阿斯利康6-K备案SANOVO III期阳性结果（与和黄医药8月31日港交所公告为同一事件，无新增信息）

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6-K
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a7347s.htm
TAGRISSO + ORPATHYS IMPROVED PFS IN 1L EGFRM LUNG
a7347s
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of September 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Tagrisso + Orpathys improved PFS in 1L EGFRm
lung
1 September 2026
Tagrisso
plus
Orpathys
demonstrated
statistically significant and highly clinically meaningful
improvement in progression-free survival in
1st-line
MET-overexpressing EGFR-mutated lung cancer
Results of SANOVO Phase III trial in China build on
established success of global SAFFRON and China SACHI trials,
extending clinical value of the all-oral combination
into the 1st-line setting
Results reinforce Tagrisso as the backbone therapy across EGFRm
lung cancer
Positive high-level results from the SANOVO Phase III trial
showed
Tagrisso
(osimertinib) plus
Orpathys
(savolitinib) demonstrated a statistically
significant and highly clinically meaningful improvement in
progression-free survival (PFS) versus
Tagrisso
alone in treatment-naïve patients with
epidermal growth factor receptor-mutated (EGFRm) locally advanced
or metastatic non-small cell lung cancer (NSCLC) and MET
overexpression. The PFS benefit was demonstrated in both the high
MET (IHC 3+) and the intention-to-treat (ITT) trial populations
(IHC 2+, IHC 3+).
In both patient populations, the combination also demonstrated very
encouraging clinical benefit in overall survival (OS), a secondary
endpoint of the trial. The trial will continue to follow up on
these results.
Professor Yi-Long Wu of the Guangdong Provincial People's Hospital,
and the leading principal investigator of the trial, said:
"Co-occurring MET overexpression in treatment-naïve
EGFR-mutated non-small cell lung cancer often compromises the
long-term durability of EGFR-TKI monotherapy. The positive findings
from SANOVO demonstrate that addressing both pathways upfront with
an all-oral, biomarker-directed regimen offers a powerful new
approach for these patients whose tumours have MET overexpression.
By combining
Orpathys
with
Tagrisso
, we have observed a clear clinical benefit that
could reshape primary treatment strategy for this distinct patient
population."
Leora Horn, Senior Vice President, Late Development, Oncology
R&D, AstraZeneca, said: "These positive data from the SANOVO
trial build on the growing body of evidence demonstrating the
benefit of adding
Orpathys
to backbone
Tagrisso
to intercept MET-driven resistance, delay
progression and improve outcomes for these patients. By
developing novel, biomarker-directed combinations that improve upon
established standards of care, AstraZeneca continues to raise the
bar for patients with EGFR-mutated lung
cancer."
Weiguo Su, Chief Executive Officer and Chief Scientific Officer of
HUTCHMED, said: "We are thrilled by the positive results from
SANOVO, which validate our strategy of addressing MET-driven
disease across multiple stages of lung cancer. Building on the
strong foundations of our Phase III SAFFRON global study and SACHI
study in China in pre-treated patients, SANOVO data
further validate the therapeutic strength and versatility of
the
Orpathys
and
Tagrisso
combination in
first-line patients. We are deeply grateful to all patients
and investigators who participated in the trial, and we look
forward to sharing the data with regulatory authorities
to bring this innovative all-oral combination to the
first-line setting in China."
The safety profile for
Tagrisso
plus
Orpathys
was consistent with the known profiles of
each medicine, and there were no new safety findings. These data
will be presented at a forthcoming medical meeting and shared with
regulatory authorities.
Tagrisso
plus
Orpathys
is approved in China for patients with
locally advanced or metastatic EGFRm NSCLC with MET amplification
after disease progression on EGFR-TKI therapy based on the SACHI
Phase III trial. The combination also recently reported
positive high-level results in the
SAFFRON global Phase
III trial
in EGFRm NSCLC
with MET overexpression or amplification after disease progression
on
Tagrisso
, demonstrating a statistically significant and
clinically meaningful improvement in both PFS and
OS.
Orpathys
is being jointly
developed by AstraZeneca and HUTCHMED and commercialised by
AstraZeneca.
Notes
NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death globally,
accounting for almost one in four (23%) cancer
deaths.
1
Lung
cancer is broadly split into NSCLC and small cell lung
cancer,
with
80-85% of patients diagnosed with NSCLC.
2
Approximately
75% of NSCLC patients are diagnosed with advanced
disease.
3
Additionally,
about 10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia, have EGFRm NSCLC.
​4-6
MET is a tyrosine kinase receptor that has an essential role in
normal cell development.
7
MET
overexpression or amplification can lead to tumour growth and the
metastatic progression of cancer cells.
7-8
SANOVO
SANOVO is a blinded, randomized, controlled Phase III trial in
previously untreated patients with locally advanced or metastatic
NSCLC with activating EGFR mutations and MET overexpression in
China conducted by HUTCHMED. The study evaluates the efficacy and
safety of
Orpathys
in combination with
Tagrisso
comparing to
Tagrisso
alone, a standard-of-care treatment option
for these patients. A total of 326 treatment-naïve patients
with locally advanced or metastatic NSCLC harbouring EGFR mutations
(exon 19 deletion or L858R) and MET overexpression were randomized
in a 1:1 ratio to receive
Tagrisso
80mg once daily plus
either
Orpathys
or placebo at 300/200mg twice daily (dosed
based on body weight).
The primary endpoint of the trial is PFS as assessed by
investigators. Other endpoints include PFS assessed by an
independent review committee, OS, objective response rate (ORR),
duration of response (DoR), disease control rate (DCR), time to
response (TTR), and safety.
