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Last update 19 Nov 2025

Pembrolizumab

Last update 19 Nov 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Lambrolizumab, Pembrolizumab (Genetical Recombination), Pembrolizumab (genetical recombination) (JAN)

+ [11]

Target

PD-1

Action

inhibitors

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [13]

Active Indication

Locally Advanced Head and Neck Squamous Cell CarcinomaUnresectable Hepatocellular CarcinomaUnresectable Pleural Malignant Mesothelioma+ [345]

Inactive Indication

Acute myeloid leukemia with mutated NPM1Adenocarcinoma, metastaticAdvanced Colorectal Adenocarcinoma+ [90]

Originator Organization

Merck & Co., Inc.

Active Organization

MSD KK (Tokyo)Merck Sharp & Dohme BV

MSD R&D (China) Co. Ltd.

+ [12]

Inactive Organization

Viralytics Pty Ltd.

License Organization

Nektar Therapeutics

NeoImmuneTech, Inc.

Canada Pension Plan Investment Board

+ [80]

Drug Highest PhaseApproved

First Approval Date

United States (04 Sep 2014),

Melanoma

RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), PRIME (European Union), Priority Review (China), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (China), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 93660H

Source: *****

Sequence Code 93670L

Source: *****

2,536

Clinical Trials associated with Pembrolizumab

NCT06524544

/ RecruitingPhase 3IIT

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan to standard of care in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan to kill them. The usual treatment approach is treatment with chemotherapy such as cisplatin, carboplatin, gemcitabine, docetaxel or paclitaxel. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Giving pembrolizumab and sacituzumab govitecan may be more effective than usual care of carboplatin or cisplatin with gemcitabine, docetaxel or paclitaxel in treating patients with locally advanced or metastatic urothelial cancer.

Start Date20 Jul 2026

Sponsor / Collaborator

National Cancer Institute

NCT07061964

/ RecruitingPhase 2IIT

Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.

Start Date01 Jun 2026

Sponsor / Collaborator

National Cancer Institute

NCT07037004

/ Not yet recruitingPhase 2IIT

Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)

This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition of the healthy bacteria in the body (the microbiome), may improve a patient's response to treatment with immunotherapy. CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with immunotherapy for other types of cancer. Adding CBM588 to treatment with pembrolizumab after surgery may cause changes in the microbiome that improve patient response to treatment and reduce disease recurrence, compared to pembrolizumab alone.

Start Date04 May 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Pembrolizumab

100 Translational Medicine associated with Pembrolizumab

100 Patents (Medical) associated with Pembrolizumab

10,444

Literatures (Medical) associated with Pembrolizumab

01 Feb 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Targeting colorectal cancer liver metastasis through repurposing metabolic and immune inhibitors: A theoretical study

Article

Author: Lahiri, Aditya ; Datta, Aniruddha ; Mondal, Madhurima

Liver metastasis from colorectal cancer is a major cause of death in patients with advanced colorectal cancer (CRC) and remains a difficult challenge in oncology. In spite of commendable developments in medical inventions, the complexity and poor prognosis of metastatic stage, alliterative strategies are required to address Colorectal cancer liver metastasis (CRLM). This paper presents a computational study on drug repurposing for CRLM using a Boolean Network model. We comprehensively analyze CRLM signaling pathways such as WNT, PI3K/AKT/mTOR, MAPK, Hedgehog, TGF-β, NF-kB, NOTCH and HGF and target them with metabolic and immune inhibitors. This study utilizes a computational analysis to evaluate single and multi-agent treatments across scenarios involving single and multiple genetic mutations. Our findings highlights the efficacy of metabolic inhibitors such as Simvastatin, Metformin, and predict compatible partner drugs to enhance their efficacy. Additionally, we predict possible improvements for CRLM treatment using an immunotherapy drug like Pembrolizumab. Overall, this paper suggests potential combinations requiring experimental validation for drug repurposing to improve CRLM treatment outcomes.

