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European Commission Approves KEYTRUDA® (pembrolizumab) as Part of a Treatment Regimen for Adults with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) Expressing PD-L1 (CPS >1)

On October 29, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the European Commission (EC) has approved KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1. This approval marks the first and only anti-PD-1 treatment option for certain patients with resectable LA-HNSCC in the European Union (EU) and the third approval for KEYTRUDA in HNSCC in the EU.

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"This approval brings a promising advancement to patients in Europe with resectable locally advanced head and neck squamous cell carcinoma," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We’re proud of the continued progress we’re making to broaden the impact of KEYTRUDA in head and neck cancers and remain focused on working to deliver innovative approaches that have the potential to make a meaningful difference for patients."

The EC approval is based on results from the pivotal Phase 3 KEYNOTE-689 trial. At the trial’s first pre-specified interim analysis, the KEYTRUDA-based perioperative regimen demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, compared to adjuvant radiotherapy (with or without cisplatin) alone in patients with tumors expressing PD-L1 (CPS ≥1). The KEYTRUDA-based perioperative regimen reduced the risk of EFS events (defined as disease recurrence, disease progression or death) by 30% (HR=0.70 [95% CI, 0.55-0.89]; p=0.00140) in patients with tumors expressing PD-L1 (CPS ≥1) compared to adjuvant radiotherapy (with or without cisplatin) alone. Among the patients with tumors expressing PD-L1 (CPS ≥1), median EFS was doubled to 59.7 months (95% CI, 37.9-not reached) in the KEYTRUDA arm versus 29.6 months (95% CI, 19.5-41.9) in the comparator arm. The approval follows the positive recommendation from the Committee for Medicinal Products for Human Use received in September 2025.

This approval allows marketing of this KEYTRUDA treatment regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Timing for commercial availability of KEYTRUDA for this indication in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures.

In June 2025, KEYTRUDA was approved in the U.S. for the treatment of adult patients with resectable LA-HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by a U.S. Food and Drug Administration (FDA)-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin and then as a single agent. Based on the results from the Phase 3 KEYNOTE-689 trial KEYTRUDA was also approved in Canada, Brazil, Switzerland and several other countries around the globe as a perioperative treatment option for certain patients with resectable LA-HNSCC.

About KEYNOTE-689

KEYNOTE-689 is a randomized, active-controlled, open-label Phase 3 trial (ClinicalTrials.gov, NCT03765918) evaluating KEYTRUDA as neoadjuvant treatment and KEYTRUDA in combination with standard of care radiotherapy (with or without cisplatin) as adjuvant treatment in treatment-naïve patients with newly diagnosed, stage III or IVA resectable LA-HNSCC. Efficacy outcomes are classified by PD-L1 status. The primary endpoint is EFS, which is defined as the time from randomization to the first occurrence of radiographic disease progression; local or distant progression or recurrence; or death due to any cause. The secondary endpoints include overall survival, major pathological response, pathological complete response and safety. The study enrolled 714 patients who were randomized 1:1 to receive:

KEYTRUDA (200 mg intravenously [IV] every three weeks [Q3W] for two cycles) as neoadjuvant therapy prior to surgery, followed by either KEYTRUDA (200 mg IV Q3W for 15 cycles) plus standard of care radiotherapy with cisplatin (100 mg/m2 IV Q3W for three cycles) as adjuvant therapy following surgery for high-risk patients or KEYTRUDA (200 mg IV Q3W for 15 cycles) plus standard of care radiotherapy without cisplatin as adjuvant therapy following surgery for low-risk patients; or
No neoadjuvant therapy prior to surgery, followed by adjuvant standard of care radiotherapy with cisplatin (100 mg/m2 IV Q3W for three cycles) as adjuvant therapy following surgery for high-risk patients or standard of care radiotherapy without cisplatin as adjuvant therapy following surgery for low-risk patients.
About head and neck cancer

Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. It is estimated there were more than 947,200 new cases of head and neck cancer diagnosed and more than 482,400 deaths from the disease in 2022 globally. In Europe, it is estimated there were approximately 161,900 new cases of head and neck cancer and more than 72,500 deaths from the disease in 2022. These data include cancers of the oral cavity, pharynx and larynx. Most head and neck cancers are squamous cell carcinomas, which begin in the flat, squamous cells that make up the thin mucosal lining of the head and neck. Locally advanced head and neck squamous cell carcinoma is cancer that has spread from where it started to nearby tissue or lymph nodes but has not yet spread to distant parts of the body. There are several factors that greatly increase the risk of developing head and neck cancer, including tobacco and alcohol use and human papillomavirus.