Orpathys
Orpathys
(savolitinib)
is an oral, potent and highly selective
MET-TKI
that has demonstrated clinical activity in advanced solid tumours.
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
is
approved in China for the treatment of adult patients with locally
advanced or metastatic
NSCLC
with
MET exon 14 skipping alteration,
representing
the
first selective MET inhibitor approved in
China.
Orpathys
also
received a conditional approval in China for the treatment of
patients with locally advanced or metastatic gastric cancer or
gastroesophageal junction adenocarcinoma with MET amplification who
have failed at least two prior systemic
treatments.
Orpathys
in
combination with
Tagrisso
is
approved in China for patients with locally advanced or metastatic
EGFRm-positive non-squamous NSCLC with MET amplification after
disease progression on EGFR-TKI therapy based on the SACHI Phase
III trial.
The
combination was also granted a temporary authorisation in
Switzerland for the treatment of patients with locally advanced or
metastatic EGFRm NSCLC and high levels of MET overexpression or
amplification who progressed on prior treatment
with
Tagrisso.
This
was based on results from the global SAVANNAH Phase II
trial.
Tagrisso
Tagrisso
(osimertinib)
is a third-generation, irreversible EGFR-TKI with proven
clinical activity in NSCLC, including the treatment of central
nervous system metastases.
Tagrisso
(40mg and 80mg QD oral tablets) has been
used to treat more than one million patients across its indications
worldwide and AstraZeneca continues to
explore
Tagrisso
as a treatment for patients across multiple
stages of
EGFRm
NSCLC.
Tagrisso
is approved as monotherapy in
more than
120
countries including the US,
EU,
China
and Japan. Approved indications
include for 1st-line treatment of patients with locally advanced or
metastatic
EGFRm NSCLC, locally advanced or
metastatic
EGFR
T790M mutation-positive NSCLC,
adjuvant treatment of early-stage
EGFRm NSCLC and locally advanced,
unresectable NSCLC following platinum-based chemoradiation
therapy.
Tagrisso
is
also approved in combination with chemotherapy in more than 80
countries, including the US, EU, China and Japan, for 1st-line
treatment of patients with locally advanced or
metastatic
EGFRm NSCLC.
There is an extensive body of evidence supporting the use
of
Tagrisso
in
EGFRm
NSCLC, and it is the only targeted therapy shown to improve patient
outcomes across all stages of the disease.
In late-stage disease,
Tagrisso
demonstrated
improved outcomes as monotherapy in the
FLAURA
Phase
III trial and in combination with chemotherapy in
the
FLAURA2
Phase
III trial.
Tagrisso
is
also being investigated in this setting in combination
with
Datroway
(datopotamab
deruxtecan or Dato-DXd) in the
TROPION-Lung14
and
TROPION-Lung15
Phase
III trials.
Tagrisso
also showed improved outcomes in
early-stage disease in the NeoADAURA and
ADAURA
Phase
III trials and in locally advanced stages in the
LAURA
Phase
III trial. As part of AstraZeneca's ongoing commitment to treating
patients as early as possible in lung cancer,
Tagrisso
is
also being investigated in the early-stage adjuvant resectable
setting in the ADAURA2 Phase III trial.
AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to
cure through the detection and treatment of early-stage disease,
while also pushing the boundaries of science to improve outcomes in
the resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit
most.
The Company's comprehensive portfolio includes leading lung cancer
medicines and the next wave
of
innovations,
including
Tagrisso
and
Iressa
(gefitinib);
Zegfrovy
(sunvozertinib);
Imfinzi
(durvalumab)
and
Imjudo
(tremelimumab);
Enhertu
(trastuzumab
deruxtecan) and
Datroway
in
collaboration with Daiichi Sankyo;
Orpathys
in
collaboration with HUTCHMED; as well as a pipeline of potential new
medicines and combinations across diverse mechanisms of
action.
AstraZeneca is a founding member of the Lung Ambition Alliance, a
global coalition working to accelerate innovation and deliver
meaningful improvements for people with lung cancer, including and
beyond treatment.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition
to provide cures for cancer in every form, following the science to
understand cancer and all its complexities to discover, develop and
deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It
is through persistent innovation that AstraZeneca has built one of
the most diverse portfolios and pipelines in the industry, with the
potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's
innovative medicines are sold in more than 125 countries and
used by millions of patients worldwide. Please
visit
astrazeneca.com
and
follow the Company
on social media
@AstraZeneca
.
Contacts
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.
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.
References
1. World Health Organization.
International Agency for Research on Cancer. Lung Fact Sheet.
Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf
.
Accessed August 2026.
2. American Cancer Society. What Is
Lung Cancer? Available at:
https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html
.
Accessed August 2026.
3. Chen HJ,
et al
. Long-term survival of advanced lung
adenocarcinoma by maintenance chemotherapy followed by
EGFR-TKI.
Medicine
. 2021;100(6):e24688.
4. Szumera-Ciećkiewicz
A,
et
al
. EGFR Mutation Testing
on Cytological and Histological Samples in Non-Small Cell Lung
Cancer: a Polish, Single Institution Study and Systematic Review of
European Incidence.
Int J Clin Exp
Pathol
.
2013;6:2800-2812.
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;29:2121-2127.
6. Ellison G,
et al
. EGFR Mutation Testing in Lung Cancer: a Review
of Available Methods and Their Use for Analysis of Tumour Tissue
and Cytology Samples.
J Clin
Pathol
.
2013;66:79-89.
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.
J Hematol
Oncol
.
2019;63.
Matthew Bowden
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
AstraZeneca
PLC
Date:
01 September 2026
By: /s/
Matthew Bowden
Name:
Matthew Bowden
Title:
Company Secretary