01 Jan 2026·TALANTA

Biosimilarity and advanced structural characterization of monoclonal antibodies charge variants using capillary zone electrophoresis and mass spectrometry

Article

Author: Joomun, Rania ; Gahoual, Rabah ; Alez-Martin, Lola ; François, Yannis-Nicolas ; Mignet, Nathalie ; Houzé, Pascal

Monoclonal antibodies (mAbs) structural complexity arises from their macromolecular nature and their propensity to undergo post-translational modifications (PTM), potentially leading to the formation of charge variants. Capillary zone electrophoresis (CZE) showed to be particularly relevant for their analysis, however the selectivity provided by CZE separation is not completely elucidated. In this work, CZE-UV analysis was used to characterize charge variants for biosimilars products corresponding to infliximab. Results demonstrated the possibility to identify faint variations between the different products showing its applicability to contribute to mAbs biosimilarity assessment. Enzymatic treatment allowed to attribute the origin of infliximab charge variants. CZE-UV analysis of pembrolizumab showed that none of the five charge variants separated were originating from C-terminal lysine residues and/or N-glycans. To enable further identification, an analytical strategy was developed to achieve CZE-UV fraction collection and enrichment of mAb charge variants followed by systematic offline characterization in CE coupled to tandem mass spectrometry (MS/MS). CE-MS/MS experiments allowed the identification of different types of PTMs such as N-terminal pyroglutamic acid formation and asparagine deamidation for charge variant fractions correlated with decreased mobility. In addition, for the first time succinimide intermediate formation could be successfully characterized using CE-MS/MS data, which could be correlated to increased mobility. Thus, the CZE-UV separation resulted from the synergistic effect of several simultaneous PTMs affecting the apparent mobilities of the charge variants. As a consequence, experiments illustrated the relevance and potential of intact mAbs analysis using CZE-UV to provide an overview of the structural diversity of therapeutic mAbs.

01 Jan 2026·JOURNAL OF PHARMACEUTICAL SCIENCES

Subcutaneously administered anti-PD-(L)1 antibodies are predominantly absorbed via the lymphatic system, resulting in high drug exposure to draining lymph nodes

Article

Author: Fei, Xiaoxuan ; Sun, Lie ; Yan, Simin ; Li, Li ; Zou, Jianjun ; Ge, Weihong ; Hu, Luojuan ; Han, Sifei ; Zhang, Huimin ; Pei, Junyi

Compared to classic intravenous (IV) administration, subcutaneous (SC) delivery of monoclonal antibodies (mAbs) offers new opportunities to improve patient compliance and healthcare efficiency. However, insufficient understanding of drug absorption process following SC administration, particularly the role of lymphatic transport, may hinder the development of SC formulations for mAbs. The current study aimed to examine the absorption route of widely used anti-PD-(L)1 mAbs following SC injection, and four marketed products (Pembrolizumab, Tislelizumab, Envafolimab, Sugemalimab) were selected as the model drugs. In the thoracic lymph duct-cannulated rat model, all mAbs were found to be primarily absorbed via the lymphatics following SC injection, with 63.1-72.0 % of the administered dose recovered in the thoracic lymph, contributing to >80 % of SC bioavailability. This absorption pattern also resulted in elevated exposure of mAbs in draining lymph nodes (an order of magnitude higher drug concentrations compared to the systemic drug exposure). In addition, markedly different lymphatic absorption profiles were observed following SC administration at different sites, reflecting specific draining routes associated with certain anatomical regions in the rat. Our data suggested that the food pad is likely the optimal SC injection site for quantitative studies of lymphatic transport, whereas injection to the lower hind leg (a common SC injection site in previous studies) appeared to underestimate the absolute extent of lymphatic drug transport in the thoracic lymph duct-cannulated rat model, as lymphatic drainage from this region partially bypasses the cannulation site, leading to incomplete collection of draining lymph.