(Press release, Merck & Co, OCT 29, 2025, View Source [SID1234657105])

IN8bio Expands INB-100 Phase 1 Clinical Trial with Addition of The Ohio State University as New Site

On October 29, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported that The Ohio State University has been added as a new clinical site in the ongoing Phase 1 trial of the Company’s INB-100, a donor-derived allogeneic gamma-delta T cell therapy for patients with leukemias undergoing haploidentical stem cell transplantation.

The addition of this leading academic institution reflects a strong interest in INB-100 and supports the ongoing efforts to accelerate enrollment and complete this Phase 1 trial.

"This trial is an excellent opportunity to explore a strategy aimed at reducing the risk of graft-versus-host disease and the risk of relapse following haploidentical stem cell transplant," said Sarah A. Wall, M.D., Investigator and Assistant Professor in the College of Medicine at The Ohio State University. "The increased use of haploidentical donors in the last decade has created more access to potentially life-saving allogeneic transplants for many patients, particularly under-represented groups who are less likely to have fully matched donors. I am incredibly excited to be opening and leading this trial at The James Comprehensive Cancer Center at Ohio State University."

"We are excited to welcome The Ohio State University as a clinical partner in the INB-100 study," said William Ho, CEO and co-founder of IN8bio. "With multiple sites actively screening, we look forward to completing the enrollment of the expansion cohort and providing follow-up data next year. INB-100 continues to demonstrate the potential of gamma-delta T cells to improve outcomes and reduce relapse in patients following stem cell transplantation. Multiple patients with complex, high-risk disease continue to demonstrate long-term leukemic remissions with the earliest treated patients now beyond four- and five-years relapse-free."

The INB-100 trial is being run by Principal Investigator Dr. Joseph P. McGuirk, the Schutte-Speas Professor of Hematology-Oncology, Division Director, Hematologic Malignancies and Cellular Therapeutics, Medical Director, Blood and Marrow Transplant at the Kansas University Cancer Center (KUCC). The trial is designed to evaluate the safety, durability, and anti-leukemic activity of IN8bio’s allogeneic gamma-delta T cell therapy in the post-transplant setting. The Company has previously presented clinical data demonstrating encouraging long-term survival outcomes relative to real-world historical data, immune reconstitution including expansion and persistence of the allogenic INB-100 gamma-delta T cell therapy up to 1-year post treatment, and absence of severe graft-versus-host disease.

For more information about the study NCT03533816, visit clinicaltrials.gov

(Press release, In8bio, OCT 29, 2025, View Source [SID1234657104])

Guardant Health Reports Third Quarter 2025 Financial Results and Increases 2025 Revenue Guidance

On October 29, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported financial results for the quarter ended September 30, 2025.

