Request Demo

Last update 06 Oct 2025

Pembrolizumab

Last update 06 Oct 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

Unresectable Hepatocellular CarcinomaMalignant Pleural MesotheliomaUnresectable Urothelial Carcinoma+ [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

+ [74]

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: *****

2,511

Clinical Trials associated with Pembrolizumab

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]

NCT07199413

/ Not yet recruitingPhase 1IIT

Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy: A Phase I Pilot Safety and Feasibility Study for Solid Tumor Patients With CNS Metastases

This is a prospective, single-center, phase 1 basket trial that will evaluate the safety and feasibility of administering SV-BR-1-GM in combination with pembrolizumab to solid tumor oncology patients over nine cycles.

Start Date01 Mar 2026

Sponsor / Collaborator

Medical College of Wisconsin

100 Clinical Results associated with Pembrolizumab

100 Translational Medicine associated with Pembrolizumab

100 Patents (Medical) associated with Pembrolizumab

10,874

Literatures (Medical) associated with Pembrolizumab

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.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

The cost-effectiveness of treatment for high-risk, early-stage, triple-negative breast cancer in Egypt: an analysis of neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant single-agent pembrolizumab

Article

Author: Haiderali, Amin ; Huang, Min ; Abdelaziz, Ahmed H. ; Pöllinger, Bernadette ; Kassem, Loay ; Akyol Ersoy, Burcu ; Elsisi, Gihan Hamdy

OBJECTIVE:

The cost-effectiveness of neoadjuvant pembrolizumab + chemotherapy followed by adjuvant pembrolizumab compared to neoadjuvant chemotherapy plus placebo followed by adjuvant placebo was assessed in high-risk, early-stage, triple-negative breast cancer patients from an Egyptian societal perspective over a lifetime horizon.

METHODS:

A 4-state Markov cohort model was developed to compare the cost-effectiveness of pembrolizumab + chemotherapy/pembrolizumab vs chemotherapy alone for the treatment of high-risk, early-stage, triple-negative breast cancer. The model simulated the clinical course of high-risk, early-stage, triple-negative breast cancer across four health states: event-free survival, locoregional recurrence, distant metastasis, and death. Clinical inputs for the simulation were derived from modeling of efficacy and safety data collected in the KEYNOTE-522 trial. Direct medical costs and indirect costs were reported in 2022 Egyptian pounds (EGP) and converted to US dollars ($). Probabilistic and deterministic sensitivity analyses were conducted to assess the robustness of model results.

RESULTS:

Compared with chemotherapy alone, pembrolizumab + chemotherapy/pembrolizumab led to expected gains of 2.92 life years and 2.25 quality-adjusted life years, respectively, while increasing overall treatment costs by EGP 491,695 ($102,436). Incremental costs per year gained were EGP 218,285 ($45,476) per quality-adjusted life year and EGP 168,223 ($35,046) per life year, both of which were lower than the 2022 Egyptian cost-effectiveness threshold of EGP 398,439 ($83,008). The findings of sensitivity analyses indicated that the model was robust across a range of inputs and assumptions.

CONCLUSIONS:

In Egypt, pembrolizumab + chemotherapy/pembrolizumab is a cost-effective treatment for high-risk, early-stage, triple-negative breast cancer when considering health-related quality-of-life and years of life gained.

31 Dec 2025·OncoImmunology

Clinical impact of cancer cachexia on the outcome of patients with non-small cell lung cancer with PD-L1 tumor proportion scores of ≥50% receiving pembrolizumab monotherapy versus immune checkpoint inhibitor with chemotherapy

Article

Author: Katayama, Yuki ; Hasegawa, Isao ; Kijima, Takashi ; Iwasaku, Masahiro ; Kawachi, Hayato ; Date, Koji ; Yamada, Tadaaki ; Shimose, Takayuki ; Nakao, Akira ; Harada, Taishi ; Okada, Asuka ; Tokuda, Shinsaku ; Morimoto, Kenji ; Tamiya, Motohiro ; Nishioka, Naoya ; Shiotsu, Shinsuke ; Tanimura, Keiko ; Goto, Yasuhiro ; Takayama, Koichi ; Negi, Yoshiki ; Tamiya, Nobuyo ; Chihara, Yusuke ; Takeda, Takayuki