6,004

News (Medical) associated with Pembrolizumab

18 Nov 2025

·www.prnewswire.com

Kazia Therapeutics Achieves Initial iCR (Immune-Complete Response) in Metastatic TNBC and Delivers Q4 Business Update with Breakthroughs Across Breast Cancer, Immuno-Oncology, and GBM Regulatory Strategy

SYDNEY, Nov. 18, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (Nasdaq: KZIA), an oncology-focused drug development company, today announced that a patient with stage IV triple-negative breast cancer (TNBC) treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab (Keytruda®) and standard chemotherapy has achieved an initial immune-complete response (iCR) per iRECIST criteria. This outcome suggests a profound radiologic response in a highly aggressive metastatic cancer subtype. This development builds upon Kazia's October 2, 2025 announcement reporting an 86% reduction in tumor burden after only three weeks of treatment in the same patient. A PET/CT scan performed after approximately three months of therapy demonstrated complete metabolic resolution of all previously identified lesions, consistent with an initial iCR. The patient remains on therapy and under active clinical monitoring. A follow-up scan will be conducted in accordance with immune-based response assessment guidelines to confirm the initial scan. Complete responses in stage IV metastatic TNBC are exceedingly uncommon across many therapeutic classes, including immunotherapy, chemotherapy, and antibody–drug conjugates. For example, pembrolizumab monotherapy has demonstrated complete response rates of approximately 0.6–4% in metastatic TNBC across KEYNOTE studies, and even the most active approved agents—such as sacituzumab govitecan—have reported complete response rates of only ~2–4% in large Phase 2 and Phase 3 trials. In this setting, any radiologic finding consistent with an immune-complete response (iCR), even prior to confirmatory imaging, represents a highly unusual event which stands out relative to historical benchmarks for metastatic TNBC. These data may suggest enhanced biological activity of the combination regimen and warrant continued follow-up under iRECIST guidelines. "Observing an initial complete response in a patient with metastatic triple-negative breast cancer is an extremely encouraging clinical finding," said Dr. John Friend, Chief Executive Officer of Kazia Therapeutics. "Although this is a single expanded-access case and requires confirmatory imaging, the depth of response aligns closely with our mechanistic hypothesis that paxalisib may meaningfully enhance anti-tumor immunity when combined with checkpoint blockade. This outcome further energizes our Phase 1b program in advanced breast cancer and complements significant progress across our broader pipeline." Q4 BUSINESS UPDATE 1. Kazia Announces upcoming presentations related to paxalisib and NDL2 programs Kazia is pleased to announce the acceptance of two scientific presentations at the 2025 Brisbane Cancer Conference, scheduled to take place on 27–28 November 2025 in Brisbane, Australia. The Brisbane Cancer Conference is a premier oncology meeting that brings together leading international researchers, clinicians and industry experts working in the fields of translational oncology, molecular medicine and cellular therapeutics. The following presentations will take on November 27, 2025: "From bench to bedside: targeting epigenetic pathways to overcome metastasis and immunotherapy resistance in TNBC" – Sudha Rao, PhD, QIMR Berghofer (Australia) Epigenetic checkpoint blockade: A new booster to enhance immunogenicity" Sherry Tu, PhD, QIMR Berghofer (Australia) Kazia is proud to announce acceptance of two scientific presentations at the 2025 San Antonio Breast Cancer Symposium (SABCS) to be held December 10–14, 2025. SABCS is the largest and most influential breast cancer meeting globally, drawing more than 10,000 international experts in clinical oncology, translational science, immunotherapy, and molecular diagnostics. December 10, 2025 — PS2-10-02 "Liquid Biopsy Tracking of PI3K-mTOR Residual Disease Signatures in Metastatic Breast Cancer", Presenter: Prof. Sudha Rao, QIMR Berghofer (Australia) December 12, 2025 — PS5-08-04 "A Phase 1b, Multi-Centre, Open-Label, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Activity of Combining Paxalisib with Olaparib or Pembrolizumab/Chemotherapy in Patients with Advanced Breast Cancer", Presenter: Dr. Michelle Nottage, The Royal Brisbane and Women's Hospital (Australia) "SABCS is the pinnacle global meeting for breast cancer research. Being selected for two presentations is both an honor and a strong validation of our scientific direction," stated Dr. Friend. 2. NDL2 PD-L1 Degrader Program: Advancing Toward IND-Enabling Studies anticipated in Early 2026 As announced in September 2025, Kazia entered into a collaboration and licensing agreement with QIMR Berghofer covering the first in class NDL2 PD-L1 degrader program. PD-L1 degraders represent the next frontier in immuno-oncology, using a dual-mechanism approach is designed to specifically recognize and degrade the resistant, post-translationally modified forms of the PD-L1 protein. This strategy may address resistance mechanisms that limit current checkpoint inhibitors. Kazia expects to initiate IND-enabling preclinical studies in early 2026. 