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planned","href":"/trials/nct07256964/"},{"record":"nct06717464","field":"status","kind":"trial","state":"development","label":"Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer: phase 2, active","href":"/trials/nct06717464/"},{"record":"nct06441344","field":"status","kind":"trial","state":"development","label":"Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell: phase 3, planned","href":"/trials/nct06441344/"},{"record":"nct06903858","field":"status","kind":"trial","state":"development","label":"Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer: phase 2, recruiting","href":"/trials/nct06903858/"},{"record":"nct07819578","field":"status","kind":"trial","state":"development","label":"Toripalimab Plus Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable NSCLC: phase 2, planned","href":"/trials/nct07819578/"},{"record":"registry:toripalimab","kind":"registry","state":"development","label":"ClinicalTrials.gov: 56 recruiting, active or planned studies (fetched 2026-09-28)","href":"/drugs/toripalimab/#registry"}],"reasons":[{"drugId":"cemiplimab","drugName":"Cemiplimab","drugRoute":"/drugs/cemiplimab/","drugState":"approved","record":"fianlimab-phase3-melanoma","kind":"trial","label":"Fianlimab + cemiplimab phase 3 (first-line melanoma): phase 3, negative","href":"/trials/fianlimab-phase3-melanoma/","quote":"Primary PFS endpoint not met; numerical +5.1 months median PFS at the high dose."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"nivolumab","kind":"event","label":"US 2020-12-29: withdrawal","href":"/drugs/nivolumab/","quote":"Withdrawn: the indication came off the label 2.4 years after its accelerated approval."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"nivolumab","kind":"event","label":"US 2021-07-23: withdrawal","href":"/drugs/nivolumab/","quote":"Withdrawn: the indication came off the label 3.8 years after its accelerated approval."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-026","kind":"trial","label":"CheckMate 026: phase 3, negative","href":"/trials/checkmate-026/","quote":"Median progression-free survival 4.2 against 5.9 months (hazard ratio 1.15, p=0.25) and overall survival 14.4 against 13.2 months (hazard ratio 1.02): the primary endpoint was not met."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-143","kind":"trial","label":"CheckMate 143: phase 3, negative","href":"/trials/checkmate-143/","quote":"OS 9.8 vs 10.0 months, HR 1.04 (95% CI 0.83-1.30); no benefit."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-498","kind":"trial","label":"CheckMate 498: phase 3, negative","href":"/trials/checkmate-498/","quote":"OS 13.4 vs 14.9 months, HR 1.31 (95% CI 1.09-1.58); worse with nivolumab."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-548","kind":"trial","label":"CheckMate 548: phase 3, negative","href":"/trials/checkmate-548/","quote":"OS 28.9 vs 32.1 months, HR 1.1 (95% CI 0.9-1.3); no PFS or OS benefit."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-915","kind":"trial","label":"CheckMate 915: phase 3, negative","href":"/trials/checkmate-915/","quote":"Nivolumab plus low-dose ipilimumab did not improve recurrence-free survival over nivolumab alone after resection of stage III to IV melanoma."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"lung-map-s1400i","kind":"trial","label":"Lung-MAP S1400I: nivolumab with or without ipilimumab: phase 3, negative","href":"/trials/lung-map-s1400i/","quote":"Nivolumab plus ipilimumab did not improve survival over nivolumab alone; the trial closed for futility."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"relativity-098","kind":"trial","label":"RELATIVITY-098: phase 3, negative","href":"/trials/relativity-098/","quote":"RFS not improved."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"tinivo-2","kind":"trial","label":"TiNivo-2: phase 3, negative","href":"/trials/tinivo-2/","quote":"PFS HR 1.10; no benefit from nivolumab rechallenge."