#PD-L1
Roche今天宣布
旗下PD-L1抑制剂上市申请
Tecentriq组合方案
获得FDA授予的优先审评资格
该申请为Tecentriq联合白蛋白紫杉醇
用于一线治疗PD-L1+转移性三阴性乳腺癌
PDUFA为2019年3月12日
如果获批
这将是首个应用于TNBC的免疫治疗方案
Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat. We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive metastatic triple-negative breast cancer as soon as possible.
——Sandra Horning, MD.
Roche’s Chief Medical Officer and Head of Global Product Development
该上市申请基于临床研究
IMpassion130（NCT02425891）
该临床首次公布于2015年4月
招募共计902名受试者
均未接受过化疗或靶向全身治疗
试验组为Tecenriq+白蛋白紫杉醇
对照组为安慰剂+白蛋白紫杉醇
中位随访时间12.9个月
ITT分析结果
ORR=56.0% vs. 45.9%
mPFS=7.2个月 vs. 5.5个月
HR=0.80 (95% CI, 0.69–0.92)
P=0.0025
mOS=21.3个月 vs. 17.6个月
HR=0.84 (95% CI, 0.69–1.02)
P=0.08
PD-L1阳性分析结果
ORR=58.9% vs. 42.6%
mPFS=7.5个月 vs. 5.0个月
HR=0.62 (95% CI, 0.49–0.78)
P<0.001
mOS=25.0个月 vs. 15.5个月
HR=0.62 (95% CI, 0.45–0.86)
（由于分层设计原因，mOS数据为Kaplan–Meier分析）
“如果能重来
试验设计方案将会是不同的”
最终获得优先审评的上市申请
还是针对PD-L1阳性患者
即PD-L1≥1%
不过对于TNBC来说
该免疫组合疗法方案的上市
也已经是很大的进步了
附PD-(L)1三阴性乳腺癌临床