Third Quarter 2025 Financial Highlights

For the three-month period ended September 30, 2025, as compared to the same period of 2024:
•Reported total revenue of $265.2 million, an increase of 39%, driven by:
◦Oncology revenue of $184.4 million, an increase of 31%, and approximately 74,000 oncology tests, an increase of 40%
◦Screening revenue of $24.1 million, and approximately 24,000 Shield screening tests, compared to $1.0 million in the prior year period
◦Biopharma & Data revenue of $54.7 million, an increase of 18%
•Generated non-GAAP gross margin of 66%, compared to 63% in the third quarter of 2024
Recent Operating Highlights
•Expanded Shield to include multi-cancer detection (MCD) and initiated a large-scale real-world data initiative for Shield MCD
•Announced strong real-world performance data for Shield MCD utilizing the InfinityAI learning engine
•Established strategic collaborations with Quest Diagnostics and PathGroup to further accelerate nationwide access to Shield
•Improved stage I performance in Shield V2 CRC screening test
•Established a partnership with American Cancer Society to expand cancer screening access and advance health equity
•Reached a major milestone with the submission of Guardant360 Liquid PMA application to FDA
•Submitted Reveal immuno-oncology monitoring data package to MolDx for Medicare reimbursement
•Received new Guardant360 companion diagnostic approvals for breast cancer and non-small cell lung cancer
"This was an exceptional quarter for Guardant with broad-based growth across our business," said Helmy Eltoukhy, co-founder and co-CEO. "Oncology volumes grew 40% year-over-year, driven by very strong performance across all products, including the fifth consecutive quarter of accelerating Guardant360 Liquid volume growth. Notably, this quarter we crossed over $1 billion in annualized revenue. This sets us up well to deliver on the long-term plan we presented at our Investor Day last month."
"We made incredible progress in Screening in the third quarter. It has been very rewarding to see Shield take off and hear story after story of patients positively impacted by this pioneering test. To support the growing demand, we have accelerated our commercial infrastructure build out and established strategic collaborations with Quest Diagnostics and PathGroup to help rapidly broaden access to Shield throughout the country," said AmirAli Talasaz, co-founder and co-CEO. "Beyond CRC screening, I’m pleased to share that we have now expanded Shield to include multi-cancer detection nationwide through our clinical data initiative, bringing this important innovation to a broader population."

Third Quarter 2025 Financial Results
Revenue was $265.2 million for the third quarter of 2025, a 39% increase from $191.5 million for the corresponding prior year period. Oncology revenue grew 31% to $184.4 million for the third quarter of 2025, from $141.2 million for the corresponding prior year period, driven primarily by an increase in Oncology test volume (Guardant360 Liquid, Tissue, and Reveal), which grew 40% over the prior year period. Screening revenue was $24.1 million for the third quarter of 2025, primarily generated from approximately 24,000 Shield tests. Biopharma and Data revenue grew 18% to $54.7 million for the third quarter of 2025, from $46.5 million for the corresponding prior year period, driven primarily by the achievement of certain milestones of our service agreements. Licensing and other revenue was $2.0 million for the third quarter of 2025, compared to $2.7 million for the corresponding prior year period.
Gross profit, or total revenue less cost of revenue, was $171.6 million for the third quarter of 2025, an increase of $54.6 million from $117.0 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65%, as compared to 61% for the corresponding prior year period.

Non-GAAP gross profit was $174.3 million for the third quarter of 2025, an increase of $53.3 million or 44%, from $121.1 million for the corresponding prior year period. Non-GAAP gross margin was 66% for the third quarter of 2025, as compared to 63% for the corresponding prior year period.
Operating expenses were $270.6 million for the third quarter of 2025, as compared to $234.3 million for the corresponding prior year period. Non-GAAP operating expenses were $228.9 million for the third quarter of 2025, as compared to $187.3 million for the corresponding prior year period. The year-over-year increase in both operating expenses and non-GAAP operating expenses was primarily related to commercial team expansion and marketing activities to support the Shield product launch and existing product growth.
Net loss was $92.7 million for the third quarter of 2025, as compared to $107.8 million for the corresponding prior year period. Net loss per share was $0.74 for the third quarter of 2025, as compared to $0.88 for the corresponding prior year period.
Non-GAAP net loss was $48.3 million for the third quarter of 2025, as compared to $55.0 million for the corresponding prior year period. Non-GAAP net loss per share was $0.39 for the third quarter of 2025, as compared to $0.45 for the corresponding prior year period.
Adjusted EBITDA loss was $45.5 million for the third quarter of 2025, as compared to a $56.2 million loss for the corresponding prior year period.
Free cash flow for the third quarter of 2025 was $(45.8) million, as compared to $(55.3) million for the corresponding prior year period. Cash, cash equivalents, and restricted cash were $689.5 million as of September 30, 2025.
2025 Guidance
Guardant Health now expects full year 2025 revenue to be in the range of $965 to $970 million, representing growth of approximately 31% compared to full year 2024. This compares to the prior range of $915 to $925 million, representing annual growth of 24% to 25%.
Within this revenue range:
•Oncology revenue is now expected to grow approximately 25% year over year in 2025, compared to prior guidance of approximately 20% growth. Oncology volume is now expected to accelerate greater than 30% growth in 2025 compared to 20% growth in 2024.
•Screening revenue is now expected to be in the range of $71 to $73 million, driven by Shield volume of 80,000 to 82,000 tests. This compared to the prior range of $55 to $60 million and 68,000 to 73,000 tests.
•Biopharma & Data revenue growth is expected to continue to be in the mid-teens range.
Guardant Health now expects full year 2025 non-GAAP gross margin to be in the range of 64% to 65%, an improvement compared to prior expectations of 63% to 64%. Guardant Health now expects total non-GAAP operating expenses to be in the range of $865 to $875 million, an increase compared to the prior range of $840 to $850 million due to the continued investment in commercial team expansion and marketing activities to support the Shield product launch and existing product growth. Guardant Health continues to expect free cash flow burn to be in the range of $225 to $235 million, an improvement compared to $275 million for the full year 2024.
Webcast Information
Guardant Health will host a conference call to discuss the third quarter 2025 financial results after market close on Wednesday, October 29, 2025 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Guardant Health, OCT 29, 2025, View Source [SID1234657103])