This retrospective, multicenter cohort study aimed to determine whether cancer cachexia serves as a biomarker for determining the most effective treatment for patients having non-small-cell lung cancer (NSCLC) with high programmed death ligand 1 (PD-L1) expression treated with immune checkpoint inhibitors (ICIs) alone or combined with chemotherapy (ICI/chemotherapy). We included 411 patients with advanced NSCLC with a PD-L1 tumor proportion score of ≥50%. The patients were treated with pembrolizumab monotherapy or ICI/chemotherapy. Cancer cachexia was defined as a weight loss of >5% of the total body weight or a body mass index of <20 kg/m² coupled with an additional weight loss of >2% within 6 months before starting treatment. Eighty-five (21%) patients met the cancer cachexia criteria. Overall survival (OS) was significantly shorter in patients with cachexia than in those without cachexia in both the pembrolizumab monotherapy group (17.2 vs. 35.8 months, p < 0.001) and the ICI/chemotherapy group (27.0 months vs. not reached, p = 0.044). However, after stratifying by cancer cachexia status, no significant difference in OS was observed between the pembrolizumab monotherapy and chemoimmunotherapy groups, regardless of cachexia. In conclusion, ICI/chemotherapy offers limited benefits for NSCLC patients with high PD-L1 expression and concurrent cancer cachexia. Considering the frailty associated with cachexia, ICI monotherapy may be preferred to ICI/chemotherapy for these patients. New interventions that can better address the negative prognostic impact of cachexia in patients treated using ICIs with or without chemotherapy remain warranted.

5,791

News (Medical) associated with Pembrolizumab

03 Oct 2025

·www.globenewswire.com

Evaxion to present new biomarker data for AI-designed personalized cancer vaccine EVX-01 at the SITC 2025 Annual Meeting

New biomarker and immune data from the ongoing phase 2 trial with EVX-01 will be presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting The data will be the latest of many additions to EVX-01’s strong data packageTwo-year clinical efficacy data from the trial will be presented at the European Society for Medical Oncology (ESMO) 2025 congress on October 17, 2025 COPENHAGEN, Denmark, October 3, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will present new data for its lead asset EVX-01 at a poster session at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting taking place in National Harbor November 5-9, 2025. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). Evaxion will present new biomarker and immune data stemming from the ongoing phase 2 trial with EVX-01. The two-year clinical efficacy data from the trial will, as earlier announced, be presented in an oral presentation at the ESMO 2025 congress on October 17, 2025. Both datasets will add to an already strong data package for EVX-01, which includes convincing one-year interim data from the phase 2 trial. The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. SITC presentation details: Abstract title: Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patientsAbstract#: 605Poster#: 605Session (category): Clinical trials in progress (subcategory: Skin cancers)Location: Lower Level Atrium - Prince George's ABCDate/Time: Friday, November 7, 2025, 5:10–6:35 p.m. ET/23.10-00.35 CET Presenter: Michail Angelos Pavlidis, Research Associate at Evaxion About EVX-01 EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset. EVX-01 is designed with our AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In clinical trials, EVX-01 has demonstrated 69% and 67% Overall Response Rates in patients with advanced melanoma. Further, significant correlations between clinical responses and AI-Immunology™ predictions have been observed, underlining the predictive power of the platform. Contact information Evaxion A/SMads KronborgVice President, Investor Relations & Communication+45 53 54 82 96 mak@evaxion.ai About Evaxion Evaxion is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

VaccinePhase 2Immunotherapy

03 Oct 2025

·www.bioinvent.com

BioInvent to Present Phase 1 Clinical Data for BI-1910, a TNFR2 Agonist for the Treatment of Solid Tumors, at SITC