3. GBM Program: Advancing Toward a FDA Type C Meeting Request Following Strong Overall Survival Signals As detailed in the October 24, 2025 press release, Kazia intends to request a follow-up Type C meeting with the FDA to discuss the overall survival paxalisib findings from our completed clinical studies, alignment with the Project FrontRunner framework, potential requirements for a confirmatory study, and elements needed for a possible NDA submission pathway for paxalisib in newly diagnosed glioblastoma. "We believe paxalisib's OS data strongly justify continued engagement with the FDA and may support a more efficient regulatory strategy under Project FrontRunner," stated Dr. Friend. 4. As previously disclosed, Kazia received a notice (the "Notice") from the Listing Qualifications department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") on May 12, 2025 notifying the Company that from March 28, 2025 to May 9, 2025, the Company's Market Value of Listed Securities ("MVLS") was below the minimum of $35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the "MVLS Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq provided the Company with 180 calendar days, or until November 10, 2025 to regain compliance with the MVLS Requirement. On November 12, 2025, Kazia received a staff determination letter ("Staff Letter") from the Staff of Nasdaq indicating that the Company had not regained compliance with the MVLS Requirement by November 10, 2025. Pursuant to the Nasdaq Listing Rules and the Staff Letter, unless the Company timely requests a hearing before a Hearings Panel (the "Panel"), the Company's American Depositary Shares would be subject to suspension/delisting . The Staff Letter has no immediate effect on listing or trading, and the Company intends to timely request a hearing before the Panel, which will automatically stay any suspension or delisting action pending the outcome of the hearing. The Company believes there are remedies available to potentially stop the proceedings and is evaluating corporate and market-based options, including alternative Nasdaq equity requirements to regain compliance. For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC, [email protected], +1-201-786-8795. About Kazia Therapeutics Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024 and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in advanced breast cancer, brain metastases, diffuse midline gliomas, and primary central nervous system lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumor types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024. For more information, please visit or follow us on X @KaziaTx. Forward-Looking Statements This announcement contains forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "plan," "intend," "estimate," "future," "forward," "potential," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward looking statements, including, but not limited to, statements regarding: additional confirmatory imaging and analysis to be performed on the TNBC patient treated with paxalisib and pembrolizumab (Keytruda®), the potential benefits of NDL2 and the plans and goals of developing NDL2 formulation, the anticipated development pathways and combinations of NDL2, the timing for results and data related to Kazia's clinical and preclinical trials, the upcoming scientific presentations, Kazia's intention to request and hold a Type C meeting with the FDA to discuss OS findings in GBM patients treated with paxalisib and to seek agency feedback on a potential regulatory pathway, the plan to propose initiation of the post-approval, randomized Phase 3 confirmatory study prior to submission of the NDA, the intention to present survival analyses, supporting clinical safety and planned confirmatory trial design for FDA discussion, Kazia's intention to reference Project FrontRunner principles in its Type C briefing package, the objective to work collaboratively with the FDA under the guiding principles of Project FrontRunner, the plan to pursue a conditional approval in the front-line treatment setting of GBM, the plan to initiate the post-approval, randomized Phase 3 study prior to filing the NDA, the goal of ensuring that Kazia's development plan and regulatory strategy fully reflects and aligns with the FDA's framework and emphasis, the timing for results and data related to Kazia's clinical and preclinical trials, Kazia's strategy and plans with respect to its paxalisib program, the potential benefits of paxalisib, timing for any regulatory submissions or discussions with regulatory agencies and the potential market opportunity for paxalisib, regaining compliance with the MVLS Requirement and any other Nasdaq listing requirements, the timing and likelihood of requesting and successfully completing a hearing before the Panel and maintaining Kazia's listing on Nasdaq. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties associated with clinical and preclinical trials and product development, including the risk that interim or early data may not be consistent with final data, risks related to regulatory approvals, risks related to the impact of global economic conditions, and risks related to Kazia's ability to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. These and other risks and uncertainties are described more fully in Kazia's most recent Annual Report on form 20-F filed with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. SOURCE Kazia Therapeutics Limited 21% more press release views with Request a Demo

