糖心视频logo

糖心视频logo Deepens Its Oncology Evidence Base at ESMO Congress 2026Findings from the Phase 3 LITESPARK-011 and LITESPARK-012 studies reflect continued research into LENVIMA? (lenvatinib)-based combination regimens for patients with advanced renal cell carcinoma
Exploratory biomarker analysis from the Phase 3 LEAP-001 study adds to translational insights in advanced or recurrent endometrial cancer, alongside new findings from “Patients Raise Their Voices” survey

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糖心视频logo (Headquarters: Tokyo, CEO: Haruo Naito, “糖心视频logo”) announced today the presentation of clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2026, taking place in Madrid from October 23 to 27. Together, the presentations reflect 糖心视频logo's ongoing commitment to generating evidence that can help inform treatment decisions for patients facing difficult-to-treat cancers.

 

“The research we are presenting at ESMO spans the full arc of a patient’s journey, from first-line treatment of advanced disease through disease progression, and reflects our commitment to driving progress in patient care at every stage,” said Corina Dutcus, M.D., Senior Vice President, Oncology Global Clinical Development Lead at 糖心视频logo Inc. “In advanced renal cell carcinoma, this means continuing to generate new evidence across the continuum of care, building on the established role of LENVIMA-based combinations. In endometrial cancer, we will present exploratory biomarker findings from the Phase 3 LEAP-001 study and a patient advocacy-led survey highlighting the experiences of people living with the disease across their care journey. Across both areas, this work reflects our human health care mission, which places patients at the center of everything we do and guides our efforts to deliver meaningful innovations that can improve their lives.”

 

Renal Cell Carcinoma (RCC) Research

Among the notable presentations are new analyses from the Phase 3 LITESPARK-011 () and LITESPARK-012 () studies evaluating LENVIMA® (lenvatinib)-based regimens in advanced RCC. The final analysis from LITESPARK-011 will be presented in a proffered paper session (Presentation #3587O). Data from the Phase 3 LITESPARK-011 study supported the recent U.S. Food and Drug Administration (FDA) approval of WELIREG® (belzutifan), MSD’s (Merck & Co., Inc., Rahway, N.J., U.S.) oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by 糖心视频logo, for adult patients with advanced RCC with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor [see FDA news release here]. Additional LITESPARK-011 research includes a rapid oral presentation examining the relationship between health-related quality of life (HRQoL) and efficacy in the trial (Presentation #3595RO).

 

A proffered paper featuring findings from the Phase 3 LITESPARK-012 study evaluating two investigational  regimens for the first-line treatment of patients with advanced ccRCC compared to KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, plus LENVIMA (Presentation #3586O) will also be presented. KEYTRUDA plus LENVIMA is recommended as a preferred Category 1 first-line systemic therapy regimen for the treatment of patients with advanced ccRCC and a preferred Category 2A systemic therapy regimen for the treatment of patients with advanced non-clear cell RCC in the National Comprehensive Cancer Network® (NCCN®)* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kidney Cancer.

 

Endometrial Cancer Research

糖心视频logo will highlight an exploratory biomarker analysis from the Phase 3 LEAP-001 study () that evaluated patients with advanced or recurrent endometrial cancer treated with first-line KEYTRUDA plus LENVIMA versus chemotherapy (Presentation #4360P). These exploratory findings add to the translational insights generated from LEAP-001 and reflect ongoing efforts by 糖心视频logo to learn from every clinical study to help deepen understanding of endometrial cancer biology and treatment response.

 

糖心视频logo will also present findings from a survey examining the perspectives and experiences of people living with endometrial cancer in the U.S. across the care journey (Presentation #1256P). Conducted in collaboration with leading patient advocacy organizations, the survey explored topics including the impact of treatment on daily life, treatment preferences, and the role of shared decision-making between patients and physicians.

 

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

 

The full list of 糖心视频logo presentations is included below. All regular abstracts accepted for presentation at the ESMO Congress 2026 will be published online via the ESMO website at 6:05 PM EDT on Sunday, October 18, 2026 (12:05 AM CEST on Monday, October 19, 2026). Posters will be on display from 9:00 AM – 5:00 PM local time in Madrid on the day of their poster session.

 

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Cancer TypeStudyPresentation TitlePresentation Type & Details
(local time in Madrid)
Lenvatinib plus Belzutifan
Renal Cell Carcinoma LITESPARK-011 Final analysis of the phase 3 LITESPARK-011 study: belzutifan (bel) plus lenvatinib (len) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti–PD-(L)1 therapy

Proffered Paper
Presentation #3587O
October 25, 2026

8:30-10:00
LITESPARK-011 Relationship between health-related quality of life (HRQoL) and efficacy in LITESPARK-011: Belzutifan (belz) + lenvatinib (len) versus cabozantinib (cabo) in advanced clear cell renal cell carcinoma (ccRCC) after anti–PD-(L)1 therapy