As previously reported, the single agent dose escalation of BI-1910 in the Phase 1 study was completed without any notable adverse events Updated clinical data will be presented at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting to be held November 5-9, 2025, at National Harbor, MD (USA) Lund, Sweden – October 03, 2025 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, will present a poster with data from its trial of BI-1910 at the upcoming SITC Annual Meeting. The abstract title, which was released today, is “Preliminary Phase 1 results of clinical trial investigating BI-1910, a Tumor Necrosis Factor Receptor 2 (TNFR2) agonist in solid cancer tumor patients.” BI-1910 is part of BioInvent’s tumor-associated regulatory T cells (Treg)-targeting program, where currently the most advanced program, the Phase 2 program BI-1808, has been prioritized. As announced in August of this year, following a comprehensive strategic review - BioInvent decided to concentrate on advancing BI-1808 (as well as BI-1206, an FcyRIIB-blocking antibody). As part of this review, BioInvent is pausing the development of BI-1910. TNFR2 is particularly upregulated on Tregs of the tumor microenvironment and has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapy. Poster details:Title: Preliminary Phase 1 results of clinical trial investigating BI-1910, a Tumor Necrosis Factor Receptor 2 (TNFR2) agonist in solid cancer tumor patients.Abstract number: 581Date: November 7-8, 2025Authors: Hernandez T., Doger B., Yachnin J., Staahl Rorberg K., Moreno I., Carneiro A., Falcon Gonzalez A., Holmkvist P., Karlsson I., Lindahl D., Meller M., Mårtensson L., Schoenborn-Kellenberger O., Sundstedt A., Teige I., Piliuhin D., Vaapil M., Wallin J., Frendéus B., McAllister A. The abstract will be published in the Journal for ImmunoTherapy of Cancer (JITC) Abstract Supplement. A link to the supplement will be posted on the SITC website on November 4, 2025. ### BI-1910 Phase 1/2a Clinical Trial (NCT06205706)During this part of the Phase 1/2a study the safety, tolerability, and potential signs of efficacy of BI-1910 as a single agent were evaluated in patients with advanced solid tumors. As previously reported in January of this year, the single agent dose escalation of BI-1910 in the Phase 1 study has successfully been completed without any notable adverse events. Out of the 12 evaluable patients, six patients displayed stable disease. Early results indicated favorable pharmacokinetic data and robust target engagement, with patients in the target dose range showing evidence of induction of T cell proliferation. About BI-1910BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent’s first-in-class anti-TNFR2 antibody currently in a Phase 1/2a development. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent’s proprietary F.I.R.S.T™ technology platform. BI-1910 is an agonistic human IgG2 mAb targeting TNFR2. BI-1910 stimulates T cells and enhances the activation of both CD4+ and CD8+ T cells. It binds selectively to TNFR2 without inhibiting TNF-a binding. In preclinical models, BI-1910 combined with anti-PD1 showed additive anti-tumor activity, justifying clinical evaluation with pembrolizumab. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

