TY - JOUR
T1 - KEYNOTE-032
T2 - A Randomized Phase I Study of Pembrolizumab in Chinese Patients with Advanced Non-Small Cell Lung Cancer
AU - Ma, Yuxiang
AU - Fang, Wenfeng
AU - Zhang, Yang
AU - Yang, Yunpeng
AU - Hong, Shaodong
AU - Zhao, Yuanyuan
AU - Xie, Shuang
AU - Ge, Jun
AU - Zhou, Hao Jin
AU - Zhao, Hongyun
AU - Zhang, Li
N1 - Publisher Copyright:
© AlphaMed Press; the data published online to support this summary are the property of the authors.
PY - 2020/8/1
Y1 - 2020/8/1
N2 - 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 curve0–21 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) μg•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.
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 curve0–21 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) μg•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.
UR - http://www.scopus.com/inward/record.url?scp=85081602645&partnerID=8YFLogxK
U2 - 10.1634/theoncologist.2020-0067
DO - 10.1634/theoncologist.2020-0067
M3 - Article
C2 - 32134163
AN - SCOPUS:85081602645
SN - 1083-7159
VL - 25
SP - 650-e1145
JO - Oncologist
JF - Oncologist
IS - 8
ER -
