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看了下施贵宝和默沙东，膀胱癌和霍奇金淋巴瘤用单臂试验就能上市，但是试验例数一般在200以上，百济的膀胱癌只有110人，霍奇金淋巴瘤68人，人数太少，如果后续增加人数，还真可能直接上市，另外君实生物的膀胱癌有200人，也是强劲对手。
果然。。
Beigene’s goal here is to use a Phase II trial to push through the first PD-1 checkpoint approval in China, which has seen a groundswell of R&D at a growing slate of biotech upstarts. Their primary goal is the overall response rate, with secondaries on progression-free survival, duration of response, complete response rate, time to response, safety, and tolerability under the guidance of lead investigator Professor Jun Zhu of the Peking University Cancer Hospital.
110是有点少啊。不过百济官方说法是“pivotal study”所以数据应该是要用来注册的。可能正如你说的后期要持续加人。
后期加人也常见，BMS的checkmate277去年下半年还决定直接加了一个Opdivo+化疗的组。