Delving into the Latest Updates on Pembrolizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

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

+ [12]

Target

PD-1

Action

inhibitors

Mechanism

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

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [12]

Active Indication

Fallopian Tube CarcinomaNon-Muscle Invasive Bladder NeoplasmsOvarian Epithelial Carcinoma+ [321]

Inactive Indication

Acral Lentiginous Malignant MelanomaAcute Myeloid LeukemiaAcute myeloid leukemia with mutated NPM1+ [128]

Originator Organization

Merck & Co., Inc.

Active Organization

Merck Sharp & Dohme Corp.

MSD R&D (China) Co. Ltd.Merck Sharp & Dohme BV

+ [17]

Inactive Organization

Merck Sharp & Dohme (Ireland) Ltd.

Turnstone Biologics Corp.

Eisai GmbH

+ [1]

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), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (China)

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Structure/Sequence

Sequence Code 93660H

Source: *****

Sequence Code 93670L

Source: *****

Gastric/GEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric/GEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin 18.2 (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.

Start Date30 Jun 2027

Sponsor / Collaborator

Transcenta Therapeutics Co., Limited

NCT04266730

/ SuspendedPhase 1

Phase I Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Administered Concurrently With Pembrolizumab

This is a single center, open-label phase I clinical trial designed to determine the safety of personalized and adjusted neoantigen peptide vaccine (PANDA-VAC) administered concurrently with pembrolizumab in subjects with advanced squamous non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (SCCHN).

Start Date20 May 2027

Sponsor / Collaborator

Lineberger Comprehensive Cancer Center

NCT07843550

/ Not yet recruitingPhase 1/2

A Phase 1/2 Trial Of Larotrectinib And Pembrolizumab In Patients With Solid Tumors Previously Treated With Immune Checkpoint Inhibitor Monotherapy

This is a single-center, open-label Phase 1/2 trial evaluating the safety and efficacy of the combination of larotrectinib and pembrolizumab in patients with advanced/metastatic lung adenocarcinoma or melanoma.

Start Date01 Mar 2027

Sponsor / Collaborator

M.D. Anderson International España SA

100 Clinical Results associated with Pembrolizumab

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100 Translational Medicine associated with Pembrolizumab

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100 Patents (Medical) associated with Pembrolizumab

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11,173

Literatures (Medical) associated with Pembrolizumab

31 Dec 2026·Human Vaccines & Immunotherapeutics

Durable response of anaplastic thyroid cancer to pembrolizumab combined with chemotherapy: A case report

Article

Author: Zhuang, Yihan ; Chen, Qiongshan ; Lin, Wen ; Chen, Zipei

Anaplastic thyroid cancer is a notoriously aggressive malignancy with a dismal prognosis, typically associated with a median overall survival of less than one year. Therapeutic alternatives are particularly limited for patients without actionable driver mutations. Here, we report a case of BRAF V600E wild-type, PD-L1-positive (tumor proportion score of 80%) anaplastic thyroid cancer with residual/relapsed disease following surgery and subsequent progression on multi-targeted tyrosine kinase inhibitor therapy. The patient was thereafter treated with a combination of pembrolizumab, nab-paclitaxel and carboplatin, resulting in a sustained near-complete response lasting over 30 months, accompanied by a manageable safety profile. The favorable response in this case suggests that further evaluation of this triplet regimen could be considered for anaplastic thyroid cancer, though this remains a speculative premise requiring validation. Further studies are also needed to clarify the underlying mechanisms of this combination and to identify predictive biomarkers for patient selection.

31 Dec 2026·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Focused ultrasound ablation surgery combined with immune checkpoint inhibition in driver-gene wild-type NSCLC with liver metastasis: a feasibility study

Article

Author: Wang, Ting ; Chen, Jinyun ; Ouyang, Bing ; Chen, Li ; Chen, Wenzhi

BACKGROUND:

This single-arm, open-label clinical trial aimed to evaluate the preliminary safety, efficacy and feasibility of focused ultrasound ablation surgery (FUAS) sequential with immune checkpoint inhibitors (ICIs) in patients with driver-gene wild-type non-small cell lung cancer (NSCLC) and liver metastases.