GSK delivers strong Q3 performance and upgrades 2025 guidance

On October 29, 2025 GSK reported strong Q3 performance and upgrades 2025 guidance.

Specialty Medicines, Vaccines and General Medicines drive sales, profit and earnings growth
Total Q3 2025 sales £8.5 billion +7% AER; +8% CER
Specialty Medicines sales £3.4 billion (+16%); Respiratory, Immunology & Inflammation £1.0 billion (+15%); Oncology £0.5 billion (+39%); HIV sales £1.9 billion (+12%)
Vaccines sales £2.7 billion (+2%); Shingrix £0.8 billion (+13%); Meningitis vaccines £0.5 billion (+5%); and Arexvy £0.3
billion (+36%)
General Medicines sales £2.5 billion (+4%); Trelegy £0.7 billion (+25%)
Total operating profit >100% and Total EPS >100% driven by lower Significant legal expenses, lower CCL charges and
higher other operating income, partly offset by intangible asset impairments
Core operating profit +11% and Core EPS +14% reflecting Specialty Medicines and Vaccines growth, higher royalty income and disciplined increased investment in R&D portfolio progression in Oncology and Vaccines

Cash generated from operations of £2.5 billion with free cash flow of £1.2 billion
Q3 2025 Year to date
£m % AER % CER £m % AER % CER
Turnover 8,547 7 8 24,049 3 6
Total operating profit 2,593 >100 >100 6,832 >100 >100
Total operating margin % 30.3% 28.0ppts 28.5ppts 28.4% 14.1ppts 14.5ppts
Total EPS 49.9p >100 >100 125.1p >100 >100
Core operating profit 2,985 8 11 8,149 6 9
Core operating margin % 34.9% 0.4ppts 0.9ppts 33.9% 0.7ppts 1.0ppts
Core EPS 55.0p 11 14 146.3p 7 11
Cash generated from operations 2,520 1 6.254 19

Pipeline progress and investment delivering future growth opportunities:

4 major new product approvals achieved so far this year:
US & EU approvals for Blenrep for multiple myeloma, Penmenvy meningitis vaccine, Blujepa first-in-class antibiotic treatment for uUTIs and Nucala for COPD
US decision on depemokimab (for asthma with type 2 inflammation, nasal polyps) expected in December 2025
15 scale opportunities with PYS potential >£2 billion now expected to launch 2025-2031:
Pivotal trials started/to start by year-end for GSK’227 B7-H3 ADC for ES-SCLC; efimosfermin for treatment of MASH;
depemokimab for COPD; and GSK ‘981 (IDRx-42) for 2L GIST
Positive data support filings for tebipenem, potential new antibiotic for cUTIs; and Low Carbon Ventolin for asthma
Targeted business development further strengthens RI&I and Oncology pipeline:
Agreement with Empirico Inc. to acquire first – and potentially best-in-class – oligonucleotide candidate to treat respiratory diseases
Licensing agreement with Syndivia for early-stage ADC targeting prostate cancer

