GSK 在 WCLC 2026 公布 Jideytro(zidesamtinib) 一线 ROS1 阳性 NSCLC 注册性阳性数据(ORR 94%)，计划年内提交 sNDA

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6-K
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JIDEYTRO POSITIVE DATA FOR ROS1-POSITIVE NSCLC
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of September 2026
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 14 September 2026, London UK
GSK presents positive registrational
data to potentially expand
Jideytro
(zidesamtinib) to first-line ROS1-positive
non-small cell lung cancer
●
94%
objective response rate at 15.2 months follow-up
●
90%
of patients were progression free at 12 months, with median PFS
rate still to be reached
●
70%
of patients with measurable brain metastases achieved complete
clearance of detectable brain tumours
●
Results
support potential to address key efficacy and tolerability needs in
ROS1-positive NSCLC with US regulatory submission planned in
2026
GSK plc (LSE/NYSE: GSK) today announced positive results from the
registrational phase I/II ARROS-1 trial
evaluating
Jideytro
(zidesamtinib) in patients with advanced or
metastatic ROS1-positive non-small cell lung cancer (NSCLC) who had
not received previous treatment with a tyrosine kinase inhibitor
(TKI-naïve). The data were presented in a Presidential
Symposium session at the 2026 World Conference on Lung Cancer
(WCLC) in Seoul, South Korea, and will support a planned
supplemental New Drug Application to the US FDA this year to expand
the indication for
Jideytro
to include first-line
treatment.
In the 94 TKI-naïve patients included in the analysis,
zidesamtinib achieved a clinically meaningful 94% objective
response rate (ORR) (88/94; 95% CI: 87-98), including a 15%
complete response rate (14/94), after a median follow-up of 15.2
months (range 1.1–30.5). Responses were durable, with 94% of
patients continuing to respond to treatment at nine months and 86%
at 12 months. Progression-free survival (PFS) was 90% at 12 months.
Median duration of response (DOR) and median PFS had not been
reached at the time of analysis.
In
the trial, 100% of patients with measurable brain metastases at
baseline (n=10) responded to zidesamtinib (10/10, 95% CI:
69–100), and 70% achieved a complete clearance of detectable
brain tumours (7/10). At 12 months, 78% of patients maintained an
intracranial response, and no central nervous system progression
events were observed among patients without brain metastases at
baseline.
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Hesham Abdullah, Senior Vice President, Global Head of Oncology,
R&D, GSK said,
“Today’s results show a combination of
high response rates and a tolerability profile that helped most
patients stay on treatment. They highlight the potential for a
differentiated profile for zidesamtinib to become a first-line
treatment for patients with ROS1-positive NSCLC – a condition
where maintaining long-term disease control, managing spread to the
brain and minimising treatment-related side effects remain key
challenges. We look forward to sharing these data with
regulators.”
Low rates of treatment discontinuation were observed, consistent
with previous safety reports for zidesamtinib. The most common
(≥15%) treatment-related adverse events (TRAEs) were
peripheral oedema, weight increase, blood creatine phosphokinase
increase, dysgeusia and aspartate aminotransferase increase; most
were low grade. TRAEs led to dose reductions in 11% of patients and
discontinuation in 1%.
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Alexander Drilon, MD, ARROS-1 primary investigator and Chief of the
Early Drug Development Service at Memorial Sloan Kettering Cancer
Center, said:
“Patients with ROS1-positive NSCLC may
receive treatment for many years while continuing to work, care for
their families and live their daily lives. They need treatments
that provide lasting control of their disease, including in the
brain, while limiting side effects and treatment disruption. The
durable responses and low rates of treatment discontinuation
observed in ARROS-1 represent encouraging progress toward
addressing these long-term treatment
needs.”
Zidesamtinib is not approved anywhere in the world for use as
first-line therapy. In July 2026, the FDA approved zidesamtinib for
patients with ROS1-positive NSCLC previously treated with a
TKI.
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About ARROS-1
The global, single-arm, first-in-human phase I/II ARROS-1 study
(NCT05118789) included a phase II cohort of patients with locally
advanced or metastatic ROS1-positive NSCLC who were naïve to
ROS1 tyrosine kinase inhibitor (TKI) therapy, with up to one prior
line of chemotherapy and/or immunotherapy permitted. Of 532
patients with ROS1-positive NSCLC who received zidesamtinib 100 mg
once daily across all lines of therapy, 183 were receiving their
first TKI-targeted treatment. The efficacy-evaluable population
(n=94) included patients with measurable disease (by blinded
independent central review) who initiated treatment by 15 June
2025, to allow at least nine months of follow-up for duration of
response. 27% had received prior chemotherapy, 17% of whom also had
prior immunotherapy. 17% had baseline central nervous system
metastases by BICR. Data cut-off was 16 April 2026.