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"pembrolizumab","kind":"event","label":"US 2021-03-30: withdrawal","href":"/drugs/pembrolizumab/","quote":"Withdrawn: the indication came off the label 1.8 years after its accelerated approval."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"pembrolizumab","kind":"event","label":"US 2022-02-04: withdrawal","href":"/drugs/pembrolizumab/","quote":"Withdrawn: the indication came off the label 4.4 years after its accelerated approval."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"impassion030","kind":"trial","label":"ALEXANDRA / IMpassion030: phase 3, negative","href":"/trials/impassion030/","quote":"iDFS HR 1.11 (0.87 to 1.42), p 0.38; stopped for futility at 2,199 of 2,300 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0.057); CPS 1 or more 10.7 vs 10.2 (HR 0.86); all patients 9.9 vs 10.8 (HR 0.97). Negative."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-412","kind":"trial","label":"KEYNOTE-412: phase 3, negative","href":"/trials/keynote-412/","quote":"Pembrolizumab added to chemoradiotherapy did not significantly improve event-free survival."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-641","kind":"trial","label":"KEYNOTE-641: phase 3, negative","href":"/trials/keynote-641/","quote":"Median overall survival 24.7 against 27.3 months (hazard ratio 1.04, 95 percent confidence interval 0.88 to 1.22) and radiographic progression-free survival 10.4 against 9.0 months (0.98, 0.84 to 1.14); stopped for futility. Grade 3 or higher treatment-related adverse events 31.2 against 10.8 percent."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-921","kind":"trial","label":"KEYNOTE-921: phase 3, negative","href":"/trials/keynote-921/","quote":"Median radiographic progression-free survival 8.6 against 8.3 months (hazard ratio 0.85, 95 percent confidence interval 0.71 to 1.01) and overall survival 19.6 against 19.0 months (0.92, 0.78 to 1.09); neither endpoint met."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-991","kind":"trial","label":"KEYNOTE-991: phase 3, negative","href":"/trials/keynote-991/","quote":"Radiographic progression-free survival hazard ratio 1.20 (95 percent confidence interval 0.96 to 1.49, p=0.9467), medians not reached; stopped for futility. Grade 3 or higher adverse events 61.9 against 38.1 percent and rash 25.1 against 9.3 percent."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"leap-002","kind":"trial","label":"LEAP-002: phase 3, negative","href":"/trials/leap-002/","quote":"OS HR 0.84, not significant."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"litespark-012","kind":"trial","label":"LITESPARK-012: phase 3, negative","href":"/trials/litespark-012/","quote":"Primary endpoint not met (ASCO GU 2026)."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"nct05117242","kind":"trial","label":"Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer: phase 2, terminated or withdrawn","href":"/trials/nct05117242/","quote":"Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. 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Negative."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-412","kind":"trial","label":"KEYNOTE-412: phase 3, negative","href":"/trials/keynote-412/","quote":"Pembrolizumab added to chemoradiotherapy did not significantly improve event-free survival."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-641","kind":"trial","label":"KEYNOTE-641: phase 3, negative","href":"/trials/keynote-641/","quote":"Median overall survival 24.7 against 27.3 months (hazard ratio 1.04, 95 percent confidence interval 0.88 to 1.22) and radiographic progression-free survival 10.4 against 9.0 months (0.98, 0.84 to 1.14); stopped for futility. Grade 3 or higher treatment-related adverse events 31.2 against 10.8 percent."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-921","kind":"trial","label":"KEYNOTE-921: phase 3, negative","href":"/trials/keynote-921/","quote":"Median radiographic progression-free survival 8.6 against 8.3 months (hazard ratio 0.85, 95 percent confidence interval 0.71 to 1.01) and overall survival 19.6 against 19.0 months (0.92, 0.78 to 1.09); neither endpoint met."