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PD-1/PD-L1 임상개발 비교표 October, 2014. Clinical Trials for NSCLC (P3 Only) Drug Study Name (Start/End) # ptsInclusion Criteria Arms Design Optivo CheckMate.

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Presentation on theme: "PD-1/PD-L1 임상개발 비교표 October, 2014. Clinical Trials for NSCLC (P3 Only) Drug Study Name (Start/End) # ptsInclusion Criteria Arms Design Optivo CheckMate."— Presentation transcript:

1 PD-1/PD-L1 임상개발 비교표 October, 2014

2 Clinical Trials for NSCLC (P3 Only) Drug Study Name (Start/End) # ptsInclusion Criteria Arms Design Optivo CheckMate 017 (Jun2012/Jan2017) 264 Locally advanced or metastatic (Stage IIIB or IV or recurrent) squamous Recurred or progressed during/after one prior Pt doublet chemo Active vs. Docetaxel Optivo CheckMate 057 (Nov2012/May2016) 582 Locally advanced or metastatic (Stage IIIB or IV or recurrent) non-squamous Recurred or progressed during/after one prior Pt doublet chemo Active vs. Docetaxel Optivo CheckMate 026 (Jul2013/Jan2018) 495 Stage IV or recurrent PD-L1+ No prior systemic anticancer therapy Active vs combo(*) Optivo CheckMate 153 (Feb2014/Mar2019) 780 Stage IIIB or IV or recurrent Prior at least one systemic therapy Standalone Keytruda KEYNOTE-042 (Oct 2014/Jul2019) 1,200 PD-L1 positive advanced or metastatic No prior systemic chemotherapy Active vs. SOC(**) Keytruda KEYNOTE-024 (Aug2014/May2018) 300 PD-L1 positive, EGFR(+), EML4/ALK fusion(-), strong metastatic (stage IV) No prior systemic chemo Active vs. 4 SOCs(***) Keytruda KEYNOTE-010 (Aug2013/Jan2020) 920 PD-L1 positive Radiographic progression after treatment with at least 2 cycles of pt doublet Active vs. Docetaxel MEDI4736 PACIFIC (May2014/Jan2020) 702 Locally advanced, unresectable (Stage III) Not progressed after at least 2 cycle of Pt chemo Active vs. Placebo MPDL328 0 (RG7446) OAK (Mar2014/ Jun2017) 850 Locally advanced or metastatic (Stage IIIB or IV or recurrent) Progressed during/following Pt chemo or Recurred within 6 months after Pt chemo Active vs. Docetaxel *+Gemcitabine + cisplatin + carboplatin + paclitaxel + pemetrexed (investigators’ choice chemo) ** carboplatin + paclitaxel + pemetrexed *** (pemetrexed + carboplatin) or (pemetrexed + cisplatin) or (gemcitabine + carboplatin) or (gemcitabine + cisplatin)

3 Clinical Trials for Melanoma (P3/P2 Only) Drug Study Name (Start/End) # ptsInclusion CriteriaArms Design Optivo (P3) CheckMate 037 (Dec2012/Jan2016) 390 Stage III or IV Progressing post anti-CTLA-4 therapy Active vs. SOC(*) Optivo (P3) CheckMate 066 (Jan2013/Jan2016) 410 Stage III or IV without BRAF mutation No prior chemotherapy Active vs. dacarbazine Optivo (P3) CheckMate 067 (May2013/Oct2017) 915 Stage III or IV Treatment naïve patient Opdivo vs. (Opdivo+ Yervoy) Optivo (P3) Unnaned (Nov2014/Apr2016) 300 Metastatic or unresectable and clearly progressive BRAFTV600E or BRAFV600K mutant positive (Opdivo + Yervoy) vs chemo(**) Optivo (P2) CheckMate 069 (Aug2013/Apr2015) 150 Stage III or IV No prior systemic anticancer therapy (Opdivo + Yervoy) vs Yervoy Keytruda (P3) KEYNOTE-006 (Aug2013/Mar2016) 645 Stage III or metastatic First-line or second-line Active vs. Yervoy Keytruda (P2) KEYNOTE-002 (Nov2012/Jan2016) 510 Stage III or metastatic Ipilimumab refractory If BRAF mutant, prior treatment with BRAF or MEK protein inhibitor Active (L & H) vs. SOC(***) MEDI4736 (P2) Unnamed (Aug2012/Mar2016) 69 Advanced Active only (Q2W or Q3W) * Dacarbazien or (carboplatin + paclitaxel) ** dabrafenib(BRAFT inhibitor) + trametinib(MEK inhibitor) *** (carboplatin + paclitaxel) or paclitaxel or dacabazine or temozolomide


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