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PD-1/PD-L1 임상개발 비교표
October, 2014
Clinical Trials for NSCLC (P3 Only)
Drug
Study Name
(Start/End)
# pts
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
Inclusion Criteria
*+Gemcitabine + cisplatin + carboplatin + paclitaxel + pemetrexed (investigators’ choice chemo)
** carboplatin + paclitaxel + pemetrexed
*** (pemetrexed + carboplatin) or (pemetrexed + cisplatin) or (gemcitabine + carboplatin) or (gemcitabine + cisplatin)
Arms
Design
Clinical Trials for Melanoma (P3/P2 Only)
Drug
Study Name
(Start/End)
# pts
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
Inclusion Criteria
• Advanced
* Dacarbazien or (carboplatin + paclitaxel)
** dabrafenib(BRAFT inhibitor) + trametinib(MEK inhibitor)
*** (carboplatin + paclitaxel) or paclitaxel or dacabazine or temozolomide
Arms Design
Active only
(Q2W or Q3W)