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-991","kind":"trial","label":"KEYNOTE-991: phase 3, negative","href":"/trials/keynote-991/","quote":"Radiographic progression-free survival hazard ratio 1.20 (95 percent confidence interval 0.96 to 1.49, p=0.9467), medians not reached; stopped for futility. 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no difference between arms on the interim analysis, per the registry; no publication (ClinicalTrials.gov NCT04447235)."},{"drugId":"sasanlimab","drugName":"Sasanlimab","drugRoute":"/drugs/sasanlimab/","drugState":"development","record":"sasanlimab","kind":"regional","label":"EMA / European Commission (EU): withdrawn","href":"https://www.ema.europa.eu/en/medicines/human/EPAR/zumrad","quote":"Zumrad with BCG for BCG-naive high-risk non-muscle-invasive bladder cancer: marketing authorisation application withdrawn by Pfizer 13 Feb 2026 before a CHMP opinion, after the CHMP questioned protocol and statistical changes made during the main study"},{"drugId":"alemtuzumab","drugName":"Alemtuzumab","drugRoute":"/drugs/alemtuzumab/","drugState":"approved","record":"alemtuzumab","kind":"regional","label":"EMA / European Commission (EU): withdrawn 2012","href":"https://www.ema.europa.eu/en/medicines/human/EPAR/mabcampath","quote":"MabCampath authorised 6 Jul 2001; marketing authorisation withdrawn at Genzyme's request 8 Aug 2012 (commercial reasons); patient access programmes continued nationally"},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"atezolizumab","kind":"event","label":"US 2021-04-13: withdrawal","href":"/drugs/atezolizumab/","quote":"Withdrawn: the indication came off the label 4.9 years after its accelerated approval."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"atezolizumab","kind":"event","label":"US 2021-08: withdrawal","href":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TECENTRIQ%22","quote":"Genentech withdrew the US TNBC indication after the confirmatory IMpassion131 trial (paclitaxel partner) showed no progression-free or overall survival benefit and the FDA's accelerated-approval review; the current Tecentriq label carries no breast cancer indication"},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"atezolizumab","kind":"event","label":"US 2021-08-27: withdrawal","href":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","quote":"TNBC indication withdrawn after IMpassion131"},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"atezolizumab","kind":"event","label":"US 2021-10-06: withdrawal","href":"https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-atezolizumab-pd-l1-positive-unresectable-locally-advanced-or-metastatic-triple-negative","quote":"Withdrawn: the indication came off the label 2.6 years after its accelerated approval."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"atezolizumab","kind":"event","label":"US 2022-12-02: withdrawal","href":"/drugs/atezolizumab/","quote":"Withdrawn: the indication came off the label 5.6 years after its accelerated approval."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"impassion030","kind":"trial","label":"ALEXANDRA / IMpassion030: phase 3, negative","href":"/trials/impassion030/","quote":"iDFS HR 1.11 (0.87 to 1.42), p 0.38; stopped for futility at 2,199 of 2,300 patients."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"contact-03","kind":"trial","label":"CONTACT-03: phase 3, negative","href":"/trials/contact-03/","quote":"PFS HR 1.03; OS HR 0.94, negative."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"gepardouze","kind":"trial","label":"GeparDouze / NSABP B-59: phase 3, negative","href":"/trials/gepardouze/","quote":"EFS HR 0.80 (0.62 to 1.03), p 0.083, not significant; OS HR 0.86 (0.62 to 1.19)."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"imbassador250","kind":"trial","label":"IMbassador250: phase 3, negative","href":"/trials/imbassador250/","quote":"Overall survival not improved: stratified hazard ratio 1.12 (95 percent confidence interval 0.91 to 1.37, p=0.28) for atezolizumab with enzalutamide against enzalutamide alone."