2017WCLC免疫治疗进展

•
Satouchi, et al. WCLC 2017
•
8
•POPLAR: a randomized Phase II 源自文库tudy of atezolizumab vs docetaxel in 2L/3L NSCLC (POPLAR)
• Atezolizumab (anti–PD-L1) has demonstrated OS benefit over docetaxel (HR, 0.73 [95% CI: 0.53, 0.99]) in a randomized Phase II study, POPLAR, in patients with advanced NSCLC1This benefit has been confirmed in the randomized Phase III study OAK2
Locally advanced or metastatic NSCLC
• 1–2 prior lines of chemotherapy including at least 1 platinum-based therapy
• Any PD-L1 status
Atezolizumab 1200 mg IV q3w
IImmunotherapy in Non-Small Cell Lung Cancer 2O17 WCLC
Brake and accelerator of immune reaction
CD28 starter/accelerator CTLA4 parking brake
Parking
ICOS accelerator PD-1 brake
•
LTS, long-term survivors.
•
a 27 atezolizumab- and 49 docetaxel-arm patients were censored prior to 24 months and excluded from this analysis.
•
Data cutoff: 23 January, 2017.
(n = 222)
• TC3 or IC3 = TC ≥ 50% or IC ≥ 10% PD-L1+; TC2/3 or IC2/3 = TC or IC ≥ 5% PD-L1+; TC1/2/3 or IC1/2/3 = TC or IC ≥ 1% PD-L1+; TC0 and IC0 = TC and IC < 1% PD-L1+.
•
Satouchi, et al. WCLC 2017
•
7
•Long-term survival benefit by histology and PD-L1 expression subgroups
2-year OS Rate (%)
40
40
35%
31%
30
30
24%
21%
20%
20
20
43%
Atezolizumab
R 1:1
Stratification Factors
• PD-L1 IC expression (0 vs 1 vs 2 vs 3)a • Histology (squamous vs non-squamous) • Prior chemotherapy regimens (1 vs 2)
Non-LTSa
(Non‒long-term survivors) Patients that died within 24 months of randomization
•
6
•Landmark 2-year overall survival in OAK
Overall survival (OS) in ITT850
Driving
3
肺癌治疗：从细胞毒药物化疗时代跨入免疫治疗时代
Dragani et al. BMC Medicine (2016) 14:110
免疫治疗与标准二线化疗比较
•OAK: Phase III study of atezolizumab vs docetaxel in 2L/3L NSCLC
Metastatic or locally advanced NSCLC (2L/3L)
Disease progression on a prior platinum therapy
N = 287
Atezolizumab
1200 mg IV q3w until loss of clinical benefit
PD or loss of clinical benefit
R
No crossover to
1:1
atezolizumab allowed
Docetaxel 75 mg/m2 IV q3w
PD
Survival follow-up
• Primary endpoint (first 850 enrolled patients): OS in the ITT population (ITT850) • Data cutoff: 23 January, 2017; Minimum follow-up: 26 months
40
Docetaxel
35%
32% 30%
30
23%
24%
20
17%
18%
12%
10
10
10
0
0
0
ITT
Non-squamous Squamous
TC3 or IC3 TC2/3 or IC2/3 TC1/2/3 or TC0 and IC0
(n = 425)
(n = 313)
(n = 112)
(n = 72)
• a Patients censored prior to 24 months were excluded from this analysis. • NCT02008227.
•
Satouchi, et al. WCLC 2017
LTS
(Long-term survivors) Patients who lived ≥ 24 months since randomization
(n = 129)
IC1/2/3
(n = 180)
(n = 425)
(n = 315)
(n = 110)
(n = 65)
(n = 136)
(n = 241)
(n = 199)
• IC, tumor-infiltrating immune cells; TC, tumor cells. Data cutoff: 23 January, 2017.