MATERIALS AND METHODS:

Ten eligible patients received two cycles of FUAS sequential with ICIs. The ICIs used include Camrelizumab (7/10), Pembrolizumab (3/10) and Serplulimab used for immune rechallenge (1/10). Follow-up was conducted every 6 weeks ± 3 days, including imaging and hematological assessments. Treatment-related adverse events (AEs) were documented anytime.

RESULTS:

All participants demonstrated stable tolerability and safety in this trial. Immediate post-FUAS ablation rates ranged from 73% to 80%. The median follow-up time is 84 days (IQR, 42-127 days). From baseline to week 18, continuous shrinkage of both hepatic metastatic and target lesions was observed. The DCR of the tumor has reached 80% since the 2nd follow-up (12 weeks), and it remains at 50% until the 4th follow-up (24 weeks).

CONCLUSION:

FUAS sequential with ICIs suggests preliminary safety, activity and feasibility in treating driver-gene wild-type NSCLC patients with liver metastases, further validation is needed.

31 Dec 2026·OncoImmunology

A mixed inflammatory peripheral signature defines clinical outcomes in a phase II trial combining pembrolizumab with paclitaxel and carboplatin in melanoma

Article

Author: Cocolakis, Eftihia ; Cailhier, Jean-François ; Lapointe, Réjean ; Thébault, Paméla ; Shechtman, Yelena ; Lepage, Stéphanie ; Letendre, Caroline ; Le, Huy ; Dionne, Jeanne ; Bélanger, Karl ; Jamal, Rahima ; Lambert, Caroline ; Miller Jr, Wilson H.

Checkpoint blockade of PD-1 with pembrolizumab provides long-term survival to a significant proportion of patients with metastatic melanoma. Pembrolizumab has been successfully used in combination with chemotherapy in non-small-cell lung cancer to increase the response rate. This phase II trial combined pembrolizumab with carboplatin/paclitaxel (CP) to assess its safety and efficacy, and to identify correlates of responses. Thirty patients without prior immunotherapy for unresectable/metastatic melanoma were treated with pembrolizumab and CP. Peripheral blood was collected at baseline and after 2 cycles to characterize systemic immune activity by multiplex assays and flow cytometry. Seventy percent of patients received all 4 cycles of CP; 87% received pembrolizumab for 2 y or until progression. Grade 3 and higher adverse events (AEs) occurred in 50% of the patients. The overall response rate (ORR) and disease control rate (DCR) by irRC criteria were 43% and 53%, respectively. Median overall survival (OS) was 23.8 months. Objective response was associated with a lower frequency of naive CD8 T cells and low plasma CCL3 at baseline, along with a larger proportion of mature NK cells and of CD4 T cells expressing BTLA or LAIR-1. Survival rate was higher for patients with lower baseline of IL-6, IL-8, and CD4⁺CD39⁺ T cells. Following treatment, pro-inflammatory soluble factors increased in both responders and non-responders. Addition of CP to pembrolizumab in this study did not appear to result in a response or survival advantage and was less tolerable than immunotherapy alone. Correlative data point to peripheral signals to investigate further as potential biomarkers. Trial registration: clinicaltrials.gov, NCT02617849, registered on December 1st, 2015.