Clinical ResultPhase 3License out/inFast TrackImmunotherapy

18 Nov 2025

·www.biospace.com

Genmab Prunes Another ADC From $1.8B ProfoundBio Acquisition

iStock, Ekaterina Chergik Only one clinical-stage asset from the ProfoundBio acquisition remains in development: The antibody-drug conjugate Rina-S, in late-stage studies for ovarian and endometrial cancer. Genmab has scrapped another antibody-drug conjugate picked up in its $1.8 billion acquisition of ProfoundBio last year, continuing the pruning of that company’s molecules. The asset, dubbed GEN1160, was in a Phase I/II study assessing its safety and efficacy for blood cancers and solid tumors. The trial was cut “due to slow enrollment,” according to an update to a federal clinical trials database. Confirming the move to Fierce Biotech , a Genmab spokesperson added that GEN1160 is being shelved “in line with our portfolio prioritization strategy.” “This approach ensures we focus our resources on developing innovative antibody medicines with the greatest potential to make a meaningful impact for patients,” the spokesperson said. Monday’s news comes after Genmab in September discontinued the development of GEN1107, another antibody-drug conjugate (ADC) that was in Phase I/II development, but this time for advanced solid tumors, including ovarian, endometrial and triple-negative breast cancer. According to its own Clinical Trials.gov page , GEN1107 was abandoned because its “overall benefit-risk pro longer supports continuation.” GEN1160 and GEN1107 are two of the three clinical-stage cancer assets obtained by Genmab in its $1.8 billion acquisition of ProfoundBio in April 2024. The remaining clinical molecule from that deal, rinatabart sesutecan (Rina-S), the centerpiece of the acquisition, remains in development. Rina-S is in late-stage development for platinum-resistant ovarian cancer and endometrial cancer. The drug had a readout last month in endometrial cancer at the 2025 meeting of the European Society for Medical Oncology. In the Phase I/II RAINFOL-01 study, Rina-S, which was dosed every 3 weeks, elicited a 50% confirmed objective response rate over a median follow-up of 1 year. RAINFOL-01 enrolled heavily pretreated patients with endometrial cancer whose disease had progressed even after platinum-based chemotherapy and immune checkpoint inhibition. The study also documented two complete responses. Meanwhile, in March, Genmab released Phase I/II data for Rina-S in ovarian cancer, touting a confirmed objective response rate of 55.6% in heavily pretreated patients, with median duration of response not yet reached. Elsewhere in its oncology push, Genmab in September acquired rising cancer star Merus for $8 billion. The buyout, which represented a 41% premium to Merus’ closing price the day before the deal was announced, will give Genmab the bispecific antibody petosemtamab that binds both EGFR and LGR5 markers. In May, petosemtamab plus Keytruda treatment resulted in a 79% overall survival rate at 12 months in a Phase II study of head-and-neck squamous cell carcinoma. The overall response rate was 63%.

