Phase III study of first-line monotherapy
(KEYNOTE-024 and CheckMate 026)
1. Reck, et al. N Engl J Med 2016; 2. Reck, et al. ESMO 2016; 3. Socinski, et al. ESMO 2016
•
Stage IV NSCLC (
EGFR
WT,
ALK
-)
•
Squamous or non-squamous
•
PD-L1 ≥50% by IHC
•
No prior chemotherapy
•
ECOG PS 0–1
(n=305)
Paclitaxel or pemetrexed or
gemcitabine + carboplatin or cisplatin
(4–6 cycles)
1
2
PFS
OS, ORR, PFS in patients with any PD-L1 status
Endpoints
Pembrolizumab 200mg i.v. q3w (max.
35 cycles)
Optional pemetrexed
maintenance
•
PD-L1 TPS
≥50%
by IHC
Until PD
Crossover to pembrolizumab permitted
R
1
2
OS, ORR, PFS
Endpoints
PFS in patients with
PFS in ITT population (PD-L1 TC ≥1% by IHC) [co-primary]
•
PD-L1
TC ≥5%
by IHC [co-primary]
•
Stage IV or recurrent NSCLC
•
No prior systemic therapy
•
PD-L1 TC ≥1% by IHC
•
ECOG PS 0–1
(n=541)
Investigator’s choice chemotherapy
(Gemcitabine + cisplatin or carboplatin, paclitaxel + carboplatin,
or pemetrexed + cisplatin or carboplatin)
Nivolumab 3mg/kg i.v. q2w
Until PD
Crossover to nivolumab permitted
R
KEYNOTE-024
1,2
CheckMate 026
3
•
PD-L1 TC
≥1%
by IHC