7,274

News (Medical) associated with Pembrolizumab

23 Oct 2026

·www.prnewswire.com

Rakuten Medical Presents Long-Term Follow-up Results of ASP-1929 Photoimmunotherapy in Combination with Pembrolizumab for R/M HNSCC at ESMO 2026

Median DOR of 44.3 months supports durability of response 4-year overall survival rate of 35.3% and median OS of 28.2 months suggest meaningful long-term survival Long-term survival of 42+ - 60+ months observed among complete responders SAN DIEGO, Oct. 23, 2026 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox® platform-based photoimmunotherapy, today announced the presentation of long-term follow-up results from the Phase 1b/2 ASP-1929-181 study (NCT04305795), which evaluated ASP-1929 photoimmunotherapy in combination with pembrolizumab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (r/m HNSCC), at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. The data were presented as an e-poster on October 23, 2026 at 8:00 a.m. (CET). Prior efficacy and safety findings from the ASP-1929-181 study showed durable clinical activity and a manageable safety profile after a median follow-up of 31.7 months. The current analysis extends follow-up by an additional 21.4 months to a median follow-up of 53.1 months and reports updated efficacy and safety outcomes, along with exploratory subgroup analyses by HPV status, PD-L1 CPS expression, and tumor size at baseline. ASP-1929-181 Study Presentation at ESMO 2026 Title: Long-Term Results of ASP-1929 Photoimmunotherapy with Pembrolizumab in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Poster: View/Download Poster [PDF] Key Findings (Data cutoff: February 10, 2026): The ASP-1929-181 study enrolled 19 patients with r/m HNSCC, and the long-term follow-up analysis included 17 efficacy-evaluable patients. Meaningful long-term survival was observed: Median overall survival (OS) was 28.2 months. Estimated OS rates were 47.1% at 36 months and 35.3% at 48 months. Among five (29%) patients who achieved a complete response (CR), four remained alive with follow-up ranging from more than 42 months to more than 60 months. Durability of response was suggested by: Median duration of response (DOR) was 44.3 months at the data cutoff. Four responders remained free from subsequent anticancer therapy following discontinuation of study treatment. Exploratory analyses showed generally consistent efficacy and safety findings across subgroups defined by baseline HPV status, PD-L1 CPS expression, and tumor size. No new safety signals were observed. Rakuten Medical is currently conducting the global Phase 3 ASP-1929-381 study (NCT06699212) evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC. These findings are exploratory and should be interpreted in light of the study's limitations, including the small sample size and limited patient numbers in some subgroup analyses. Nevertheless, the results support continued investigation of the ASP-1929-381 study. Following completion of this trial, Rakuten Medical aims to submit a Biologics License Application (BLA) for ASP-1929 to the U.S. FDA in 2028. About Alluminox® platform The Alluminox platform is Rakuten Medical's investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye® 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical's pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational. About ASP-1929 Rakuten Medical's first pipeline drug developed on its Alluminox® platform is ASP-1929, an antibody-dye conjugate comprised of the anti-epidermal growth factor receptor (EGFR) antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to EGFR, a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority. About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox® platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit our website, LinkedIn and YouTube. Investor Contact: Abhijit Bhatia Chief Operating Officer Tel: +1-619-650-1549 Email: [email protected] Media Contact: Ai Yoshikawa Associate Director, Global Corporate Communications Tel: +81-(0)70-4196-0845 Email: [email protected] Contact Us SOURCE Rakuten Medical, Inc. 21% more press release views with Request a Demo

ImmunotherapyClinical ResultPhase 3Drug Approval

23 Oct 2026

·www.biospace.com

Sofusa® Holdings Relaunches as Independent Company to Advance Lymphatic Drug Delivery

