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panda73金虫 (小有名气)
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FDA批准第一个抗PD1单抗-KEYTRUDA 已有8人参与
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2014年9月5日，Merck公司开发的抗PD1单抗(pembrolizumab，商品名. KEYTRUDA)获得FDA的加速批准，用于 ipilimumab和BRAF抑制剂治疗后进展的不可切除或转移的黑色素瘤治疗。批准的治疗剂量是2mg/kg/三周。 FDA的加速批准主要是基于 KEYNOTE-001 phase1b临床研究的结果。在推荐的剂量组（2mg/kg），总有效率为24%（21/89)，其中1个CR,20个PR。Merck将继续开展该单抗用于晚期黑色素瘤治疗的临床II期和III期的研究以提供确认性的证据。 Pembrolizumab(原名lambrolizumab)是一个人源化抗PD1单抗，可以阻断PD1与其两种配体PDL1和PDL2间的相互作用，进而激活人的免疫系统来杀灭肿瘤细胞。该单抗在临床中表现出来的主要副作用包括肺炎（2.9%），结肠炎（1%），肝炎，垂体炎，肾炎等。 |
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2楼2014-09-05 22:52:20
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3楼2014-09-06 13:55:15
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4楼2014-09-09 05:05:00
| 谢谢分享。 |
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7楼2014-09-09 10:09:12
wachina
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8楼2014-09-09 13:40:16
panda73
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The approval of KEYTRUDA was based on data from a multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease. Key eligibility criteria included prior treatment with ipilimumab (two or more doses at 3 mg/kg or higher) and a BRAF or MEK inhibitor, if BRAF V600 mutation positive; and disease progression within 24 weeks following the last dose of ipilimumab. Patients were randomized to receive 2 mg/kg (n=89) or 10 mg/kg (n=84) of KEYTRUDA every 3 weeks until unacceptable toxicity or disease progression. The major efficacy outcome measures were confirmed overall response rate as assessed by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and duration of response. Tumor response was assessed every 12 weeks. |
9楼2014-09-11 21:57:11
panda73
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KEYTRUDA is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States and received FDA’s Breakthrough Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need. For the recommended 2 mg/kg dose based on data in 89 patients, the overall response rate was 24 percent (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At the time of analysis, 86 percent (18/21) of patients with objective responses had ongoing responses with durations ranging from 1.4+ to 8.5+ months, including eight patients with ongoing responses of 6 months or longer. Fourteen percent (3/21) had progression of disease 2.8, 2.9, and 8.2 months after initial response. |
10楼2014-09-11 21:58:27
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