Clinical ResultAcquisitionPhase 2ADCImmunotherapy

18 Nov 2025

·www.biopharmadive.com

Merck’s blockbuster-to-be cardiovascular drug scores in another heart study

With new, positive data in hand, Merck & Co. plans to move its cardiovascular drug Winrevair into late-stage testing as a treatment for a condition often caused, at least in part, by high blood pressure.This condition known as heart failure with preserved ejection fraction, or HFpEF is common, affecting more than half of the roughly 6.7 million people in the U.S. believed to be living with heart failure. In these people, the hearts main pumping chamber stiffens over time due to a variety of possible factors, including age, obesity and hypertension. While the chamber still pumps a normal amount of blood, patients with HFpEF can experience fatigue, shortness of breath, as well as life-threatening health complications.The Food and Drug Administration has already approved several medicines for HFpEF, among them AstraZenecas Farxiga, Novartis Entresto, and Eli Lilly and Boehringer Ingelheims Jardiance. Merck has been trying to expand that list with Winrevair, a first-of-its-kind therapy that works by regulating signals from activin proteins that spur cell growth and division. In heart failure, the over-production of certain cells, molecules and proteins can harden the organ and impair its function.On Tuesday, Merck announced Winrevair had hit the main goal of a mid-stage clinical trial that enrolled 164 adults with high blood pressure in their pulmonary arteries caused by HFpEF. The study pitted two different doses of Winrevair against a placebo and, according to Merck, showed that about six months into treatment, the drug provided a significant and clinically meaningful improvement to blood flow through the lungs to the heart.In a statement, Mahesh Patel, vice president of global clinical development at Merck Research Laboratories, said these kinds of blood flow improvements could translate to better outcomes for this patient population.Merck didnt release any detailed data, but said it intends to present results at a future scientific meeting. In the meantime, its forging ahead into Phase 3 development.For Merck, which stands to lose patent protection on the worlds top-selling drug, Keytruda, in the not-too-distant future, the success of products like Winrevair is crucial. In 2024, Keytruda accounted for a little over half of the companys $57.4 billion in pharmaceutical sales.Merck picked up Winrevair through its $11.5 billion acquisition of Acceleron Pharma back in 2021. The drug is one of 20 growth drivers that, by Mercks estimates, could eventually make up for the expected declines to the Keytruda franchise. The company argues that almost all of these drivers have the potential to generate at least $1 billion in annual revenue and, collectively, their commercial opportunity exceeds $50 billion.Winrevair first received FDA approval in the spring of 2024, for a separate blood pressure disorder called pulmonary arterial hypertension. Sales of the drug totaled $976 million over the first nine months of this year.Carter Gould, an analyst at the investment firm Cantor Fitzgerald, wrote in a note to clients that this latest trial win should help Mercks stock price, especially since investors were ascribing value to Winrevair beyond PAH.Gould added that, among analysts, the average forecast has annual Winrevair sales peaking at $8 billion to $8.5 billion, with around $1 billion to $2 billion coming from outside of PAH, namely HFpEF.Merck shares were up more than 3%, to trade above $96 apiece, by late Tuesday morning. '

Drug ApprovalAcquisitionAHA

100 Deals associated with Pembrolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10574	Pembrolizumab	L01XC18	DB09037

