TIDMHCM
Hutchmed (China) Limited
13 July 2021
Press Release
HUTCHMED Announces First Commercial Sale of ORPATHYS (R) in
China, Triggering a US$25 million Milestone Payment from
AstraZeneca
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, July 13,
2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:
13) announces the first commercial sale in China of ORPATHYS(R)
(savolitinib), HUTCHMED's oral, potent, and highly selective small
molecule inhibitor of MET, a receptor tyrosine kinase, which
occurred on July 12, 2021.
This follows less than three weeks after the June 22, 2021
approval of ORPATHYS(R) in China for the treatment of patients with
locally advanced or metastatic non-small cell lung cancer ("NSCLC")
with MET exon 14 skipping alterations who have progressed following
prior systemic therapy or are unable to receive chemotherapy.
Under the terms of the license and collaboration agreement
between HUTCHMED and AstraZeneca ("AstraZeneca") (LSE/STO/Nasdaq:
AZN), a US$25 million non-creditable and non-refundable milestone
payment is triggered by the first commercial sales of ORPATHYS(R)
in China. HUTCHMED is responsible for the clinical development,
marketing authorization, manufacturing and supply of ORPATHYS(R) in
China, while AstraZeneca is responsible for its commercialization
for which it will pay HUTCHMED fixed royalties of 30% based on all
China sales.
More than a third of the world's lung cancer patients are in
China and, among those with NSCLC, approximately 2-3% have tumors
with MET exon 14 skipping alterations, a targetable mutation in the
MET gene. [1](, [2] , [3]) This mutation is more common (13-22%)
among patients with pulmonary sarcomatoid carcinoma (PSC), a rare
and aggressive subtype of NSCLC usually resistant to
chemotherapy.(1) (, [4])
About ORPATHYS(R)
ORPATHYS(R) is an oral, potent, and highly selective MET
tyrosine kinase inhibitor ("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) or gene amplification.
ORPATHYS(R) is marketed 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. 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.
ORPATHYS(R) development in NSCLC
Phase II study of ORPATHYS(R) monotherapy in MET Exon 14
skipping alteration NSCLC ( NCT02897479 ) - In June 2021,
ORPATHYS(R) was granted drug registration conditional approval by
the National Medical Products Administration of China (NMPA) for
MET Exon 14 skipping alteration NSCLC. The approval was based on
the results of a Phase II study in China; results of this study
were presented during the American Society of Clinical Oncology
ASCO20 Virtual Scientific Program in May 2020, and updated results
were published in The Lancet Respiratory Medicine in June 2021. At
a median follow up of 17.6 months, ORPATHYS (R) demonstrated an
objective response rate ("ORR") of 42.9% (95% confidence interval
[CI] 31.1-55.3) and median progression-free survival ("PFS") of 6.8
months (95% CI 4.2-9.6) in the overall trial population. PFS was
clinically meaningful across subgroups, and ORR results were
consistent regardless of prior treatment or tumor histology,
including in patients with the PSC subtype (40.0%, 95% CI
21.1-61.3) and patients with other NSCLC subtypes (44.4%, 95% CI
29.6-60.0). Disease control rate ("DCR") in the overall trial
population was 82.9% (95% CI 72.0-90.8). The safety and
tolerability profile of ORPATHYS (R) was consistent with previous
trials, and no new safety signals were identified.
SAVANNAH Phase II study of ORPATHYS(R) in combination with
TAGRISSO (R) in patients who have progressed following TAGRISSO(R)
due to MET amplification or overexpression ( NCT03778229 ) - This
is a single-arm, open-label, global study in epidermal growth
factor receptor ("EGFR") mutation positive NSCLC patients with MET
amplified/overexpressed tumors following progression after
treatment with TAGRISSO(R) , an EGFR TKI owned by AstraZeneca.
Phase III study of ORPATHYS(R) in combination with TAGRISSO(R)
in patients who have progressed following EGFR TKI treatment due to
MET amplification (in planning) - This is a randomized, open-label
study in China in EGFR mutation positive NSCLC patients with MET
amplified tumors following progression after treatment with any
EGFR TKI.
Phase III study of ORPATHYS(R) in combination with TAGRISSO(R)
in treatment naïve patients with EGFR mutant positive NSCLC with
MET overexpression (in planning) - This is a randomized, blinded
study in China in untreated, unresectable or metastatic patients
with EGFR mutation positive NSCLC with MET positive tumors.
ORPATHYS(R) development in kidney cancer
SAVOIR randomized, controlled study of ORPATHYS(R) monotherapy
in MET-driven papillary renal cell carcinoma ("RCC") ( NCT03091192
) - In May 2020, data from 60 patients in this global study of
ORPATHYS(R) monotherapy compared with sunitinib monotherapy in
MET-driven papillary RCC was presented at the ASCO 2020 Program and
published simultaneously in JAMA Oncology. ORPATHYS(R) demonstrated
encouraging activity, including an ORR of 27% versus 7% for
sunitinib, with no ORPATHYS(R) responding patients experiencing
disease progression at data cut-off, and an encouraging overall
survival ("OS") hazard ratio of 0.51 (95% CI: 0.21-1.17; p=0.110)
with median not reached at data cut-off.
