GSK showcases pipeline momentum across lung, gynaecological and gastrointestinal cancers at ESMO 2026

16 October 2026

Issued: London, UK

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First global Ris-Rez data to show positive anti-tumour activity in relapsed extensive-stage small-cell lung cancer

Late-breaking Mo-Rez data will demonstrate clinically meaningful and durable activity in platinum-resistant ovarian cancer

AZUR-1 data to show clinically meaningful sustained complete responses with Jemperli (dostarlimab) in MSI-H/dMMR locally advanced rectal cancer

GSK plc (LSE/NYSE: GSK) will present more than 20 abstracts from its expanding solid tumour portfolio at the 2026 European Society for Medical Oncology (ESMO) Congress (23-27 October) in Madrid, Spain. Presentations across lung, gynaecological and gastrointestinal cancers include new investigational data for risvutatug rezetecan (Ris-Rez), mocertatug rezetecan (Mo-Rez) and Jemperli (dostarlimab).

Key presentations include:

Ris-Rez in extensive-stage small-cell lung cancer (ES-SCLC): Results from the first global phase I/II EMBOLD PanTumor-101 trial will show positive anti-tumour activity and manageable tolerability at the dose selected for phase III. Together with positive phase III data previously reported in China, the findings support the potential of Ris-Rez to address limited treatment options and poor outcomes for patients with relapsed ES-SCLC. (Abstracts #1071P, #3841P).

Ris-Rez in osteosarcoma: GSK’s licensor Hansoh Pharma will present detailed late-breaking phase III ARTEMIS-011 data evaluating Ris-Rez in osteosarcoma. This follows positive topline results announced earlier this year and adds to the body of evidence across multiple difficult-to-treat tumour types (Abstract #LBA9).

Mo-Rez in platinum-resistant ovarian cancer (PROC): Late-breaking 13-month follow-up data from the phase I BEHOLD-1 study will demonstrate clinically meaningful, durable responses and encouraging progression-free survival data for Mo-Rez in platinum-resistant ovarian cancer, alongside tolerability data, supporting its potential as a differentiated B7-H4-targeted treatment. (Abstract #LBA41).

Jemperli in rectal cancer: Results from the registrational phase II AZUR-1 trial evaluating Jemperli (dostarlimab) in adults with MSI-H/dMMR locally advanced rectal cancer will be presented during a late-breaking oral session. The analysis includes clinically meaningful data on sustained clinical complete responses. (Abstract #LBA87).

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The data we are presenting at ESMO reflect our progress across some of the most difficult-to-treat cancers. From lung and gynaecological cancers to gastrointestinal tumours, we are building a portfolio of differentiated medicines designed to deliver deep and durable responses, overcome resistance and reduce treatment burden.”

Full list of GSK’s presentations at ESMO:

Ris-Rez

Mo-Rez

Jemperli (dostarlimab)

Velzatinib (IDRX-42)

Zejula (niraparib)

GSK5471713

GSK5533524

CD226

Full list of Alliance studies at ESMO:

About lung cancer

Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide, with approximately 2.5 million new cases and 1.88 million deaths annually. 1 Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases, while small cell lung cancer (SCLC) is less common but typically more aggressive. 1 Despite advances in treatment, lung cancer is often diagnosed at an advanced stage, when prognosis is poor and risk of disease progression or recurrence is high. 1 Extensive-stage SCLC (ES-SCLC) represents the majority of SCLC diagnoses, with most patients presenting after the disease has spread beyond the lungs. 2

About ovarian cancer and endometrial cancer

Endometrial cancer affects 1.6 million people globally, with 417,000 new cases each year and 15% to 20% of patients presenting in later stages of the disease. 3,4 Ovarian cancer affects 843,000 people with 240,000 new cases annually. 5 70% of these patients present with advanced disease. 6 Recurrence is common in advanced cases of disease, up to 67% in endometrial cancer and 70% in ovarian cancer, and survival usually declines after recurrence. 7,8

About stage II/III dMMR/MSI-H locally advanced rectal cancer

Around 5–10% of rectal cancers are mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H). 9 These tumours have a specific genetic characteristic where they are unable to properly repair DNA damage, leading to an accumulation of mutations. This unique biological feature often makes them responsive to immunotherapies. 10, 11 These biomarkers are most commonly found in colorectal, endometrial and other gastrointestinal cancers, but can also be present in other solid tumours. 12

About GIST

Gastrointestinal stromal tumours (GIST) are the most common subtype of soft tissue sarcoma, with about 80,000 to 120,000 patients diagnosed with GIST per year worldwide. 13 GIST typically presents in the gastrointestinal tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation and survival of tumour cells (primary or activating mutations in exons 9 and 11). 14 Additionally, about 90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations in exons 13 and 17) that typically lead to relapse with limited therapeutic options. 15 There are currently no approved tyrosine kinase inhibitors (TKIs) that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT.