Continued commitment to shareholder returns

Dividend declared of 16p for Q3 2025; 64p expected for full year 2025
£1.1 billion spent in YTD 2025 as part of the £2 billion share buyback programme announced at FY 2024
2025 guidance upgraded
Now expect:
2025 turnover growth of between 6% to 7% (previously towards the top end of the range of between 3% to 5%);
Core operating profit growth of between 9% to 11% (previously towards the top end of the range of between 6% to 8%); and
Core EPS growth of between 10% to 12% (previously towards the top end of the range of between 6% to 8%)

(Press release, GlaxoSmithKline, OCT 29, 2025, View Source [SID1234657102])

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-012 Trial in Unresectable, Non-Metastatic Hepatocellular Carcinoma

On October 29, 2025 Eisai (Headquarters: Tokyo, CEO: Haruo Naito) and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) reported results from that Phase 3 LEAP-012 trial evaluating LENVIMA (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).

At a pre-specified interim analysis, LENVIMA plus KEYTRUDA in combination with TACE did not achieve statistical significance for overall survival (OS), one of the study’s primary endpoints, compared to TACE alone. The likelihood of reaching the protocol-specified threshold for statistical significance for OS at a future analysis was evaluated by Eisai and Merck & Co., Inc., Rahway, NJ, USA and considered to be low. On this basis, the study will be closed, and the companies are informing investigators of this decision.

The safety profile of the LENVIMA plus KEYTRUDA-based regimen was consistent with that observed in previously reported studies evaluating the combination and in earlier analyses of LEAP-012. Further analysis of the data is ongoing. Eisai and Merck & Co., Inc., Rahway, NJ, USA will work with investigators to share the results with the scientific community.

As reported previously, LENVIMA plus KEYTRUDA in combination with TACE met the study’s other primary endpoint of progression-free survival (PFS) and demonstrated a statistically significant and clinically meaningful improvement compared to TACE alone. Data from this first interim analysis, which served as the final analysis for the endpoint of PFS, were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 and published(New Window) in The Lancet. With additional follow-up at subsequent analyses, PFS remained consistent.

　"Although the progression-free survival results from this study are encouraging, unfortunately, the addition of KEYTRUDA plus LENVIMA to TACE did not show the overall survival benefit we hoped," said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, MSD Research Laboratories. "We are grateful to the patients and investigators for their important contributions to this study, and our commitment is unwavering as we pursue new therapeutic options for people living with hepatocellular carcinoma, an aggressive and challenging-to-treat cancer."

　"The overall survival findings from LEAP-012, along with the previously reported improvement in progression-free survival, provide important insights for treating unresectable, non-metastatic hepatocellular carcinoma," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai. "For years, TACE has been a standard of care for these patients, yet many experience disease progression within twelve months. With LEAP-012, we sought to make a meaningful difference for this patient population. LENVIMA continues to play an important role as a monotherapy treatment option for patients with unresectable HCC, and as a company with a deep heritage in liver cancer research, Eisai remains committed to advancing the science."

　In July 2025, LENVIMA plus KEYTRUDA in combination with TACE was approved in China to treat unresectable non-metastatic HCC. The LENVIMA plus KEYTRUDA combination is approved in the U.S., the European Union (EU), Japan and other countries for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. Results from the LEAP-012 trial do not affect the current approved indications for the LENVIMA plus KEYTRUDA combination, including the approval of LENVIMA plus KEYTRUDA in combination with TACE in China to treat unresectable non-metastatic HCC.

　LENVIMA monotherapy is approved for the treatment of patients with unresectable HCC in more than 80 countries and regions, including in the U.S., the EU, China and Japan.

　KEYTRUDA is approved as a monotherapy for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen in the U.S. and as a monotherapy for the treatment of patients with HCC who have been previously treated with sorafenib or oxaliplatin-containing chemotherapy in China.

