{"id":"us-keytruda","safety":{"commonSideEffects":[{"rate":"30-40","effect":"Fatigue"},{"rate":"20-30","effect":"Diarrhea"},{"rate":"20-30","effect":"Nausea"},{"rate":"15-25","effect":"Decreased appetite"},{"rate":"3-5","effect":"Immune-related pneumonitis"},{"rate":"2-5","effect":"Immune-related hepatitis"},{"rate":"2-4","effect":"Immune-related colitis"}]},"_chembl":{"chemblId":"CHEMBL2109615","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"By inhibiting the PD-1 checkpoint, the drug prevents tumor cells from suppressing T cell activity. This allows the immune system to recognize and attack cancer cells more effectively. The mechanism is similar to other PD-1 inhibitors used in immuno-oncology.","oneSentence":"US-Keytruda is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:53:14.050Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic melanoma"},{"name":"Non-small cell lung cancer"},{"name":"Head and neck squamous cell carcinoma"},{"name":"Hodgkin lymphoma"},{"name":"Urothelial carcinoma"}]},"trialDetails":[{"nctId":"NCT06687369","phase":"PHASE3","title":"A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)","status":"RECRUITING","sponsor":"mAbxience Research S.L.","startDate":"2024-12-30","conditions":"Non Squamous Non Small Cell Lung Cancer","enrollment":726},{"nctId":"NCT07160335","phase":"PHASE1","title":"A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors","status":"RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2025-09-26","conditions":"Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma","enrollment":174},{"nctId":"NCT06153238","phase":"PHASE1","title":"A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sandoz","startDate":"2024-05-15","conditions":"Melanoma","enrollment":322},{"nctId":"NCT06311721","phase":"PHASE3","title":"A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2024-09-09","conditions":"Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer","enrollment":315},{"nctId":"NCT07180862","phase":"PHASE1","title":"A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants","status":"RECRUITING","sponsor":"Bio-Thera Solutions","startDate":"2025-10-14","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":140},{"nctId":"NCT06280196","phase":"PHASE3","title":"A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC","status":"TERMINATED","sponsor":"Bio-Thera Solutions","startDate":"2024-07-19","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":162},{"nctId":"NCT03319940","phase":"PHASE1","title":"Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2017-12-26","conditions":"Small Cell Lung Carcinoma","enrollment":269},{"nctId":"NCT06847334","phase":"PHASE3","title":"A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2025-04-27","conditions":"Non-Squamous Non-Small Cell Lung Cancer","enrollment":772},{"nctId":"NCT06173011","phase":"PHASE1","title":"A Study Comparing Pharmacokinetic and Safety of QL2107 and Keytruda® (Marketed in China and the United States) in Healthy Adults","status":"UNKNOWN","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2023-12-12","conditions":"Tumor","enrollment":168}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pembrolizumab Injection"],"phase":"phase_3","status":"active","brandName":"US-Keytruda®","genericName":"US-Keytruda®","companyName":"Bio-Thera Solutions","companyId":"bio-thera-solutions","modality":"Small molecule","firstApprovalDate":"","aiSummary":"US-Keytruda is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses. Used for Metastatic melanoma, Non-small cell lung cancer, Head and neck squamous cell carcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}