Phase 1ImmunotherapyClinical ResultPhase 2AACR

03 Oct 2025

·www.biopharmadive.com

FDA clears generic abortion pill; CMS punts ‘combo drug’ guidance

Listen to the article 5 min This audio is auto-generated. Please let us know if you have feedback. Today, a brief rundown of news involving Medicare and the Food and Drug Administration, as well as updates from Ovid Therapeutics, Taysha Gene Therapies and Bolt Biotherapeutics that you may have missed.Subcutaneous versions of cancer drugs Merck & Co.s Keytruda and Bristol Myers Squibbs Opdivo wont be subject to Medicare price negotiations in 2028 as investors had feared, but could be in 2029, according to guidance from the Centers for Medicare and Medicaid Services. The policy in particular might have affected drugs that launched as intravenous infusions and were later converted into under-the-skin injections, subcutaneous shots through the use of technologies developed by Halozyme and others. In comments to the agency, some drug companies claimed CMS didnt have the legal authority to group subcutaneous and intravenous products together, and that doing so might discourage drug research. Due to the complexity and scope of this issue as noted above in stakeholder comments, CMS believes additional time would be necessary to develop objective policy criteria, the agency wrote. Jonathan GardnerThe FDA on Thursday approved a second generic version of the abortion pill mifepristone, sparking backlash from some conservative politicians and anti-abortion groups. An FDA letter shows the agency clearedprivately held Evita Solutions form of the drug, which is one of two pills commonly used to terminate a pregnancy within the first trimester. The approval comes after HHS Secretary Robert F. Kennedy Jr and FDA Commissioner Martin Makary vowed last month to reevaluate the safety of mifepristone, which has been consistently proven safe in studies since its initial approval more than two decades ago. Delilah AlvaradoOvid Therapeutics, a New York-based biotechnology company, on Thursday said that its most advanced experimental drug succeeded in an early-stage study of healthy volunteers. The drug, “OV329,“ is designed to inhibit enzymes that break down “GABA,“ a neurotransmitter that calms brain cells. Ovid said multiple biomarker tests found treatment with OV329 resulted in “highly significant“ enzyme inhibition, giving the company confidence to further study the medicine as a potential seizure therapy. Ovid also reported “favorable“ safety data and “no evidence“ of changes in participants' visual health. The biotech, which hit major setbacks with other drugs for epilepsies and a rare genetic disorder, saw its share price rise nearly 12% Thursday morning, to trade around $1.83. Alongside the study findings, Ovid disclosed it is conducting a “PIPE“ financing that could be worth up to $175 million. Jacob BellCidara Therapeutics received a $339 million award from the Biomedical Advanced Research and Development Authorityto support development of CD388, its preventive therapy for flu infections. Cidara posted positive mid-stage study results for the drug a potential alternative to flu vaccines in June,and its market value has more than quadrupled since. The BARDAaward will help with onshore manufacturing and run additional studies that would support a U.S. approval submission. Ben FidlerShares of Taysha Gene Therapies surged 50% on Thursday after the company aligned with the FDAon the design of a pivotal study evaluating its experimental treatment for the rare disease Rett syndrome. The single arm, open-label trial will include a six-month interim analysis that could enable a speedy approval submission if the results are positive, and a 33% response rate has been established as the “minimum threshold“ for success, Taysha said. The update is a boost for Taysha as well as its Rett syndrome gene therapy rival Neurogene, as it shows “regulatory flexibility and a very achievable bar for success,“ wrote Leerink Partners analyst Mani Foroohar. Neurogene shares climbed by double digits as well. Ben FidlerBolt Biotherapeutics is cutting its workforce in half for the second time in the last two years. The company was initially expecting data from a Phase 1 dose study of its cancer antibody drug,dubbed BDC-4182, in the first half of 2026. But its now evaluating a different dosing strategy, which is delaying the results to the third quarter and leading to a new restructuring thatll extend its cash runway into 2027. Bolt previously laid off staff in 2024 when its then-lead drug didnt meet its high bar for advancement.Bolt switched its focus to two earlier prospects, including BDC-4182. Delilah AlvaradoCirrus Therapeutics announced a $11 million seed financing round on Thursday that the company will use to bring a gene therapy for the dry form of age-related macular degeneration into preclinical testing. Cirrus treatment is designed to reverse a recently identified cause of dry AMD, the loss of an immune-regulating protein protein called IRAK-M.The seed round was led by ClavystBio, with participation from Polaris Partners and SEEDS. Gwendolyn WuCorrection: A previous version of this story misspelled the name of the company Neurogene. '