About ROS1-positive NSCLC
ROS1 mutations occur in approximately 2% of non-small cell lung
cancers, contributing to an estimated 50,000 new diagnoses
worldwide each year, typically in younger patients and more often
in non-smokers. The disease has a high propensity to spread to the
central nervous system, with brain metastases present in up to 40%
of patients at diagnosis and remaining a common site of disease
progression during treatment. Despite advances in targeted
therapies, unmet need remains due to challenges including central
nervous system progression, acquired resistance and treatment
tolerability.
3-6
About
Jideytro
Jideytro
(zidesamtinib),
part of GSK’s portfolio from the recently completed
acquisition of Nuvalent, Inc.
7
,
was designed as a ROS1 TKI with broad coverage of ROS1 resistance
mutations, activity against disease that has spread to the brain,
durable treatment responses and a tolerable profile. Together,
these features aim to help patients maintain disease control for
longer while reducing the treatment challenges that can emerge over
time.
Jideytro
is FDA approved
for the treatment of adult patients with locally advanced or
metastatic ROS1-positive non-small cell lung cancer (NSCLC) who
received a prior ROS1 TKI.
The US Prescribing Information is
available
here
.
8
GSK in oncology
GSK’s ambition in oncology is to help increase overall
quality of life, maximise survival and change the course of
disease, expanding from our current focus on blood and
women’s cancers into lung and gastrointestinal cancers, as
well as other solid tumours. This includes accelerating priority
programmes such as antibody-drug conjugates Ris-Rez targeting B7-H3
and Mo-Rez targeting B7-H4, and velzatinib, a highly selective KIT
tyrosine kinase inhibitor.
GSK’s focus in lung cancer is to develop medicines that can
deliver durable responses, overcoming resistance and reducing
treatment burden across small cell and non-small cell lung cancers.
GSK’s lung cancer portfolio is built on validated targets and
modalities where we have growing expertise, including targeted
small molecules and ADCs. This approach allows us to match the
right therapeutic modality to the right target, tumour type and
patient need – with the bold ambition to launch multiple new
options in lung cancer over the next five years.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at
www.gsk.com
.
GSK enquiries
Media:
Tim Foley
+44 (0) 20 8047 5502
(London)
Sarah Clements
+44 (0) 20 8047 5502
(London)
Madison Goring
+44 (0) 20 8047 5502
(London)
Kathleen Quinn
+1 202 603 5003
(Washington DC)
Alison Hunt
+1 540 742 3391
(Washington DC)
Investor Relations:
Constantin Fest
+44 (0) 7831 826525
(London)
Joanna Tuplin
+44 (0) 7788 351650
(London)
James Dodwell
+44 (0) 7881 269066
(London)
Mick Readey
+44 (0) 7990 339653
(London)
Sam Piper
+44 (0) 7824 525779
(London)
Dan Smith
+44 (0) 7823 523885
(London)
Jeff McLaughlin
+1 215 751 7002
(Philadelphia)
Cautionary statement regarding forward-looking
statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described in the “Risk
Factors” section in GSK’s Annual Report on Form 20-F
for 2025, and GSK’s Q2 Results for 2026.
Registered in England & Wales:
No. 3888792
Registered Office:
79 New Oxford Street
London
WC1A 1DG
References
1.
Drilon
A, et al. Zidesamtinib in TKI-naive patients with
advanced/metastatic ROS1+ NSCLC: ARROS-1 efficacy and safety data.
Presented at: 2026 World Conference on Lung Cancer (WCLC); 12-15
September 2026; Seoul, South Korea.
2.
GSK
press release issued 22 July 2026: Jideytro (zidesamtinib) approved
in the US for previously treated ROS1-positive non-small cell lung
cancer.
3.
Ou
SI, Zhu VW. Rearranged rules: ROS1 fusions in lung cancer. Lung
Cancer. 2019;130:201-207.
4.
Patil
T, Smith DE, Bunn PA Jr, et al. The Incidence of Brain Metastases
in Stage IV ROS1-Rearranged Non-Small Cell Lung Cancer and Rate of
Central Nervous System Progression on Crizotinib. J Thorac Oncol.
2018;13(11):1717-1726.
5.
Gainor
JF, Tseng D, Yoda S, et al. Patterns of Metastatic Spread and
Mechanisms of Resistance to Crizotinib in ROS1-Positive
Non-Small-Cell Lung Cancer. JCO Precis Oncol.
2017;2017:PO.17.00063.
6.
Drilon
A, Somwar R, Wagner JP, et al. A Novel Crizotinib-Resistant
Solvent-Front Mutation Responsive to Cabozantinib Therapy in a
Patient with ROS1-Rearranged Lung Cancer. Cancer Discov.
2017;7(4):400-409.
7.
GSK
press release issued 15 July 2026: GSK completes acquisition of
Nuvalent, Inc.
8.
Jideytro
(zidesamtinib) US Prescribing Information.
Memorial Sloan Kettering Cancer Center Disclosure: Dr. Drilon has
financial interests related to Nuvalent, Inc.
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 authorised.
GSK plc
(Registrant)
Date: September
14, 2026
By:/s/ VICTORIA
WHYTE
--------------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GSK plc