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