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GSK (NYSE: GSK) highlights positive phase III survival data for licensed SCLC drug

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GSK plc reports that its licensor Hansoh Pharmaceutical Group achieved positive pivotal phase III results for risvutatug rezetecan (Ris-Rez) in advanced or relapsed small-cell lung cancer in a China patient population. The ARTEMIS-008 study met its primary endpoint of overall survival, showing statistically significant and clinically meaningful benefit versus topotecan, with consistent improvements in key secondary endpoints such as progression-free survival and a safety profile in line with prior data.

These data will support Hansoh Pharma's regulatory submission in China. GSK holds exclusive rights to develop and commercialise Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan and is running a broad programme across lung, prostate and other solid tumours, including the global phase III EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung cancer, where pivotal data are expected next year. The company highlights this as the first positive phase III overall survival result for a B7-H3-targeted antibody-drug conjugate in any tumour type.

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Insights

Positive Phase III survival data de-risk GSK’s B7-H3 ADC platform but commercial impact hinges on global trials.

The ARTEMIS-008 trial in China showed that risvutatug rezetecan improved overall survival versus topotecan in advanced or relapsed small-cell lung cancer, with supporting progression-free survival data and a safety profile consistent with earlier studies. This is described as the first positive phase III overall survival result for a B7-H3-targeted antibody-drug conjugate, strengthening the biological rationale for targeting B7-H3 in solid tumours.

For GSK, Hansoh’s success is an external validation of the asset it licenses outside greater China. However, regulatory submission based on ARTEMIS-008 is limited to China, while GSK’s value realization depends on its own global development, including the phase III EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung cancer, with pivotal data expected in 2027. Until those data read out, the news primarily reduces mechanism risk rather than providing immediate revenue visibility.

antibody-drug conjugate medical
"These are the first positive phase III overall survival data reported for a B7-H3-targeted antibody-drug conjugate (ADC)"
An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.
Breakthrough Therapy Designation regulatory
"Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA"
A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.
Orphan Drug Designation regulatory
"Regulatory designations received for Ris-Rez to date include orphan drug designations from the US Food and Drug Administration (FDA)"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Priority Medicines (PRIME) Designation regulatory
"Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC"
A priority medicines (PRIority MEdicines, PRIME) designation is a regulatory label given to a drug candidate that addresses a serious unmet medical need, granting the developer extra scientific guidance and faster review from health authorities. For investors, it signals lower regulatory risk and the potential for quicker approval and market access—think of it as a VIP pass through the approval process that can speed revenue potential and improve the investment outlook.
extensive-stage small-cell lung cancer medical
"including the global phase III EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung cancer (ES-SCLC)"
pulmonary neuroendocrine carcinoma medical
"the European Medicines Agency (EMA) in a category of cancer that includes SCLC, called pulmonary neuroendocrine carcinoma"
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FAQ

What did GSK (GSK) disclose about the ARTEMIS-008 phase III trial?
GSK reported that licensor Hansoh Pharma’s phase III ARTEMIS-008 trial of risvutatug rezetecan in advanced or relapsed small-cell lung cancer met its primary endpoint of overall survival, with statistically significant and clinically meaningful improvement versus topotecan, plus consistent benefits in key secondary endpoints.

How is GSK (GSK) involved with risvutatug rezetecan (Ris-Rez)?
GSK holds exclusive global rights to develop and commercialise Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan. Hansoh Pharma leads development and regulatory filing in China, while GSK runs a broad programme in lung, prostate and other solid tumours internationally.

Why are the ARTEMIS-008 results important for GSK (GSK)?
The ARTEMIS-008 results provide the first positive phase III overall survival data for a B7-H3-targeted antibody-drug conjugate in any tumour type. This supports the therapeutic potential of GSK’s B7-H3 ADC platform and underpins its ongoing global trials, including the EMBOLD SCLC-301 study in extensive-stage small-cell lung cancer.

What regulatory designations has Ris-Rez associated with GSK (GSK) received?
Risvutatug rezetecan has received multiple orphan drug designations in the US, EU and Japan, Priority Medicines (PRIME) Designation from the EMA, and Breakthrough Therapy Designations from the US FDA in relapsed or refractory extensive-stage small-cell lung cancer and osteosarcoma, indicating significant unmet medical need.

What cancer types is GSK (GSK) targeting with Ris-Rez and its oncology strategy?
GSK is developing Ris-Rez across lung cancer, prostate cancer and other solid tumours. More broadly, its oncology ambition is to expand from blood and gynaecologic cancers into lung and gastrointestinal cancers, prioritising programmes like B7-H3 and B7-H4 antibody-drug conjugates and the KIT inhibitor velzatinib.