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. 16, 17, 18, 19, 20, 21 , 22

About mocertatug rezetecan

Mo-Rez is a novel investigational B7-H4-targeted antibody-drug conjugate designed to optimise efficacy and tolerability. It is composed of a fully human anti-B7-H4 monoclonal antibody covalently linked to a topoisomerase inhibitor payload and has a drug-to-antibody ratio (DAR) of 6. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Mo-Rez globally.

About dostarlimab

Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, plays an important role in GSK’s immune-oncology research and development programme. A clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal, and head and neck cancers.

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation and manufacturing of Jemperli.

More information about the product and its currently approved indications is available at EU product information and US product information.

About velzatinib

Velzatinib is a highly selective, investigational small molecule tyrosine kinase inhibitor (TKI) designed to target all key KIT mutations in GIST. The US Food and Drug Administration (FDA) has granted velzatinib Fast Track designation for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and Orphan Drug designations for the treatment of GIST.

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 .

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.

References

World Health Organization. Lung cancer Fact Sheet. Updated April 2026. Available at: https://www.who.int/news-room/fact-sheets/detail/lung-cancer

Kim S, Park H, Chiang A. Small Cell Lung Cancer: A Review. JAMA. 2025;333(21):1906-1917.

Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660.

CMP: CancerMPact® Patient Metrics Mar-2023, Cerner Enviza.

Ren Y, Xu R, Wang Y, Su L, Su J. Global, regional, and national burden of ovarian cancer in women aged 45 + from 1990 to 2021 and projections for 2050: a systematic analysis based on the 2021 global burden of disease study. J Cancer Res Clin Oncol. 151(8):225. doi:10.1007/s00432-025-06277-9.

Rauh-Hain JA, Krivak TC, Del Carmen MG et al. Ovarian cancer screening and early detection in the general population. Rev Obstet Gynecol. 2011;4(1):15-21.

Shelvin KB, Vincent J, Morron S, Morin M, Mammoser A, Nair N. Recurrent high grade serous endometrial cancer with brain metastases: Immunotherapy confers improved quality of life and survival. Gynecol Oncol Rep. 2024;55:101494. doi:10.1016/j.gore.2024.101494.

Salas Bolívar P, Gonzalez-Benitez C, Carbonell López M, Díez Sebastian J, Hernández Gutiérrez A, Zapardiel I. Prognostic Factors After the First Recurrence of Ovarian Cancer. Journal of Clinical Medicine. 2025; 14(2):470. https://doi.org/10.3390/jcm14020470 .

Cercek A, et al. Mismatch Repair-Deficient Rectal Cancer and Resistance to Neoadjuvant Chemotherapy. Clin Cancer Res. 2020 Jul 1;26(13):3271-3279. doi: 1158/1078-0432.CCR-19-3728. Epub 2020 Mar 6. PMID: 32144135; PMCID: PMC7348681

Le DT, et al. PD-1 blockade in tumors with mismatch repair deficiency. N Engl J Med. 2015;372(26):2509-2520.

Andre T, Berton D, Curigliano G, et al. Antitumor Activity and Safety of Dostarlimab Monotherapy in Patients With Mismatch Repair Deficient Solid Tumors: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023;6(11):e2341165. doi:10.1001/jamanetworkopen.2023.41165.

National Cancer Institute at the National Institutes of Health. Definition of mismatch repair deficiency. Accessed June 2026. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mismatch-repair-deficiency

Søreide K, Sandvik OM, Søreide JA, Giljaca V, Jureckova A, Bulusu VR. Global epidemiology of gastrointestinal stromal tumours (GIST): A systematic review of population-based cohort studies. Cancer Epidemiol. 2016 Feb;40:39-46.

Bauer S, George S, von Mehren M, Heinrich MC. Early and Next-Generation KIT/PDGFRA Kinase Inhibitors and the Future of Treatment for Advanced Gastrointestinal Stromal Tumor. Front Oncol. 2021 Jul 12;11:672500.

Zhou S, Abdihamid O, Tan F, Zhou H, Liu H, Li Z, Xiao S, Li B. KIT mutations and expression: current knowledge and new insights for overcoming IM resistance in GIST. Cell Commun Signal. 2024 Feb 27;22(1):153.

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/ .

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/ .

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/ .

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

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/ .

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/ .

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/ .