PMID- 32134163
OWN - NLM
STAT- MEDLINE
DCOM- 20210618
LR  - 20210618
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 25
IP  - 8
DP  - 2020 Aug
TI  - KEYNOTE-032: A Randomized Phase I Study of Pembrolizumab in Chinese Patients with 
      Advanced Non-Small Cell Lung Cancer.
PG  - 650-e1145
LID - 10.1634/theoncologist.2020-0067 [doi]
AB  - LESSONS LEARNED: Results of the KEYNOTE-032 study showed that the safety and 
      pharmacokinetic profiles of pembrolizumab in Chinese patients were comparable 
      with those observed in international studies, and antitumor activity was 
      encouraging. These data support further evaluation of pembrolizumab to improve 
      clinical outcomes in Chinese patients with advanced non-small cell lung cancer. 
      BACKGROUND: The KEYNOTE-032 study evaluated pembrolizumab pharmacokinetics and 
      clinical outcomes in Chinese patients with locally advanced and/or metastatic 
      non-small cell lung cancer (NSCLC) and prior treatment failure and/or 
      ineligibility for standard therapy. METHODS: Patients were randomized 1:1:1 to 
      pembrolizumab 2 mg/kg, 10 mg/kg, or 200 mg every 3 weeks (up to 35 cycles). 
      Safety and pharmacokinetics were primary endpoints; antitumor activity was a 
      secondary endpoint. RESULTS: A total of 42 of 44 randomized patients received 
      pembrolizumab treatment (2 mg/kg, n = 14; 10 mg/kg, n = 13; 200 mg, n = 15). 
      Treatment-related adverse events (AEs) occurred in 29 of 42 (69%) patients (grade 
      3-4, 4/42 [10%]); 5 (12%) had immune-mediated AEs and infusion reactions. 
      Pembrolizumab single dose half-life following 2 mg/kg, 10 mg/kg, and 200 mg was 
      15.1, 15.8, and 12.3 days, respectively. Serum exposure at the doses studied 
      (range, 2-10 mg/kg) was approximately linear; steady-state area under the 
      curve(0-21 days) (95% confidence interval [CI]) was 730.9 (627.4-851.6), 2,819.2 
      (2,009.4-3,955.4), and 931.0 (724.4-1,196.6) mug*day/mL, respectively. After 7.9 
      (range, 0.7-13.1) months median follow-up overall, objective response rate was 
      14.3% (95% CI, 5.4%-28.5%); median progression-free survival was 2.1 (95% CI, 
      2.1-4.2) months, and median overall survival was not reached (95% CI, 6.6 
      months-not reached). CONCLUSION: Pembrolizumab had manageable toxicity, linear 
      serum exposure, and encouraging antitumor activity in Chinese patients with 
      advanced NSCLC.
CI  - (c) AlphaMed Press; the data published online to support this summary are the 
      property of the authors.
FAU - Ma, Yuxiang
AU  - Ma Y
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's 
      Republic of China.
FAU - Fang, Wenfeng
AU  - Fang W
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's 
      Republic of China.
FAU - Zhang, Yang
AU  - Zhang Y
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's 
      Republic of China.
FAU - Yang, Yunpeng
AU  - Yang Y
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's 
      Republic of China.
FAU - Hong, Shaodong
AU  - Hong S
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's 
      Republic of China.
FAU - Zhao, Yuanyuan
AU  - Zhao Y
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's 
      Republic of China.
FAU - Xie, Shuang
AU  - Xie S
AD  - MSD China, Beijing, People's Republic of China.
FAU - Ge, Jun
AU  - Ge J
AD  - MSD China, Shanghai, People's Republic of China.
FAU - Zhou, HaoJin
AU  - Zhou H
AD  - MSD China, Beijing, People's Republic of China.
FAU - Zhao, Hongyun
AU  - Zhao H
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's 
      Republic of China.
FAU - Zhang, Li
AU  - Zhang L
AD  - Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South 
      China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's 
      Republic of China.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200305
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - DPT0O3T46P (pembrolizumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy
MH  - China
MH  - Humans
MH  - *Lung Neoplasms/drug therapy
PMC - PMC7418348
EDAT- 2020/03/07 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/08/01
CRDT- 2020/03/06 06:00
PHST- 2020/01/13 00:00 [received]
PHST- 2020/01/24 00:00 [accepted]
PHST- 2020/03/07 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/03/06 06:00 [entrez]
PHST- 2020/08/01 00:00 [pmc-release]
AID - ONCO13261 [pii]
AID - 10.1634/theoncologist.2020-0067 [doi]
PST - ppublish
SO  - Oncologist. 2020 Aug;25(8):650-e1145. doi: 10.1634/theoncologist.2020-0067. Epub 
      2020 Mar 5.