GSK在ESMO公布Ris-Rez全球首个小细胞肺癌Ib期数据：8mg/kg剂量ORR 61%，为对翰森中国III期阳性数据的增量确认

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6-K
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a4743z.htm
RIS-REZ POSITIVE EARLY DATA IN LUNG CANCER
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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 October 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: 18 October 2026, London UK
GSK presents first global data for Ris-Rez in extensive-stage small
cell lung cancer
●
61%
overall response rate in phase Ib trial
●
Results
build on positive pivotal data in Chinese patients
●
Data
supports accelerated Ris-Rez development, including in ongoing
global phase III trial in ES-SCLC
GSK plc (LSE/NYSE: GSK) today announced the first global data for
risvutatug rezetecan (Ris-Rez), its investigational B7-H3-targeted
antibody-drug conjugate (ADC), in patients with relapsed
extensive-stage small cell lung cancer (ES-SCLC). Results from the
phase Ib dose-optimisation portion of the EMBOLD PanTumour-101
trial showed positive anti-tumour activity and a manageable safety
profile, adding to recently reported positive phase III data in
patients with SCLC in China.
1
In the trial, Ris-Rez achieved a confirmed objective response rate
(ORR) of 61% among evaluable patients at the 8 mg/kg dose (n=11/18;
95% CI: 35.7-82.7), compared with 32% at the 6 mg/kg dose (n=7/22;
95% CI: 13.9-54.9). These findings will be presented in a poster
session at the European Society for Medical Oncology (ESMO)
Congress 2026 in Madrid, Spain. Along with data from Hansoh’s
phase III ARTEMIS-008 study in SCLC, this data supported selection
of the 8 mg/kg dose currently being evaluated in GSK’s global
phase III EMBOLD SCLC-301 study.
Hesham Abdullah, Senior Vice President, Global Head of Oncology,
R&D, GSK said
, “Today’s first global data for
Ris-Rez build on the statistically significant overall survival
benefit recently reported in Hansoh’s pivotal Chinese trial.
As the data for Ris-Rez continues to grow, we remain focused on
accelerating development in extensive-stage small cell lung cancer,
where patients often relapse quickly and urgently need more
treatment options.”
The safety profile was manageable across both dose levels at a
median follow-up of 100.5 days. Grade 3 or higher treatment-related
adverse events (TRAEs) were observed in 42% of patients receiving 8
mg/kg and 15% of those receiving 6 mg/kg, with haematological
events being the most common. The overall rate of interstitial lung
disease (ILD) was low (2%; 1 out of 50 patients) and the case was
moderate (grade 2).
Hye Ryun Kim, MD, PhD, Division of Medical Oncology, Yonsei Cancer
Center, and a study investigator in the EMBOLD PanTumour-101 study,
said,
“Extensive-stage
small cell lung cancer remains one of the most aggressive cancers
we treat, with five-year survival rates typically in the single
digits. Patients whose disease relapses often have limited options,
and current therapies can be difficult to tolerate. The response
rates and manageable safety profile observed with Riz-Rez are
encouraging and support its ongoing development in this
setting.”
These data will be presented alongside a broader set of findings
from the EMBOLD programme at ESMO 2026, including global
dose-escalation results from EMBOLD PanTumour-101, an analysis of
ILD across the Ris-Rez early clinical programme, and the design of
the global phase III EMBOLD SCLC-301 study. Real-world evidence
from the RESONANCE study further demonstrates the complexity of
treatment decision-making after relapse in ES-SCLC and highlights
the absence of a clear treatment standard in later lines of
therapy. Together, these findings contribute to the growing body of
evidence for Ris-Rez and reflect GSK’s focus on advancing
targeted medicines where significant patient need and scientific
opportunity remain.
About EMBOLD PanTumour-101
EMBOLD PanTumour-101 (NCT06551142) is a global, open-label phase
Ia/b study evaluating the safety, tolerability and clinical
activity of Ris-Rez monotherapy in adult patients with advanced or
metastatic solid tumours. In the phase Ib dose-optimisation portion
of the study, patients with relapsed (2L+) extensive-stage small
cell lung cancer were randomised to receive Ris-Rez 6 mg/kg or 8
mg/kg intravenously every three weeks until disease progression,
unacceptable toxicity, loss to follow-up or death. The analysis
presented at ESMO 2026 included 50 patients who had received a
median of two prior therapies. The study population included
patients with prior topoisomerase-1 inhibitor or tarlatamab
exposure, as well as patients with brain or liver metastases.
Enrolment in the phase Ib dose-optimisation portion of the trial
was still ongoing at data cut-off, and longer follow-up will be
needed to further characterise the durability of
response.