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"imblaze370","kind":"trial","label":"IMblaze370: phase 3, negative","href":"/trials/imblaze370/","quote":"Median overall survival 8.87 months with atezolizumab and cobimetinib against 8.51 months with regorafenib (hazard ratio 1.00)."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"imbrave050","kind":"trial","label":"IMbrave050: phase 3, negative","href":"/trials/imbrave050/","quote":"Interim RFS HR 0.72; benefit not sustained at update."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"impassion131","kind":"trial","label":"IMpassion131: phase 3, negative","href":"/trials/impassion131/","quote":"PFS HR 0.82 (not significant); OS trend unfavourable; US indication withdrawn 2021."},{"drugId":"atezolizumab","drugName":"Atezolizumab","drugRoute":"/drugs/atezolizumab/","drugState":"approved","record":"neotrip","kind":"trial","label":"NeoTRIP (NeoTRIPaPDL1): phase 3, negative","href":"/trials/neotrip/","quote":"pCR 48.6% vs 44.4% (OR 1.18, p 0.48), not significant; EFS (primary) awaited."},{"drugId":"bevacizumab","drugName":"Bevacizumab","drugRoute":"/drugs/bevacizumab/","drugState":"approved","record":"bevacizumab","kind":"event","label":"US 2011-11-18: withdrawal","href":"/drugs/bevacizumab/","quote":"Withdrawn: the indication came off the label 3.7 years after its accelerated approval."},{"drugId":"bevacizumab","drugName":"Bevacizumab","drugRoute":"/drugs/bevacizumab/","drugState":"approved","record":"calgb-90401","kind":"trial","label":"CALGB 90401: phase 3, negative","href":"/trials/calgb-90401/","quote":"Median overall survival 22.6 against 21.5 months (hazard ratio 0.91, 95 percent confidence interval 0.78 to 1.05, p=0.181) despite progression-free survival 9.9 against 7.5 months and response 49.4 against 35.5 percent; treatment-related deaths 4.0 against 1.2 percent."},{"drugId":"bevacizumab","drugName":"Bevacizumab","drugRoute":"/drugs/bevacizumab/","drugState":"approved","record":"herby","kind":"trial","label":"HERBY: phase 2, negative","href":"/trials/herby/","quote":"Bevacizumab added to radiotherapy and temozolomide did not improve event-free survival in newly diagnosed paediatric high-grade glioma."},{"drugId":"bevacizumab-glioma","drugName":"Bevacizumab (glioblastoma use)","drugRoute":"/drugs/bevacizumab-glioma/","drugState":"approved","record":"avaglio","kind":"trial","label":"AVAglio: phase 3, negative","href":"/trials/avaglio/","quote":"Bevacizumab added to radiotherapy and temozolomide prolonged progression-free survival but not overall survival in newly diagnosed glioblastoma."},{"drugId":"bevacizumab-glioma","drugName":"Bevacizumab (glioblastoma use)","drugRoute":"/drugs/bevacizumab-glioma/","drugState":"approved","record":"checkmate-143","kind":"trial","label":"CheckMate 143: phase 3, negative","href":"/trials/checkmate-143/","quote":"OS 9.8 vs 10.0 months, HR 1.04 (95% CI 0.83-1.30); no benefit."},{"drugId":"camrelizumab","drugName":"Camrelizumab","drugRoute":"/drugs/camrelizumab/","drugState":"approved","record":"camrelizumab","kind":"event","label":"US 2024-05: complete response letter","href":"/drugs/camrelizumab/","quote":"Complete response letter for camrelizumab + rivoceranib in HCC (manufacturing/inspection)"},{"drugId":"camrelizumab","drugName":"Camrelizumab","drugRoute":"/drugs/camrelizumab/","drugState":"approved","record":"camrelizumab","kind":"event","label":"US 2025-03: complete response letter","href":"/drugs/camrelizumab/","quote":"Second complete response letter"},{"drugId":"camrelizumab-rivoceranib","drugName":"Camrelizumab + rivoceranib","drugRoute":"/drugs/camrelizumab-rivoceranib/","drugState":"approved","record":"camrelizumab-rivoceranib","kind":"event","label":"US 2024-05: complete response letter","href":"/drugs/camrelizumab-rivoceranib/","quote":"First CRL: manufacturing inspection findings"},{"drugId":"camrelizumab-rivoceranib","drugName":"Camrelizumab + rivoceranib","drugRoute":"/drugs/camrelizumab-rivoceranib/","drugState":"approved","record":"camrelizumab-rivoceranib","kind":"event","label":"US 2025-03: complete response letter","href":"/drugs/camrelizumab-rivoceranib/","quote":"Second CRL"},{"drugId":"camrelizumab-rivoceranib","drugName":"Camrelizumab + rivoceranib","drugRoute":"/drugs/camrelizumab-rivoceranib/","drugState":"approved","record":"camrelizumab-rivoceranib","kind":"event","label":"US 2026-07-23: complete response letter","href":"https://www.targetedonc.com/view/fda-passes-again-on-approving-rivoceranib-plus-camrelizumab-in-hcc","quote":"Third CRL, again cGMP"},{"drugId":"cemiplimab","drugName":"Cemiplimab","drugRoute":"/drugs/cemiplimab/","drugState":"approved","record":"fianlimab-phase3-melanoma","kind":"trial","label":"Fianlimab + cemiplimab phase 3 (first-line melanoma): phase 3, negative","href":"/trials/fianlimab-phase3-melanoma/","quote":"Primary PFS endpoint not met; numerical +5.1 months median PFS at the high dose."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"n0147","kind":"trial","label":"Alliance N0147: phase 3, negative","href":"/trials/n0147/","quote":"Three-year disease-free survival 71.5 with cetuximab against 74.6 percent without, in KRAS wild-type disease."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"de-escalate","kind":"trial","label":"De-ESCALaTE HPV: phase 3, negative","href":"/trials/de-escalate/","quote":"Severe toxicity similar; 2-year overall survival 97.5% (cisplatin) vs 89.4% (cetuximab)."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"coin","kind":"trial","label":"MRC COIN: phase 3, negative","href":"/trials/coin/","quote":"No overall survival gain from adding cetuximab to oxaliplatin-based first-line chemotherapy, including in KRAS wild-type disease."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"new-epoc","kind":"trial","label":"New EPOC: phase 3, negative","href":"/trials/new-epoc/","quote":"Median overall survival 55.4 months with cetuximab against 81.0 months without (hazard ratio 1.45)."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"petacc-8","kind":"trial","label":"PETACC-8: phase 3, negative","href":"/trials/petacc-8/","quote":"No disease-free survival benefit from cetuximab in KRAS wild-type disease (hazard ratio 1.05)."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"rtog-0617","kind":"trial","label":"RTOG 0617: phase 3, negative","href":"/trials/rtog-0617/","quote":"Median overall survival 28.7 months (60 Gy) vs 20.3 months (74 Gy); cetuximab no benefit."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"rtog-1016","kind":"trial","label":"RTOG 1016: phase 3, negative","href":"/trials/rtog-1016/","quote":"5-year overall survival 84.6% (cisplatin) vs 77.9% (cetuximab); non-inferiority not met."},{"drugId":"cosibelimab","drugName":"Cosibelimab","drugRoute":"/drugs/cosibelimab/","drugState":"approved","record":"cosibelimab","kind":"event","label":"US 2023-12: complete response letter","href":"/drugs/cosibelimab/","quote":"Complete response letter citing third-party manufacturing inspection findings"},{"drugId":"durvalumab","drugName":"Durvalumab","drugRoute":"/drugs/durvalumab/","drugState":"approved","record":"durvalumab","kind":"event","label":"US 2021-02-19: withdrawal","href":"/drugs/durvalumab/","quote":"Withdrawn: the indication came off the label 3.8 years after its accelerated approval."},{"drugId":"durvalumab","drugName":"Durvalumab","drugRoute":"/drugs/durvalumab/","drugState":"approved","record":"calla","kind":"trial","label":"CALLA: phase 3, negative","href":"/trials/calla/","quote":"Durvalumab added to chemoradiotherapy did not significantly improve progression-free survival in locally advanced cervical cancer."},{"drugId":"durvalumab","drugName":"Durvalumab","drugRoute":"/drugs/durvalumab/","drugState":"approved","record":"dream3r","kind":"trial","label":"DREAM3R: phase 3, negative","href":"/trials/dream3r/","quote":"Stopped early; primary endpoint not met."},{"drugId":"durvalumab","drugName":"Durvalumab","drugRoute":"/drugs/durvalumab/","drugState":"approved","record":"pacific-2","kind":"trial","label":"PACIFIC-2: phase 3, negative","href":"/trials/pacific-2/","quote":"Concurrent durvalumab with chemoradiotherapy did not significantly improve progression-free survival over chemoradiotherapy alone."},{"drugId":"ipilimumab","drugName":"Ipilimumab","drugRoute":"/drugs/ipilimumab/","drugState":"approved","record":"ca184-043-ipilimumab","kind":"trial","label":"CA184-043: phase 3, negative","href":"/trials/ca184-043-ipilimumab/","quote":"Median overall survival 11.2 against 10.0 months (hazard ratio 0.85, 95 percent confidence interval 0.72 to 1.00, p=0.053), missing significance; hazard ratio 1.46 in the first 5 months and 0.60 beyond 12 months. Grade 3 to 4 immune-related adverse events 26 against 3 percent, with four treatment-related deaths."},{"drugId":"ipilimumab","drugName":"Ipilimumab","drugRoute":"/drugs/ipilimumab/","drugState":"approved","record":"checkmate-915","kind":"trial","label":"CheckMate 915: phase 3, negative","href":"/trials/checkmate-915/","quote":"Nivolumab plus low-dose ipilimumab did not improve recurrence-free survival over nivolumab alone after resection of stage III to IV melanoma."},{"drugId":"ipilimumab","drugName":"Ipilimumab","drugRoute":"/drugs/ipilimumab/","drugState":"approved","record":"lung-map-s1400i","kind":"trial","label":"Lung-MAP S1400I: nivolumab with or without ipilimumab: phase 3, negative","href":"/trials/lung-map-s1400i/","quote":"Nivolumab plus ipilimumab did not improve survival over nivolumab alone; the trial closed for futility."},{"drugId":"margetuximab","drugName":"Margetuximab","drugRoute":"/drugs/margetuximab/","drugState":"approved","record":"margetuximab","kind":"regional","label":"EMA / European Commission (EU): withdrawn 2022","href":"/regulatory/regions/","quote":"MAA withdrawn 2022"},{"drugId":"necitumumab","drugName":"Necitumumab","drugRoute":"/drugs/necitumumab/","drugState":"approved","record":"necitumumab","kind":"regional","label":"EMA / European Commission (EU): withdrawn 2021","href":"https://www.ema.europa.eu/en/medicines/human/EPAR/portrazza","quote":"Portrazza authorised 15 Feb 2016; Lilly did not apply for renewal and the authorisation expired 18 Feb 2021 (lack of demand)"},{"drugId":"nimotuzumab","drugName":"Nimotuzumab","drugRoute":"/drugs/nimotuzumab/","drugState":"approved","record":"nimotuzumab","kind":"regional","label":"EMA / European Commission (EU): withdrawn","href":"https://www.ema.europa.eu/en/medicines/human/EPAR/theraloc","quote":"Theraloc (Oncoscience AG): marketing authorisation application withdrawn before a Commission decision. EMA register: 'Application withdrawn: The application for this medicine has been withdrawn'; checked 2026-09-24"},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"nivolumab","kind":"event","label":"US 2020-12-29: withdrawal","href":"/drugs/nivolumab/","quote":"Withdrawn: the indication came off the label 2.4 years after its accelerated approval."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"nivolumab","kind":"event","label":"US 2021-07-23: withdrawal","href":"/drugs/nivolumab/","quote":"Withdrawn: the indication came off the label 3.8 years after its accelerated approval."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-026","kind":"trial","label":"CheckMate 026: phase 3, negative","href":"/trials/checkmate-026/","quote":"Median progression-free survival 4.2 against 5.9 months (hazard ratio 1.15, p=0.25) and overall survival 14.4 against 13.2 months (hazard ratio 1.02): the primary endpoint was not met."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-143","kind":"trial","label":"CheckMate 143: phase 3, negative","href":"/trials/checkmate-143/","quote":"OS 9.8 vs 10.0 months, HR 1.04 (95% CI 0.83-1.30); no benefit."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-498","kind":"trial","label":"CheckMate 498: phase 3, negative","href":"/trials/checkmate-498/","quote":"OS 13.4 vs 14.9 months, HR 1.31 (95% CI 1.09-1.58); worse with nivolumab."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-548","kind":"trial","label":"CheckMate 548: phase 3, negative","href":"/trials/checkmate-548/","quote":"OS 28.9 vs 32.1 months, HR 1.1 (95% CI 0.9-1.3); no PFS or OS benefit."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-915","kind":"trial","label":"CheckMate 915: phase 3, negative","href":"/trials/checkmate-915/","quote":"Nivolumab plus low-dose ipilimumab did not improve recurrence-free survival over nivolumab alone after resection of stage III to IV melanoma."