Precision lymphatic targeting platform validated with clinical data in both Rheumatoid Arthritis and in Cancer; Class II Device FDA submission planned in Q2 2027. NEW YORK--(BUSINESS WIRE)--Sofusa Holdings today announced its launch as an independent, clinical-stage company pioneering the development of a proprietary nanotechnology platform for precision targeting of lymphatic vessels and lymph nodes. The company has restarted manufacturing and plans to develop a pipeline of combination biologic products for autoimmune diseases, cancer and potentially other disorders of the immune system. In early human proof-of-concept clinical studies, the company’s DoseConnect ® platform demonstrated the therapeutic impact of lymphatic drug delivery in rheumatoid arthritis and in refractory cutaneous lymphoma cancer patients. Sofusa plans to make its first FDA submission as a Class II device delivering biologic therapies intradermally for lymphatic uptake in Q2 2027. In an open-label, single-arm Phase 1b study (NCT04559412), 10 of 10 patients with moderate-to-severe rheumatoid arthritis who had not improved on the maximum weekly dose (50 mg) of subcutaneous etanercept demonstrated clinically meaningful improvement after switching to lymphatic delivery at half the dose (25 mg) — including a 70% reduction in tender joints, a 34% improvement in DAS28-ESR, and a 62% reduction in pain, with virtually no administration pain (VAS below 5 on a 0–100 scale). In a separate Phase 1b study in cutaneous T-cell lymphoma (CTCL) at City of Hope, two of three patients with advanced disease who had not responded to prior treatments responded to lymphatic delivery of pembrolizumab. In preclinical biodistribution studies, by delivering biologic therapies directly into the lymphatic system — where key immune targets reside — the platform achieved up to 80-fold higher drug concentrations in lymph nodes compared with conventional subcutaneous administration, with lower concentrations in off-target organs. Because DoseConnect can work with already-approved biologic medicines, the company expects these proven mechanisms to offer a more efficient development pathway, with shorter timelines and lower costs. In addition, the potential for lower doses due to increased lymphatic concentrations may enable better outcomes at lower cost. Novel immunotherapies such as bispecific antibodies or oncolytic virus therapies may also benefit from lymphatic delivery to enhance clinical response and reduce systemic toxicity. “By enabling clinicians to both visualize and treat the lymphatic system, we aim to reveal biology, improve therapeutic precision, and transform the treatment of immune-mediated diseases,” said Brian Cooley, Chief Executive Officer of Sofusa Holdings. “I returned to Sofusa because I saw patients improve with lymphatic delivery of medicines when nothing else had worked. Seeing what that could mean for patients and their families made the opportunity deeply personal. That is the promise we are building this company around.” The Sofusa platform was originally developed at Kimberly-Clark and advanced into clinical trials under Sorrento Therapeutics, benefiting from over ~$100M of cumulative investment. New investors acquired the rights and have launched Sofusa as an independent company to bring the platform to commercial reality. “After more than a decade of innovation and development within large organizations, Sofusa’s science and value proposition are ready to stand on their own,” said Akash Gupta, Chairman of Sofusa Holdings. “The lymphatics are an extensive vascular network central to fluid transport and adaptive immunity, yet historically difficult to observe and access. Sofusa’s platform is designed to access this network directly and deliver therapy directly into it — potentially requiring less drug to achieve more. That’s a fundamentally new approach to medicine with the potential to transform treatment across autoimmune disease, oncology, and many other indications.” Sofusa will present at the MedTech Strategist Innovation Summit San Diego 2026, held November 3–5 at The US Grant Hotel in San Diego, CA. Chief Executive Officer Brian R. Cooley will present on Wednesday, November 4, 2026, at 11:40 a.m. PT. Members of the Sofusa executive leadership team will be available for one-on-one partnering meetings with strategic partners and biopharmaceutical executives throughout the summit. About Sofusa Holdings Sofusa Holdings is a clinical-stage technology platform company developing investigational tools for lymphatic imaging and targeted drug delivery. Its DoseConnect ® platform uses nanotopography-draped microneedles to enable absorption of biologic therapies directly into the lymphatic system. Sofusa’s products are investigational and have not been approved or cleared by the FDA. Forward-Looking Statements This press release contains forward-looking statements, including statements about Sofusa’s development and commercialization plans, the potential benefits of its platform, anticipated regulatory submissions and potential collaborations. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including clinical study results, regulatory review, manufacturing, financing and partnering. Sofusa undertakes no obligation to update these statements except as required by law. Contacts Media & Investor Contact: media@sofusa.com | Website:

Phase 1ImmunotherapyClinical Result

22 Oct 2026

·firstwordpharma.com

ESMO26: Moderna shares slide after leaked data for Merck & Co.-partnered cancer vaccine

Merck & Co. and Moderna's closely watched personalised cancer vaccine has posted survival data at the upper end of what investors had been hoping for, cutting the risk of recurrence or death by 42% when added to Keytruda (pembrolizumab) in a Phase III melanoma trial.However, detailed findings from the INTerpath-001 study of intismeran autogene (V940/mRNA-4157) came earlier than expected — two days ahead of a planned presentation at the upcoming European Society for Medical Oncology (ESMO) conference — after they were reportedly leaked by a third party, appearing to rattle investors. Moderna's stock plunged more than 17% on Thursday, while Merck shares ticked down close to 2%.Data meets benchmarkDespite the negative market reaction to the leaked data, the INTerpath-001 results seems to have met analyst expectations. Prior to the readout, Morgan Stanley analysts had said key opinion leaders and investors were hoping intismeran would be associated with a risk reduction close to 40% (see – Spotlight On: ESMO Preview — A new hope for cancer vaccines?).The mRNA-based neoantigen therapy, which Merck and Moderna are co-developing, is designed to turn each patient's tumour mutations into a personalised weapon against their cancer, training the immune system to recognise and attack cancer cells bearing those mutations.Toplined in August, the 1137-patient trial evaluated intismeran plus Keytruda against Keytruda alone as an adjuvant treatment for people with completely resected stage IIB-IV melanoma. The results were billed as a "landmark moment" by the study's principal investigator (see – Spotlight On: mRNA breaks from vaccine stable as Moderna, Merck & Co. deliver breakthrough melanoma results and Vital Signs: Merck & Co. enters Moderna's latest vaccine bubble).OS remains immatureAt a median follow-up of 24.6 months, the combination significantly improved the primary endpoint of recurrence-free survival (RFS), with a hazard ratio of 0.58 (p<0.001), according to data presented at ESMO. RFS rates were 82.2% versus 70% for the intismeran combo and Keytruda monotherapy groups, respectively.The combination also reduced the risk of distant metastasis or death by 38% (HR 0.62; p=0.002), a key secondary goal, with respective distant metastasis-free survival rates of 88.5% versus 80.2%. Researchers said benefits were observed across most subgroups."This is the first Phase III study to show that a treatment built from the unique 'fingerprint' of a patient's own tumour can reduce the risk of recurrence or death from cancer," said lead author Georgina Long. However, overall survival (OS) data are still too early to call. At this interim analysis, OS showed a hazard ratio of 0.77, which wasn't statistically significant. "Longer follow-up is needed to determine whether the reduction in recurrence translates into a survival benefit," researchers said.The efficacy gains came with a higher rate of discontinuation due to treatment-related adverse events (TRAEs) for either part of the cancer vaccine combo compared with Keytruda monotherapy (14% vs 8.7%), but grade 3-5 TRAEs were relatively similar between the two respective groups (14.2% vs 13.4%).Eight deaths due to adverse events were reported in the combination arm versus none in the control group, although five occurred before patients received their first vaccine dose, with two of those tied to Keytruda. Of the three deaths that occurred after the first dose of intismeran, none were attributed to study treatment.Inflated expectations?Some analysts suggested that investor expectations may have been elevated. "We assert this relative reduction in recurrence/death is clinically meaningful," stated Evan Seigerman of BMO Capital Markets, adding that the market reaction "likely reflects inflated expectations into the full data release, rather than a true indictment on the efficacy of the combo therapy."UBS echoed the sentiment, calling the INTerpath-001 results "overall a strong data set" that gives more confidence in upcoming studies of the vaccine in kidney and bladder cancers. Three Phase II/III readouts in renal, bladder and non–small-cell lung cancer could land before the end of 2027, part of a programme testing intismeran in six tumour types.Analysts at Barclays have said they expect intismeran could generate sales from melanoma prescriptions of about $3 billion by 2035.