CALYPSO Phase I/II study of ORPATHYS(R) in combination with
IMFINZI(R) PD-L1 inhibitor in RCC ( NCT02819596 ) - The CALYPSO
study is an investigator initiated open-label Phase I/II study of
ORPATHYS(R) in combination with IMFINZI(R) , a PD-L1 antibody owned
by AstraZeneca. The study is evaluating the safety and efficacy of
the ORPATHYS(R) /IMFINZI(R) combination in patients with papillary
RCC and clear cell RCC. An analysis of 41 patients enrolled in the
PRCC cohort of in this study was presented at the 2021 ASCO Annual
Meeting, showing a confirmed response rate in 14 MET-driven
patients of 57%, with a median duration of response ("DoR") of 9.4
months, median PFS of 10.5 months and median OS of 27.4 months. No
new safety signals were seen.
Phase III in combination with IMFINZI(R) PD-L1 inhibitor in
MET-driven, unresectable and locally advanced or metastatic PRCC
(in planning) - Based on the encouraging results of the SAVOIR and
CALYPSO studies, we intend to initiate a global Phase III,
open-label, randomized, controlled study of ORPATHYS(R) plus
IMFINZI(R) versus sunitinib monotherapy versus IMFINZI(R)
monotherapy in patients with MET-driven, unresectable and locally
advanced or metastatic PRCC.
ORPATHYS(R) development in other cancer indications
Phase II study of ORPATHYS(R) monotherapy in advanced or
metastatic MET amplified gastric cancer ("GC") or adenocarcinoma of
the gastroesophageal junction ("GEJ") ( NCT04923932 ) - This Phase
II trial is an open-label, two-cohort, multi-center study to
evaluate the efficacy, safety and pharmacokinetics ("PK") of
ORPATHYS(R) in locally advanced or metastatic GC or GEJ patients
whose disease progressed after at least one line of standard
therapy. The primary endpoint is ORR as assessed by an independent
review committee. Other endpoints include 12-week and 6-month PFS
rates, median PFS, DoR, DCR, median OS, safety, PK and quality of
life.
This trial follows multiple Phase II studies that have been
conducted in Asia to study ORPATHYS(R) in MET-driven gastric cancer
patients, including VIKTORY. [5] VIKTORY is an investigator
initiated Phase II umbrella study in gastric cancer in South Korea
in which a total of 715 patients were successfully sequenced into
molecular-driven patient groups, including those with MET amplified
gastric cancer. Patients whose tumors harbor MET amplification were
treated with ORPATHYS(R) monotherapy, reporting an ORR of 50%
(10/20, 95% CI: 28.0, 71.9).
ORPATHYS(R) opportunities are also continuing to be explored in
multiple other MET-driven tumor settings via investigator-initiated
studies including non-small cell lung cancer, gastric cancer and
colorectal cancer.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery and global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. A dedicated organization of over 1,300
personnel has advanced ten cancer drug candidates from in-house
discovery into clinical studies around the world, with its first
three oncology drugs now approved and marketed. For more
information, please visit: www.hutch-med.com or follow us on
LinkedIn.
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, including its expectations regarding the commercial launch
of ORPATHYS(R) in China, our ability to manufacture and supply
ORPATHYS(R) , the ability of its partner AstraZeneca to distribute
ORPATHYS(R) quickly and broadly, the potential market for
ORPATHYS(R) in non-small cell lung cancer patients China, and the
further clinical development for ORPATHYS(R) in these and other
indications and in combination with other medicines in China, the
United States and other jurisdictions. Forward-looking statements
involve risks and uncertainties. Such risks and uncertainties
include, among other things, assumptions regarding AstraZeneca's
ability to effectively commercialize ORPATHYS(R) , the benefits
obtained from ORPATHYS(R) during clinical trials being the same for
all patients who are prescribed
ORPATHYS(R) , no unidentified side effects occurring which could
result in the NMPA pulling ORPATHYS(R) from the market, AstraZeneca
and HUTCHMED's ability to fund, implement and complete further
clinical development and commercialization plans for ORPATHYS(R) ,
the timing of these events, and the impact of the COVID-19 pandemic
on general economic, regulatory and political conditions. In
addition, as certain studies rely on the use of TAGRISSO(R) and
IMFINZI(R) as combination therapeutics with ORPATHYS(R) , such
risks and uncertainties include assumptions regarding the safety,
efficacy, supply and continued regulatory approval of these
therapeutics. 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, on AIM and The Stock Exchange of Hong Kong
Limited. 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.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, +852 9850 5033 (Mobile) / +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] 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. doi:
10.1016/j.lungcan.2018.07.006 .
[2] World Health Organization. International Agency for Research
on Cancer. Lung Fact Sheet. Available at
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed June 2021.
[3] World Health Organization. International Agency for Research
on Cancer. Globocan China Fact Sheet 2020. Available at
http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Accessed June 2021.
[4] Liu X, et al. Next-generation sequencing of pulmonary
sarcomatoid carcinoma reveals high frequency of actionable MET gene
mutations. J Clin Oncol 2016; 34: 794-802. doi:
10.1200/JCO.2015.62.0674 .
[5] Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides
Patients with Metastatic Gastric Cancer to Targeted Treatment: The
VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405.
doi:10.1158/2159-8290.CD-19-0442.
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