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Locally Advanced Head and Neck Squamous Cell Carcinoma	Iceland	Merck Sharp & Dohme BV	30 Oct 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma	Liechtenstein	Merck Sharp & Dohme BV	30 Oct 2025
Locally Advanced Head and Neck Squamous Cell Carcinoma	Norway	Merck Sharp & Dohme BV	30 Oct 2025
Unresectable Hepatocellular Carcinoma	China	Merck Sharp & Dohme LLC	10 Jun 2025
Unresectable Pleural Malignant Mesothelioma	Iceland	Merck Sharp & Dohme BV	16 Apr 2025
Unresectable Pleural Malignant Mesothelioma	Norway	Merck Sharp & Dohme BV	16 Apr 2025
Unresectable Urothelial Carcinoma	European Union	Merck Sharp & Dohme BV	25 Jul 2024
Unresectable Urothelial Carcinoma	Iceland	Merck Sharp & Dohme BV	25 Jul 2024
Unresectable Urothelial Carcinoma	Liechtenstein	Merck Sharp & Dohme BV	25 Jul 2024
Unresectable Urothelial Carcinoma	Norway	Merck Sharp & Dohme BV	25 Jul 2024
Advanced Endometrial Carcinoma	United States	Merck Sharp & Dohme LLC	17 Jun 2024
Microsatellite instability-high Endometrial Carcinoma	United States	Merck Sharp & Dohme LLC	17 Jun 2024
Mismatch repair-deficient Endometrial Carcinoma	United States	Merck Sharp & Dohme LLC	17 Jun 2024
Advanced gastric carcinoma	Japan	MSD KK (Tokyo)	17 May 2024
recurrent gastric cancer	Japan	MSD KK (Tokyo)	17 May 2024
Unresectable Biliary Tract Carcinoma	Canada	Merck Sharp & Dohme Corp.	09 May 2024
Advanced biliary tract cancer	China	Merck Sharp & Dohme LLC	30 Jan 2024
Locally Advanced Cholangiocarcinoma	China	Merck Sharp & Dohme LLC	30 Jan 2024
stomach adenocarcinoma	Norway	Merck Sharp & Dohme BV	20 Dec 2023
HER2 negative Gastric Cancer	United States	Merck Sharp & Dohme LLC	16 Nov 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Muscle Invasive Bladder Carcinoma	NDA/BLA	United States	Merck & Co., Inc.	23 Oct 2025
Recurrent Platinum-Resistant Ovarian Carcinoma	NDA/BLA	United States	Merck & Co., Inc.	20 Oct 2025
Small intestine carcinoma	NDA/BLA	European Union	Merck Sharp & Dohme Corp.	25 Mar 2022
Ovarian Epithelial Carcinoma	Phase 3	United States	Merck Sharp & Dohme Corp.	13 Dec 2021
Ovarian Epithelial Carcinoma	Phase 3	Japan	Merck Sharp & Dohme Corp.	13 Dec 2021
Ovarian Epithelial Carcinoma	Phase 3	Belgium	Merck Sharp & Dohme Corp.	13 Dec 2021
Ovarian Epithelial Carcinoma	Phase 3	Canada	Merck Sharp & Dohme Corp.	13 Dec 2021
Ovarian Epithelial Carcinoma	Phase 3	Colombia	Merck Sharp & Dohme Corp.	13 Dec 2021
Ovarian Epithelial Carcinoma	Phase 3	Denmark	Merck Sharp & Dohme Corp.	13 Dec 2021
Ovarian Epithelial Carcinoma	Phase 3	Germany	Merck Sharp & Dohme Corp.	13 Dec 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05052723 (CTgov)	Phase 2	Metastatic Pancreatic Cancer	21	Cabozantinib+Pembrolizumab	dhpmabbhto = mrhbsfpbzj quzhinaabt (pjfemlrpbc, woojlnuiho - ekikznihbj) View more	-	19 Nov 2025