Drug ApprovalGene TherapyClinical ResultVaccine

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
Unresectable Hepatocellular Carcinoma	China	Merck Sharp & Dohme LLC	10 Jun 2025
Malignant Pleural Mesothelioma	United States	Merck & Co., Inc.	17 Sep 2024
Malignant Pleural Mesothelioma	United States	Merck Sharp & Dohme LLC	17 Sep 2024
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
Resectable Lung Non-Small Cell Carcinoma	United States	Merck Sharp & Dohme Corp.	16 Oct 2023
HER2 Positive Stomach Adenocarcinoma	European Union	Merck Sharp & Dohme BV	06 Sep 2023
HER2 Positive Stomach Adenocarcinoma	Iceland	Merck Sharp & Dohme BV	06 Sep 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Head and Neck Squamous Cell Carcinoma	NDA/BLA	United States	Merck Sharp & Dohme LLC	25 Feb 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
Ovarian Epithelial Carcinoma	Phase 3	Israel	Merck Sharp & Dohme Corp.	13 Dec 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03426891 (CTgov)	Phase 1	Glioblastoma Multiforme	21	Radiotherapy+Vorinostat+Temozolomide+Pembrolizumab (Dose Escalation Phase)	dvphrrnhrn = ztjhbybdcw aeqkosvzue (eedxxgsfby, egtsgqhmzt - mjxmqespco) View more	-	06 Oct 2025
				Radiotherapy+Vorinostat+Temozolomide+Pembrolizumab (Radiotherapy and Maintenance Phase)	rfznzmikoo(xhctfnfczx) = vnfyxrkvsn yvakhpbilb (ppjdgpxcvg, viskwguomy - hauaqlxnqv) View more
NCT05263492 (CTgov)	Phase 2	Recurrent Endometrial Cancer	4	Pembrolizumab+Lenvatinib	ysjfvzmqgr = hkaipzsbqb vlwltlccav (zvznwpyevh, kavycstdti - yawiyamonr) View more	-	02 Oct 2025
NCT02362594 (KEYNOTE-054, FDA_CDER) Manual	Phase 3	Melanoma Adjuvant	1,019	Pembrolizumab 200 mg every 3 weeks	uuvlqtsvhv(rpwgpuljui) = cjttjfepkx oamxutcubr (oxpddnssuw ) View more	Positive	19 Sep 2025
				Placebo	uuvlqtsvhv(rpwgpuljui) = vrnzrhegiv oamxutcubr (oxpddnssuw ) View more
NCT02220894 (KEYNOTE-042, FDA_CDER) Manual	Phase 3	PD-L1 positive Lung Cancer First line	1,873	Pembrolizumab 200 mg every 3 weeks (TPS ≥1%)	whxitobwuj(koqwoipfju) = ktcshwghek bgjuzxojzh (sriazxxgam, 13.9 - 19.7) View more	-	19 Sep 2025
				Chemotherapy (TPS ≥1%)	whxitobwuj(koqwoipfju) = uiwdgxjhjb bgjuzxojzh (sriazxxgam, 11.3 - 13.3) View more
NCT04224740 (HERCULES, Pubmed \| JAMA Oncol)	Phase 2	Penile Neoplasms First line	33	Pembrolizumab plus platinum-based chemotherapy	bbkyrvleot(svqvtsyfgr) = vjmxufureg mdarmtagzi (eafungftbo, 22.9 - 57.9) View more	Positive	18 Sep 2025
NCT04383743 (CTgov)	Phase 2	Non-Muscle Invasive Bladder Urothelial Carcinoma \| Muscle Invasive Bladder Carcinoma	17	Radical Cystectomy+Doxorubicin+cisplatin+Pembrolizumab+Vinblastine Sulfate+Methotrexate	pjlhkcwbyc = itxdnhlqzk xpwmwichsm (uuyjuivcpg, ykeuyowetg - mmioubytrx) View more	-	18 Sep 2025
NCT05036681 (CTgov)	Phase 2	Neoplasm Metastasis \| Metastatic endometrial cancer	9	Futibatinib+Pembrolizumab	otlldvbmmc = brfrpnyfio tciocbpiao (wlixkjgnpu, hgallaydxn - scpjheybdl) View more	-	17 Sep 2025
NCT03307759 (SABRseq, CTgov)	Phase 1	metastatic non-small cell lung cancer	13	Radiotherapy (SABR)+Pembrolizumab (SABR Plus Pembrolizumab)	plajhceakg = crtywmhjbq qgtrdsqopk (eeicfejtzc, uzyglrlajy - hsbcixjfbx) View more	-	15 Sep 2025
				Radiotherapy (SABR)+Pembrolizumab (Pembrolizumab Plus SABR)	plajhceakg = bghihbzysy qgtrdsqopk (eeicfejtzc, pxvmitxaya - uesyygsila) View more
NCT03740165 (MK-7339-001 \| KEYLYNK-001 \| GOG-3036 \| ENGOT-ov43, CTgov)	Phase 3	Primary peritoneal carcinoma \| BRCA-mutated Ovarian Cancer \| Platinum-Resistant Primary Peritoneal Carcinoma ... View more	1,367	Olaparib+Carboplatin+Paclitaxel+Docetaxel+Pembrolizumab+Bevacizumab (Carboplatin + Paclitaxel + Pembrolizumab + Olaparib)	pnofnurbvf(jhnamkfbos) = bhbogfvgvi hiyrburyhx (watbfcbalh, ayzmowdzso - znyxqbuaat) View more	-	12 Sep 2025
				Placebo for olaparib+Carboplatin+Paclitaxel+Docetaxel+Pembrolizumab+Bevacizumab (Carboplatin + Paclitaxel + Pembrolizumab)	pnofnurbvf(jhnamkfbos) = tupsprqlzn hiyrburyhx (watbfcbalh, kgumbcakab - poycmzdyql) View more
WCLC2025	Phase 2/3	Malignant Pleural Mesothelioma	440	Chemotherapy + Pembrolizumab	ldakkfwkdq(arnveyfbrs): HR = 0.85 (95.0% CI, 0.67 - 1.08) View more	Positive	09 Sep 2025
				Chemotherapy

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis