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PD-1/PD-L1 임상개발 비교표. October, 2014. Clinical Trials for NSCLC (P3 Only). *+Gemcitabine + cisplatin + carboplatin + paclitaxel + pemetrexed (investigators’ choice chemo) ** carboplatin + paclitaxel + pemetrexed - PowerPoint PPT Presentation
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PD-1/PD-L1 임상개발 비교표
October, 2014
Clinical Trials for NSCLC (P3 Only)Drug Study Name
(Start/End) # pts Inclusion 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
MPDL3280
(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)
Clinical Trials for Melanoma (P3/P2 Only)Drug Study Name
(Start/End) # pts Inclusion Criteria Arms 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 chemotherapyActive vs. dacarbazine
Optivo(P3)
CheckMate 067(May2013/Oct2017) 915 • Stage III or IV
• Treatment naïve patientOpdivo 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