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"lung-map-s1400i","kind":"trial","label":"Lung-MAP S1400I: nivolumab with or without ipilimumab: phase 3, negative","href":"/trials/lung-map-s1400i/","quote":"Nivolumab plus ipilimumab did not improve survival over nivolumab alone; the trial closed for futility."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"relativity-098","kind":"trial","label":"RELATIVITY-098: phase 3, negative","href":"/trials/relativity-098/","quote":"RFS not improved."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"tinivo-2","kind":"trial","label":"TiNivo-2: phase 3, negative","href":"/trials/tinivo-2/","quote":"PFS HR 1.10; no benefit from nivolumab rechallenge."},{"drugId":"obinutuzumab","drugName":"Obinutuzumab","drugRoute":"/drugs/obinutuzumab/","drugState":"approved","record":"goya","kind":"trial","label":"GOYA: phase 3, negative","href":"/trials/goya/","quote":"Progression-free survival hazard ratio 0.92 (p = 0.39): no benefit over rituximab, with more grade 3 to 5 and fatal adverse events."},{"drugId":"ofatumumab","drugName":"Ofatumumab","drugRoute":"/drugs/ofatumumab/","drugState":"approved","record":"ofatumumab","kind":"regional","label":"EMA / European Commission (EU): withdrawn 2019","href":"https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra","quote":"Arzerra authorised 19 Apr 2010; marketing authorisation withdrawn at Novartis's request 28 Feb 2019 (commercial reasons)"},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"pembrolizumab","kind":"event","label":"US 2021-03-30: withdrawal","href":"/drugs/pembrolizumab/","quote":"Withdrawn: the indication came off the label 1.8 years after its accelerated approval."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"pembrolizumab","kind":"event","label":"US 2022-02-04: withdrawal","href":"/drugs/pembrolizumab/","quote":"Withdrawn: the indication came off the label 4.4 years after its accelerated approval."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"impassion030","kind":"trial","label":"ALEXANDRA / IMpassion030: phase 3, negative","href":"/trials/impassion030/","quote":"iDFS HR 1.11 (0.87 to 1.42), p 0.38; stopped for futility at 2,199 of 2,300 patients."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"fianlimab-phase3-melanoma","kind":"trial","label":"Fianlimab + cemiplimab phase 3 (first-line melanoma): phase 3, negative","href":"/trials/fianlimab-phase3-melanoma/","quote":"Primary PFS endpoint not met; numerical +5.1 months median PFS at the high dose."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"impassion131","kind":"trial","label":"IMpassion131: phase 3, negative","href":"/trials/impassion131/","quote":"PFS HR 0.82 (not significant); OS trend unfavourable; US indication withdrawn 2021."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-119","kind":"trial","label":"KEYNOTE-119: phase 3, negative","href":"/trials/keynote-119/","quote":"OS in CPS 10 or more 12.7 vs 11.6 months (HR 0.78, p 0.057); CPS 1 or more 10.7 vs 10.2 (HR 0.86); all patients 9.9 vs 10.8 (HR 0.97). Negative."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-412","kind":"trial","label":"KEYNOTE-412: phase 3, negative","href":"/trials/keynote-412/","quote":"Pembrolizumab added to chemoradiotherapy did not significantly improve event-free survival."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-641","kind":"trial","label":"KEYNOTE-641: phase 3, negative","href":"/trials/keynote-641/","quote":"Median overall survival 24.7 against 27.3 months (hazard ratio 1.04, 95 percent confidence interval 0.88 to 1.22) and radiographic progression-free survival 10.4 against 9.0 months (0.98, 0.84 to 1.14); stopped for futility. Grade 3 or higher treatment-related adverse events 31.2 against 10.8 percent."