ORPATHYS(®) as a transformative option for the
treatment of biomarker-driven lung cancer, and we are proud that we can now
offer this therapy to both first-line and second-line patients in China with
advanced NSCLC with MET exon 14 skipping alterations," said Ms. Mary Guan,
General Manager of AstraZeneca China Oncology Business. "Through our
partnership with HUTCHMED, we are advancing ORPATHYS(®) to address resistance
to EGFR-TKIs 1 , unlocking new possibilities for treating MET-altered and
amplified cancers, and expanding the reach of this innovative therapy to even
more patients with this form of lung cancer."

 

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.

 

About NSCLC and MET aberrations

 

Lung cancer is the leading cause of cancer death, accounting for about
one-fifth of all cancer deaths. 2  More than a third of the world's lung
cancer patients are in China. Lung cancer is broadly split into NSCLC and
small cell lung cancer, with 80-85% classified as NSCLC. 3  The majority of
NSCLC patients (approximately 75%) are diagnosed with advanced disease, and
approximately 10-15% of NSCLC patients in the US and Europe and 30-40% of
patients in Asia have EGFR-mutated NSCLC.  4 (,) 5 (,) 6 (,) 7 

 

MET is a tyrosine kinase receptor that has an essential role in normal cell
development. 8  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 TKI for metastatic EGFR-mutated
NSCLC.(8,) 9  Approximately 2-3% of NSCLC patients have tumors with MET exon
14 skipping alterations, a targetable mutation in the MET gene. 10  MET
aberration is a major mechanism for acquired resistance to both
first/second-generation EGFR TKIs as well as third-generation EGFR TKIs like
osimertinib. Among patients who experience disease progression
post-osimertinib treatment, approximately 15-50% present with MET
aberration. 11 (,) 12 (,) 13 (,) 14 (,) 15  The prevalence of MET aberration
depends on the sample type, detection method and assay thresholds used. 16 

 

About ORPATHYS(®) (savolitinib)

 

ORPATHYS(®) is an oral, potent and highly selective MET TKI 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.

 

ORPATHYS(®) was previously granted conditional approval
(https://www.hutch-med.com/savolitinib-approved-in-china-for-patients-with-lung-cancer-with-met-exon-14-skipping-alterations/)
in China in June 2021 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. ORPATHYS(®) is the first selective
MET inhibitor approved in China. It has been included
(https://www.hutch-med.com/orpathys-nrdl-inclusion/) in the National
Reimbursement Drug List of China (NRDL) since March 2023. It is also currently
under clinical development for multiple tumor types, including lung, kidney
and gastric cancers, as a single treatment and in combination with other
medicines.

 

In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration
agreement to jointly develop and commercialize ORPATHYS(®). Joint development
of ORPATHYS(®) in China is led by HUTCHMED, while AstraZeneca leads
development outside of China. HUTCHMED is responsible for the marketing
authorization, manufacturing and supply of ORPATHYS(®) in China. AstraZeneca
is responsible for the commercialization of ORPATHYS(®) in China and
worldwide. Sales of ORPATHYS(®) 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. Since inception,
HUTCHMED has focused on bringing 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 approved in the US, Europe and Japan. 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 US 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 other
jurisdictions and to gain commercial acceptance after obtaining regulatory
approval; the potential market of savolitinib for a targeted indication; and
HUTCHMED and/or its partner's ability to fund, implement and complete its
further clinical development and commercialization plans for savolitinib, and
the timing of these events. 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 US 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
 FTI Consulting -                                     +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                      (mailto:HUTCHMED@fticonsulting.com)
    Ben Atwell / Alex Shaw                             +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
 Brunswick - Zhou Yi                                  +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                      (mailto:HUTCHMED@brunswickgroup.com)

 Panmure Liberum                                      Nominated Advisor and Joint Broker
 Atholl Tweedie / Freddy Crossley / Rupert Dearden    +44 20 7886 2500

 HSBC                                                 Joint Broker
 Simon Alexander / Alina Vaskina / Arnav Kapoor       +44 20 7991 8888

 Cavendish                                            Joint Broker
 Geoff Nash / Nigel Birks                             +44 20 7220 0500

 

 1   EGFR = epidermal growth factor receptor; TKI = tyrosine kinase
inhibitor.

 2   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.

 3   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.

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

 5  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.

 6  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).

 7  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.

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

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

 10  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.

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

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

 13  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.

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

 15  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.

 16  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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