About LEAP-012

　LEAP-012 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT04246177(New Window)) evaluating LENVIMA plus KEYTRUDA in combination with TACE versus dual placebo plus TACE for the treatment of patients with unresectable, non-metastatic HCC. The primary endpoints are PFS as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and OS. Secondary endpoints include objective response rate, duration of response, disease control rate and time to progression as assessed by BICR per above-mentioned RECIST v1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST), PFS as assessed by BICR per mRECIST and safety. The study randomized 480 patients 1:1 to receive:

LENVIMA (12 mg [for participants with screening body weight ≥60 kg] or 8 mg [for participants with screening body weight <60 kg] orally once a day) plus KEYTRUDA (400 mg intravenously [IV] every six weeks [Q6W]) in combination with TACE (conducted as a background procedure of chemotherapeutic and embolic agents injected via hepatic artery 2-4 weeks after start of study intervention, and after the first tumor assessment scan and ≥1 month after the first TACE); or
IV placebo administered Q6W plus oral placebo administered once a day in combination with TACE.
　All study drugs were continued until protocol-specified discontinuation criteria. KEYTRUDA was administered for up to two years (approximately 18 doses). After completing two years of combination therapy, LENVIMA may have been administered as a single agent until protocol-specified discontinuation criteria were met.

About hepatocellular carcinoma

　Liver cancer is one of the leading causes of cancer-related deaths worldwide.1 In the U.S., the incidence rates of liver cancer have more than tripled since 1980, and death rates have doubled during that time.2 Incidence rates are expected to continue to rise in various regions across the world until 2040, including in countries with advanced healthcare systems.3 It is estimated there were more than 866,000 new cases of liver cancer and more than 758,000 deaths from the disease globally in 2022.1 In Japan, it is estimated there were over 41,000 new cases of liver cancer and almost 26,000 deaths from the disease in 2022.4 In the U.S., it is estimated there will be approximately 42,000 patients diagnosed with liver cancer and almost 30,000 patient deaths from the disease in 2025.5 The five-year relative survival rate for liver cancer in the U.S. is 22%, based on Surveillance, Epidemiology, and End Results (SEER) data from 2015-2021.6 Hepatocellular carcinoma is the most common type of liver cancer, accounting for an estimated 85%-90% of primary liver cancer cases.7

About LENVIMA (lenvatinib) Capsules

　LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. LENVIMA has been approved for the indications below.

Thyroid cancer

・ Indication as monotherapy

　(Approved mainly in Japan, the United States, Europe, China and Asia)

　Japan: Unresectable thyroid cancer

　The United States: The treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer (DTC)

　Europe: The treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI)

Hepatocellular carcinoma

・ Indication as monotherapy

　(Approved mainly in Japan, the United States, Europe, China and Asia)

　Japan: Unresectable hepatocellular carcinoma

　The United States: The first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)

　Europe: The treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy

・ Indication in combination with KEYTRUDA (generic name: pembrolizumab) and transarterial chemoembolization (Approved in China)

Thymic carcinoma

・ Indication as monotherapy (Approved in Japan)

　Japan: Unresectable thymic carcinoma

Renal cell carcinoma (In Europe other than the United Kingdom, the agent was launched under the brand name Kisplyx)

・ Indication in combination with everolimus

　(Approved mainly in the United States, Europe and Asia)

　The United States: The treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy

　Europe: The treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy

・ Indication in combination with KEYTRUDA

　(Approved mainly in Japan, the United States, Europe and Asia)

　Japan: Radically unresectable or metastatic renal cell carcinoma

(Press release, Eisai, OCT 29, 2025, View Source [SID1234657101])

　The United States: The first-line treatment of adult patients with advanced renal cell carcinoma

　Europe: The first-line treatment of adult patients with advanced renal cell carcinoma

Endometrial carcinoma

・ Indication in combination with KEYTRUDA

　(Approved mainly in Japan, the United States, Europe and Asia)

　Japan: Unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy

　The United States: The treatment of patients with advanced endometrial carcinoma that is pMMR or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation

　Europe: The treatment of adult patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery

About KEYTRUDA (pembrolizumab) injection for intravenous use, 100mg

　KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

　Merck & Co., Inc., Rahway, NJ, USA has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.