HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13)
announces the first commercial sale in China of ORPATHYS®
(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® 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® in China. HUTCHMED is responsible for
the clinical development, marketing authorization, manufacturing
and supply of ORPATHYS® 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®
ORPATHYS® 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® 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®
development in NSCLC
Phase II study of ORPATHYS® monotherapy in MET
Exon 14 skipping alteration NSCLC (NCT02897479) – In June 2021,
ORPATHYS® 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® 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® was consistent with previous
trials, and no new safety signals were identified.
SAVANNAH Phase II study of ORPATHYS® in
combination with TAGRISSO® in patients who have progressed
following TAGRISSO® 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®, an EGFR TKI owned by
AstraZeneca.
Phase III study of ORPATHYS® in combination with
TAGRISSO® 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® in combination with
TAGRISSO® 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®
development in kidney cancer
SAVOIR randomized, controlled study of ORPATHYS®
monotherapy in MET-driven papillary renal cell carcinoma (“RCC”)
(NCT03091192) – In May 2020, data from 60 patients in this global
study of ORPATHYS® monotherapy compared with sunitinib monotherapy
in MET-driven papillary RCC was presented at the ASCO 2020 Program
and published simultaneously in JAMA Oncology. ORPATHYS®
demonstrated encouraging activity, including an ORR of 27% versus
7% for sunitinib, with no ORPATHYS® 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® in
combination with IMFINZI® PD-L1 inhibitor in RCC (NCT02819596) –
The CALYPSO study is an investigator initiated open-label Phase
I/II study of ORPATHYS® in combination with IMFINZI®, a PD-L1
antibody owned by AstraZeneca. The study is evaluating the safety
and efficacy of the ORPATHYS®/IMFINZI® combination in patients with
papillary RCC and clear cell RCC. An analysis of 41 patients
enrolled in the PRCC cohort of 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® 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®
plus IMFINZI® versus sunitinib monotherapy versus IMFINZI®
monotherapy in patients with MET-driven, unresectable and locally
advanced or metastatic PRCC.
ORPATHYS®
development in other cancer indications
Phase II study of ORPATHYS® 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® 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® 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® monotherapy, reporting an
ORR of 50% (10/20, 95% CI: 28.0, 71.9).
ORPATHYS® 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® in China, our ability to manufacture
and supply ORPATHYS®, the ability of its partner AstraZeneca to
distribute ORPATHYS® quickly and broadly, the potential market for
ORPATHYS® in non-small cell lung cancer patients in China, and the
further clinical development for ORPATHYS® 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®, the benefits
obtained from ORPATHYS® during clinical trials being the same for
all patients who are prescribed ORPATHYS®, no unidentified side
effects occurring which could result in the NMPA pulling ORPATHYS®
from the market, AstraZeneca and HUTCHMED’s ability to fund,
implement and complete further clinical development and
commercialization plans for ORPATHYS®, 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® and IMFINZI® as combination
therapeutics with ORPATHYS®, 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, Solebury Trout |
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com |
Europe – Ben Atwell / Alex Shaw, FTI
Consulting |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile)
HUTCHMED@fticonsulting.com |
Asia – Joseph Chi Lo / Zhou Yi, Brunswick |
+852 9850 5033 (Mobile)
/
+852 9783 6894 (Mobile)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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