About risvutatug rezetecan
Ris-Rez is a novel investigational antibody-drug conjugate
targeting the B7-H3 protein, which is highly expressed in more than
10 solid tumour types, supporting GSK’s ambition to develop
it across more than 40 indications by 2040. GSK acquired exclusive
worldwide rights (excluding China’s mainland, Hong Kong,
Macau, and Taiwan) from Hansoh Pharma to progress clinical
development and commercialisation of Ris-Rez. More than 1,000
patients have received Ris-Rez as part of GSK’s global EMBOLD
clinical trial programme, which includes phase III trials in
late-line extensive-stage small cell lung cancer (ES-SCLC) and
metastatic castration-resistant prostate cancer (mCRPC), with
additional upcoming phase III trials planned in early-line SCLC and
chemo-naïve mCRPC. Ris-Rez has received several global
regulatory designations to date, including orphan drug designations
in the US, Japan and the EU for SCLC, and Breakthrough Therapy
Designation in the US and Priority Medicines (PRIME) Designation
from the EMA for relapsed or refractory ES-SCLC, among
others.
2,3,4,5,6
About small cell lung cancer
Small cell lung cancer (SCLC) is associated with rapid progression
and accounts for approximately 10-15% of all lung cancer diagnoses
worldwide.
7
SCLC is characterised by early
metastatic spread, frequent relapse and poor
prognosis.
7
Approximately 70% of patients with
SCLC are diagnosed with extensive-stage disease (ES-SCLC), meaning
the cancer has spread throughout one or both lungs and/or to other
parts of the body.
7,8
Median overall survival for patients
with ES-SCLC treated with current standard-of-care therapies is
approximately 12 to 13 months.
8
Despite advances in treatment,
outcomes for patients with ES-SCLC remain poor and risk of disease
progression or recurrence remains high, underscoring the need for
new therapies that can improve outcomes for patients facing this
aggressive cancer.
About GSK in oncology
GSK is focused on developing differentiated medicines for cancers
where patients continue to face poor outcomes, treatment
resistance, limited options or significant treatment burden. We
focus where advances in science and technology offer the greatest
opportunity to improve outcomes across haematological, lung,
gastrointestinal, genitourinary and gynaecological cancers. Across
multiple modalities, including targeted small molecules,
antibody-drug conjugates (ADCs) and immunotherapies, GSK applies
deep expertise in cancer biology and immune system science to
develop differentiated medicines designed to deliver durable
responses, overcome resistance and reduce treatment
burden.
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)
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(London)
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(London)
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+1 202 603 5003
(Washington DC)
Alison Hunt
+1 540 742 3391
(Washington DC)
Investor Relations:
James Dodwell
+44 (0) 7881 269066
(London)
Mick Readey
+44 (0) 7990 339653
(London)
Joanna Tuplin
+44 (0) 7788 351650
(London)
Sam Piper
+44 (0) 7824 525779
(London)
Dan Smith
+44 (0) 7823 523885
(London)
Jeff McLaughlin
+1 215 751 7002
(Philadelphia)
Frannie DeFranco
+1 215 751 3126
(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.
GSK.
Ris-Rez reduced risk of death by 54% versus topotecan in patients
with relapsed small cell lung cancer in China.
https://www.gsk.com/en-gb/media/press-releases/ris-rez-reduced-risk-of-death-by-54-versus-topotecan-in-patients-with-relapsed-small-cell-lung-cancer-in-china/
2.
GSK.
GSK receives US FDA Breakthrough Therapy Designation for its
B7-H3-targeted antibody-drug conjugate in relapsed or refractory
extensive-stage small-cell lung cancer. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/.
3.
GSK.
GSK’s B7-H3-targeted antibody-drug conjugate, risvutatug
rezetecan, granted Orphan Drug Designation for small-cell lung
cancer in Japan. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-risvutatug-rezetecan-granted-orphan-drug-designation-for-small-cell-lung-cancer-in-japan/.
4.
GSK.
GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227,
receives EMA Priority Medicines (PRIME) Designation in relapsed
extensive-stage small-cell lung cancer. Available at:
https://www.gsk.com/en-gb/media/press-releases/b7-h3-targeted-antibody-drug-conjugate-receives-ema-priority-medicines-designation-in-relapsed-extensive-stage-small-cell-lung-cancer/.
5.
GSK.
GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227,
receives Orphan Drug Designation in the EU. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-gsk-227-receives-orphan-drug-designation-in-the-eu
6.
GSK.
GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227,
receives US FDA Breakthrough Therapy Designation in late-line
relapsed or refractory osteosarcoma. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-b7-h3-targeted-antibody-drug-conjugate-gsk227-receives-us-fda-breakthrough-therapy-designation-in-late-line-relapsed-or-refractory-osteosarcoma/.
7.
Kim S, Park H, Chiang A.
Small Cell Lung Cancer: A
Review
. JAMA.
2025.
8.
Saida Y, Watanabe S, Kikuchi T.
Extensive-Stage
Small-Cell Lung Cancer: Current Landscape and Future
Prospects
. Onco Targets Ther.
2023.
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: October
19, 2026
By:/s/ VICTORIA
WHYTE
--------------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GSK plc