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-921","kind":"trial","label":"KEYNOTE-921: phase 3, negative","href":"/trials/keynote-921/","quote":"Median radiographic progression-free survival 8.6 against 8.3 months (hazard ratio 0.85, 95 percent confidence interval 0.71 to 1.01) and overall survival 19.6 against 19.0 months (0.92, 0.78 to 1.09); neither endpoint met."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-991","kind":"trial","label":"KEYNOTE-991: phase 3, negative","href":"/trials/keynote-991/","quote":"Radiographic progression-free survival hazard ratio 1.20 (95 percent confidence interval 0.96 to 1.49, p=0.9467), medians not reached; stopped for futility. Grade 3 or higher adverse events 61.9 against 38.1 percent and rash 25.1 against 9.3 percent."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"leap-002","kind":"trial","label":"LEAP-002: phase 3, negative","href":"/trials/leap-002/","quote":"OS HR 0.84, not significant."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"litespark-012","kind":"trial","label":"LITESPARK-012: phase 3, negative","href":"/trials/litespark-012/","quote":"Primary endpoint not met (ASCO GU 2026)."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"nct05117242","kind":"trial","label":"Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer: phase 2, terminated or withdrawn","href":"/trials/nct05117242/","quote":"Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns."},{"drugId":"pertuzumab","drugName":"Pertuzumab","drugRoute":"/drugs/pertuzumab/","drugState":"approved","record":"kristine","kind":"trial","label":"KRISTINE: phase 3, negative","href":"/trials/kristine/","quote":"Pathological complete response 44.4% (T-DM1 + pertuzumab) vs 55.7% (TCHP); more locoregional progression before surgery with T-DM1."},{"drugId":"relatlimab-nivolumab","drugName":"Relatlimab + nivolumab","drugRoute":"/drugs/relatlimab-nivolumab/","drugState":"approved","record":"relativity-098","kind":"trial","label":"RELATIVITY-098: phase 3, negative","href":"/trials/relativity-098/","quote":"RFS not improved."},{"drugId":"rituximab","drugName":"Rituximab","drugRoute":"/drugs/rituximab/","drugState":"approved","record":"calgb-50303","kind":"trial","label":"Alliance/CALGB 50303: phase 3, negative","href":"/trials/calgb-50303/","quote":"No difference in progression-free survival (hazard ratio 0.93) or overall survival (1.09) against R-CHOP, with substantially more febrile neutropenia, mucositis and neuropathy."},{"drugId":"rituximab","drugName":"Rituximab","drugRoute":"/drugs/rituximab/","drugState":"approved","record":"goya","kind":"trial","label":"GOYA: phase 3, negative","href":"/trials/goya/","quote":"Progression-free survival hazard ratio 0.92 (p = 0.39): no benefit over rituximab, with more grade 3 to 5 and fatal adverse events."},{"drugId":"sintilimab","drugName":"Sintilimab","drugRoute":"/drugs/sintilimab/","drugState":"approved","record":"sintilimab","kind":"regional","label":"FDA (US): rejected 2022","href":"/regulatory/regions/","quote":"CRL Mar 2022 for ORIENT-11 (single-country trial); ODAC 14 to 1"},{"drugId":"sintilimab","drugName":"Sintilimab","drugRoute":"/drugs/sintilimab/","drugState":"approved","record":"sintilimab","kind":"event","label":"US 2022-03: complete response letter","href":"https://web.archive.org/web/20250302091714/https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-10-2022-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02102022","quote":"Complete response letter for ORIENT-11 (first-line non-squamous NSCLC); ODAC voted 14 to 1 that additional data were needed for US applicability"},{"drugId":"trastuzumab","drugName":"Trastuzumab","drugRoute":"/drugs/trastuzumab/","drugState":"approved","record":"kristine","kind":"trial","label":"KRISTINE: phase 3, negative","href":"/trials/kristine/","quote":"Pathological complete response 44.4% (T-DM1 + pertuzumab) vs 55.7% (TCHP); more locoregional progression before surgery with T-DM1."}],"proposed":[],"note":"Every state is derived from the records named in evidence; untried means no medicine in this corpus combines the two parts. Proposed cells are hypotheses from the open pipeline (docs/OPEN-PIPELINE.md), not records of a medicine. CC BY-NC 4.0, attribute Data from OnCo (onco.cc). Not medical advice."}