VaccineClinical ResultPhase 3mRNA

100 Deals associated with Pembrolizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D10574	Pembrolizumab	L01FF02	DB09037

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	Australia	Merck Sharp & Dohme (Australia) Pty Ltd.	23 Jul 2026
Non-Muscle Invasive Bladder Neoplasms	Australia	Merck Sharp & Dohme (Australia) Pty Ltd.	23 Jul 2026
Carcinoma of urinary bladder, invasive	European Union	Merck Sharp & Dohme BV	01 Jul 2026
Carcinoma of urinary bladder, invasive	Iceland	Merck Sharp & Dohme BV	01 Jul 2026
Carcinoma of urinary bladder, invasive	Liechtenstein	Merck Sharp & Dohme BV	01 Jul 2026
Carcinoma of urinary bladder, invasive	Norway	Merck Sharp & Dohme BV	01 Jul 2026
Platinum-Resistant Fallopian Tube Carcinoma	China	Merck Sharp & Dohme LLC	23 Jun 2026
Platinum-Resistant Primary Peritoneal Carcinoma	European Union	Merck Sharp & Dohme BV	22 Apr 2026
Platinum-Resistant Primary Peritoneal Carcinoma	Iceland	Merck Sharp & Dohme BV	22 Apr 2026
Platinum-Resistant Primary Peritoneal Carcinoma	Liechtenstein	Merck Sharp & Dohme BV	22 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma	European Union	Merck & Co., Inc.	02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma	Iceland	Merck & Co., Inc.	02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma	Liechtenstein	Merck & Co., Inc.	02 Apr 2026
Platinum-Resistant Epithelial Ovarian Carcinoma	Norway	Merck & Co., Inc.	02 Apr 2026
Mismatch repair-deficient Colonic Cancer	United States	Merck Sharp & Dohme Corp.	10 Feb 2026
Mismatch repair-deficient Colonic Cancer	United States	Merck Sharp & Dohme LLC	10 Feb 2026
Neoplasms	United States	Merck Sharp & Dohme Corp.	10 Feb 2026
Neoplasms	United States	Merck Sharp & Dohme LLC	10 Feb 2026
Ovarian Cancer	United States	Merck Sharp & Dohme LLC	10 Feb 2026
Ovarian Cancer	United States	Merck Sharp & Dohme Corp.	10 Feb 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
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
Non-small cell lung cancer stage I	Phase 3	United States	Merck Sharp & Dohme LLC	04 May 2026
Non-small cell lung cancer stage I	Phase 3	Japan	Merck Sharp & Dohme LLC	04 May 2026
Non-small cell lung cancer stage I	Phase 3	Australia	Merck Sharp & Dohme LLC	04 May 2026
Non-small cell lung cancer stage I	Phase 3	Brazil	Merck Sharp & Dohme LLC	04 May 2026
Non-small cell lung cancer stage I	Phase 3	Canada	Merck Sharp & Dohme LLC	04 May 2026
Non-small cell lung cancer stage I	Phase 3	Chile	Merck Sharp & Dohme LLC	04 May 2026
Non-small cell lung cancer stage I	Phase 3	Colombia	Merck Sharp & Dohme LLC	04 May 2026
Non-small cell lung cancer stage I	Phase 3	France	Merck Sharp & Dohme LLC	04 May 2026