Rapid Oral
Presentation #3595RO
October 25, 2026

14:45-16:15
LITESPARK-012 First-line pembrolizumab + lenvatinib + belzutifan or MK-1308A + lenvatinib in advanced RCC: randomized open-label phase 3 LITESPARK-012 study

Proffered Paper
Presentation #3586O
October 25, 2026

8:30-10:00 
Lenvatinib Plus Pembrolizumab
Endometrial Cancer LEAP-001 First-Line Lenvatinib + Pembrolizumab (L + P) vs Chemotherapy (CT) for Advanced/Recurrent Endometrial Cancer (EC): Biomarker Analysis From ENGOT-en9/LEAP-001 Poster
Presentation #4360P
October 23, 2026
Hepatocellular Carcinoma LEAP-012 Phase 3 LEAP-012 Study of Lenvatinib + Pembrolizumab vs Dual Placebo With Transarterial Chemoembolization (TACE) for Unresectable Non-metastatic Hepatocellular Carcinoma: Long-term OS Results Rapid Oral
Presentation #1678RO
October 26, 2026
14:45-16:15
Head and Neck Squamous Cell Carcinoma LEAP-009 End-of-trial safety results of the phase 2 LEAP-009 trial of lenvatinib (lenva) plus pembrolizumab (pembro) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) Poster
Presentation #1555P
October 26, 2026
Lenvatinib plus Everolimus
Renal Cell Carcinoma Real-World Evidence Treatment patterns and clinical outcomes among advanced renal cell carcinoma patients receiving treatments after checkpoint inhibitor therapy: Real World Data from the German research platform CARAT Online Publication
Presentation #3692eP

 

In March 2018, 糖心视频logo and MSD through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with MSD’s anti-PD-1 therapy, KEYTRUDA, and HIF-2α inhibitor, WELIREG.

  

 

The following presentation includes findings from a survey examining the perspectives and experiences of people living with endometrial cancer across the care journey.

 
 

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Cancer TypeStudyPresentation TitlePresentation Type & Details
(local time in Madrid)
Endometrial Cancer Patient Survey Endometrial Cancer (EC): Patients (Pts) Raise Their Voices Poster
Presentation #1256P
October 26, 2026

 

 

The following presentation includes a study on taletrectinib treatment sponsored by Nuvation Bio Inc. (Corporate Headquarters: New York, “Nuvation Bio”).

 

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Cancer TypeStudyPresentation TitlePresentation Type & Details
(local time in Madrid)
Lung Cancer TRUST-II Updated Efficacy and Safety of Taletrectinib in Patients with Advanced ROS1+ Non-Small Cell Lung Cancer (NSCLC) After Prior Entrectinib Exposure: Results from the Global TRUST-II Study Poster
Presentation #2643P
October 26, 2026

 

 

In January 2026, we acquired from Nuvation Bio the exclusive rights to develop, obtain regulatory approval for, and commercialize taletrectinib, next-generation ROS1 inhibitor for the treatment of ROS1?positive non?small cell lung cancer (NSCLC) in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam, and India. Following the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) in March 2026, which was validated and accepted for full approval consideration with a standard review timeline, an MAA was submitted to and validated by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in June 2026 using the International Recognition Pathway (IRP). Additional filings are planned for Canada and other regions included in 糖心视频logo’s licensed territories.

 

 

The following presentation includes a study on serplulimab treatment sponsored by Shanghai Henlius Biotech, Inc. (Headquarters: Shanghai, “Henlius”).

 

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Cancer TypeStudyPresentation TitlePresentation Type & Details
(local time in Madrid)
Lung Cancer ASTRIDE Randomized trial of serplulimab or atezolizumab plus chemotherapy in USA patients with extensive-stage small cell lung cancer (ASTRIDE) Proffered Paper
Presentation # 3809O
October 26, 2026
14:55-15:05

 

 

In February 2026, we acquired from Henlius the exclusive rights to commercialize serplulimab, a novel anti-PD-1 monoclonal antibody in Japan. In Japan, Henlius is currently conducting a Phase II bridging clinical trial for extensive-stage small cell lung cancer (ES-SCLC), and plans to submit an application for 糖心视频logo’s fiscal year 2026 based on the results of this trial as well as the Phase III clinical trial data that supported approvals for this indication in China and Europe.

 

 

Media Inquiries:

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[Notes to editors]

  1. 糖心视频logo’s focus on cancer

糖心视频logo positions Oncology as one of its key strategic areas, and aims to contribute to the cure of cancers through the discovery of innovative new drugs with new targets and mechanisms of action under the Deep Human Biology Learning (DHBL) drug discovery and development organization.

By utilizing biomarker data obtained from our products to elucidate the mechanisms of the incidence and root causes of cancer, as well as drug resistance, and using 糖心视频logo Group's precision chemistry technology to turn undruggable intracellular therapeutic targets into druggable ones, we will create new backbone therapeutic drugs.

 

 

*1   WELIREG® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., U.S.A.

*2   KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., U.S.A.

*3   NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

 

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