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 July 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: 10 July 2026, London UK
 
GSK's licensor Hansoh Pharma announces positive phase III results for Ris-Rez in China patient population
 
●       ARTEMIS-008, a phase III study conducted for China, met its primary endpoint of overall survival in advanced or relapsed small-cell lung cancer
●       First positive phase III overall survival data for a B7-H3-targeted ADC in any tumour type
●       GSK is advancing risvutatug rezetecan outside China across multiple tumour types, including lung cancer, prostate cancer and other solid tumours
 
 
GSK plc (LSE/NYSE: GSK) licensor Hansoh Pharmaceutical Group Co., Ltd. today announced that ARTEMIS-008, its pivotal phase III trial evaluating risvutatug rezetecan (Ris-Rez) in patients with advanced or relapsed small-cell lung cancer (SCLC), met its primary endpoint of overall survival (OS). In the trial, conducted in patients in China, Ris-Rez demonstrated statistically significant and clinically meaningful improvements in OS compared with the standard of care, topotecan. Consistent benefit was also observed across key secondary endpoints, including progression-free survival. These data will be used by Hansoh Pharma for regulatory submission in China.
 
These are the first positive phase III overall survival data reported for a B7-H3-targeted antibody-drug conjugate (ADC) in any tumour type. The safety profile is consistent with prior Ris-Rez findings, and no new safety signals were identified.
 
GSK holds exclusive global rights to develop Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan. GSK's broad clinical development programme includes studies in lung cancer, prostate cancer and other solid tumours, including the global phase III EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung cancer (ES-SCLC) with pivotal data expected next year.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said: "These results are an important milestone as the first positive phase III overall survival data for a B7-H3-targeted ADC in any tumour type. Together, with other data generated to date, they further support the potential of B7-H3 as a promising target across lung cancer and other solid tumours and reinforce our continued development of Ris-Rez to improve standard of care in areas of high unmet need."
 
Most patients with ES-SCLC relapse after initial therapy and have limited treatment options, poor prognosis and significant treatment burden.1 B7-H3 is highly expressed in SCLC tumours2,3 and the positive results from ARTEMIS-008 add to the growing body of evidence supporting the encouraging clinical activity and manageable safety profile of Ris-Rez in patients with ES-SCLC.
 
About risvutatug rezetecan
Ris-Rez is a novel investigational B7-H3-targeted ADC composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. 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.
 
Regulatory designations received for Ris-Rez to date include orphan drug designations from the US Food and Drug Administration (FDA) and Japan's Ministry of Health, Labour and Welfare in SCLC and the European Medicines Agency (EMA) in a category of cancer that includes SCLC, called pulmonary neuroendocrine carcinoma; Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC; and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA.4,5,6,7,8,9,10
 
GSK in oncology
Our 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 gynaecologic cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and velzatinib, a highly selective KIT tyrosine kinase inhibitor.
 
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)
 
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)
 
James Dodwell
+44 (0) 20 8047 2406
(London)
 
Mick Readey
+44 (0) 7990 339653
(London)
 
Steph Mountifield
+44 (0) 7796 707505
(London)
 
Sam Piper
+44 (0) 7824 525779
(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 Q1 Results for 2026.
 
Registered in England & Wales:
No. 3888792
 
Registered Office:
79 New Oxford Street
London
WC1A 1DG
 
References
1. G. Mountzios, et al. Tarlatamab in small-cell lung cancer after platinum-based chemotherapy. N Engl J Med, 393 (2025), pp. 349-361. DOI: 10.1056/NEJMoa2502099.
2. A.A. Getu, A. Tigabu, M. Zhou, J. Lu, Ø. Fodstad, M. Tan. New frontiers in immune checkpoint B7-H3 (CD276) research and drug development. Mol. Cancer, 22 (2023), p. 43, 10.1186/s12943-023-01751-9.
3. M. Altan, V. Pelekanou, K.A. Schalper, M. Toki, P. Gaule, K. Syrigos, R.S. Herbst, D.L. Rimm. B7-H3 Expression in NSCLC and Its Association with B7-H4, PD-L1 and Tumor-Infiltrating Lymphocytes. Clin. Cancer Res., 23 (2017), pp. 5202-5209, 10.1158/1078-0432.Ccr-16-3107.
4. 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/.
5. 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/.
6. 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/.
7. 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/.
8. 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/.
9. 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/.
10. 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/.
 
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: July 10, 2026
 
 
 
 
By:/s/ VICTORIA WHYTE
--------------------------
 
 
 
Victoria Whyte
 
Authorised Signatory for and on
 
behalf of GSK plc

Source: View Original Filing on SEC EDGAR