NCT04454489 (CTgov)	Phase 2	Squamous cell carcinoma of head and neck metastatic \| Advanced Head and Neck Squamous Cell Carcinoma \| Recurrent Squamous Cell Carcinoma of the Head and Neck ... View more	21	Quad-shot palliative radiotherapy+Pembrolizumab (immunotherapy)	imgwcdvxpu = gnqxxdeyoc feoktvnell (lxhapestxj, hitnlqixwf - iqazdtoxww) View more	-	19 Nov 2025
NCT03797326 (E7080-G000-224 \| MK-7902-005 \| LEAP-005 \| 7902-005, CTgov)	Phase 2	Glioblastoma \| Advanced Malignant Solid Neoplasm \| Gallbladder Carcinoma ... View more	611	Pembro+Lenva (Cohort A: Triple Negative Breast Cancer (Lenva + Pembro))	jjorzgvkvq = wxewoycdhb fqfcavbwtl (ylzjibmnde, aerrzvpqmb - dflgenboqj) View more	-	17 Nov 2025
	Phase 2		611	Pembro+Lenva (Cohort B: Ovarian Cancer (Lenva + Pembro))	jjorzgvkvq = lcixbdbvjf fqfcavbwtl (ylzjibmnde, tzepvsubso - uazmafcped) View more	-	17 Nov 2025
NCT03160079 (CTgov)	Phase 1/2	Adult Acute Lymphocytic Leukemia	16	pembrolizumab+blinatumomab	fknrpgrexn = lsedjnehzs vcpqnjbrnl (yxoumpybjc, lpmeracjab - luhvxupxui) View more	-	07 Nov 2025
SITC2025	Not Applicable	Adenocarcinoma of large intestine Adjuvant MSI-H \| dMMR \| TMB	1	Pembrolizumab (Hypermutated colorectal adenocarcinoma)	mqvimqgmuf(hqgdfcnthe) = without disease progression zgsdmgtupq (vdwuzdrdqd ) View more	Positive	05 Nov 2025
NCT05784688 (SITC2025)	Phase 2	Squamous Cell Carcinoma of Head and Neck PD-L1 expression (CPS ≥1)	12	TU2218 195 mg/day + Pembrolizumab 200 mg	opijllnoxe(yxlyfdkzbp) = ohlmuyrtgo grcpsvyjuz (pngdsstucx ) View more	Positive	05 Nov 2025
SITC2025	Not Applicable	Sinonasal Squamous Cell Carcinoma PD-L1 \| TMB \| MSI-high ... View more	13	Immune checkpoint inhibitors	pwsklntucr(hmrpntygeu) = vwuyxjiqge mpkofuhsdu (dsjpcfjhsz ) View more	Positive	05 Nov 2025
SITC2025	Not Applicable	Gastrointestinal Neoplasms Microsatellite instability-high (MSI-H) \| high tumor mutational burden (TMB) \| POLE exonuclease-domain mutations	1,025	pembrolizumab (Microsatellite instability-high)	qritanvkrx(zbdrtpzntx) = uvklhzfgik dlaavtsvgw (jmfiitmakn )	Positive	05 Nov 2025
SITC2025	Not Applicable		1,025	Chemotherapy (Microsatellite instability-high)	qritanvkrx(zbdrtpzntx) = uubacxhrbo dlaavtsvgw (jmfiitmakn )	Positive	05 Nov 2025
SITC2025	Not Applicable	Triple Negative Breast Cancer Neoadjuvant	6	Pembrolizumab 200mg every 3 weeks for 8 cycles + Weekly Paclitaxel + Carboplatin for 12 weeks, followed by Anthracycline + Cyclophosphamide every 3 weeks for 4 cycles	rdymxotmlw(hzyapadcuw) = orirbiekzd admrjpwyxw (nazcfilxnm )	Positive	05 Nov 2025
SITC2025	Not Applicable	Melanoma Neoadjuvant	52	Nivolumab + Ipilimumab	grtqtvssxv(uoemhrikwk) = yqcjiaopld fzvrlwybjd (vdykunbjnz ) View more	Positive	05 Nov 2025
SITC2025	Not Applicable	Melanoma Neoadjuvant	52	Pembrolizumab	grtqtvssxv(uoemhrikwk) = lvswaqniyc fzvrlwybjd (vdykunbjnz ) View more	Positive	05 Nov 2025

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