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02617849 (Pubmed \| Oncoimmunology)	Phase 2	Melanoma	30	Pembrolizumab and Carboplatin/ Paclitaxel	twbfmkmnan(slqjvjwnpo) = gnsditixjo pahlcnyrdz (hsemwyvkql ) View more	Negative	31 Dec 2026
ACR2026	Not Applicable	Renal Cell Carcinoma	27,394	ICI (RA)	lsvcrysvvx(isberzpvfb) = szowuwrcpf oagjqrqmap (pedzkalqxl ) View more	Positive	06 Nov 2026
				ICI (non-RA)	lsvcrysvvx(isberzpvfb) = xzrjqiqobh oagjqrqmap (pedzkalqxl ) View more
NCT03598608 (MK-4280-003, Pubmed \| Blood Neoplasia)	Phase 1/2	Refractory Classic Hodgkin Lymphoma PD-1	34	Favezelimab 800 mg plus Pembrolizumab 200 mg	miuhtgxjgk(vsnzfisvpf) = 1 of 21 participants experienced a dose-limiting toxicity (grade 4 autoimmune hepatitis) ozlfnxseso (frzorcxppl ) View more	Positive	01 Nov 2026
ESMO2026	Not Applicable	PD-L1 positive Triple Negative Breast Cancer First line PD-L1-positive \| ER Negative \| PR Negative ... View more	177	Pembrolizumab plus chemotherapy (Normal weight)	kawldhitwr(tizyxhylyl) = uaclyuvxcl xgqszawueo (hjqusiprri ) View more	Positive	23 Oct 2026
				Pembrolizumab plus chemotherapy (Overweight)	kawldhitwr(tizyxhylyl) = wygkdgxaok xgqszawueo (hjqusiprri ) View more
ESMO2026	Phase 3	Recurrent Squamous Cell Carcinoma of the Head and Neck First line	3,918	Pembrolizumab plus chemotherapy	-	Positive	23 Oct 2026
				Pembrolizumab
NCT03924856 (KEYNOTE-866, ESMO2026)	Phase 3	Muscle Invasive Bladder Carcinoma Neoadjuvant	907	Neoadjuvant pembrolizumab + gemcitabine + cisplatin	soqcbwddlt(trvdopfdoj) = tfkchbahga kopcporkwf (illzaesffa ) View more	Negative	23 Oct 2026
				Neoadjuvant placebo + gemcitabine + cisplatin	soqcbwddlt(trvdopfdoj) = bqjtbqzyga kopcporkwf (illzaesffa ) View more
NCT03833167 (KEYNOTE-630, ESMO2026)	Phase 3	Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck Adjuvant	450	Pembrolizumab	ucbeievaax(gigwguthrz) = adzsrqcrwz ntnoorlngx (chdtvqpzsd ) View more	Negative	23 Oct 2026
				Placebo	ucbeievaax(gigwguthrz) = ojpsdjxhdo ntnoorlngx (chdtvqpzsd ) View more
ESMO2026	Not Applicable	Non-Small Cell Lung Cancer First line	333	Pembrolizumab ± chemotherapy	umdfnmqfyr(ncgcbdpivs) = njmcpgvery nnqqwlntie (vwmumkfsxp ) View more	Positive	23 Oct 2026
				Pembrolizumab ± chemotherapy (Group O)	-
ESMO2026	Not Applicable	Merkel Cell Carcinoma	21	Pembrolizumab	wyrkkpwmsm(lxhcufoxxu) = vuvhznbppu gbihaoydqj (dhoydzywod ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Lung Cancer \| Breast Cancer Neoadjuvant	144	pembrolizumab 200 mg (Triple-Negative Breast Cancer (TNBC))	hvbzkhegwe(shrhcikxys) = laugutncgs gqzbnpcydj (rtwvbaxkbc ) View more	Positive	23 Oct 2026
				pembrolizumab 2 mg/kg (NSCLC)	hvbzkhegwe(shrhcikxys) = dvbehabetw gqzbnpcydj (rtwvbaxkbc ) View more

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Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

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Accelerate your research with the latest regulatory approval information.

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.

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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.

Regulation

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

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

Pembrolizumab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation