罗氏撤回向EMA提交的Atezo+Beva上市申请

链接：https://www.ema.europa.eu/documents/withdrawal-letter/withdrawal-letter-tecentriq_en.pdf

中心思想：Roche withdraws EMA application for Tecentriq + Avastin combo in 1L RCC whose PD-L1≥1%

理由是 IMmotion151 data "not sufficient to support an extension of indication"

尽管撤回，但是仍然会continue to next analysis of overall survival

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回看IMmotion151，PFS in PD-L1≥1% 的HR 0.74，PFS ITT HR 0.83

ESMO上那个JAVELIN Renal 101，不知道比这个结果高到哪里去了，我和他是谈笑风生（正文无此句）

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那么这口锅sei来背呢

Roche withdraws Tecentriq and Avastin RCC submission

Admitting that its trial results are not strong enough, Roche (ROG: SIX) has told the European Medicines Agency (EMA) not to consider a type II variation to extend the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab).

The Swiss pharma giant had been seeking a label extension for the combination of its two drugs to treat unresectable locally-advanced or metastatic renal cell carcinoma (RCC) patients whose tumors have a PD-L1 expression of at least 1%.

Tecentriq, a PD-L1 inhibitor, has been approved in a couple of cancer indications and Roche has been keen to prove its worth alongside the anti-VEGF drug Avastin, but results from the IMmotion151 trial are not strong enough to support the RCC application at present, the company has decided.

The trial had met its co-primary endpoint of investigator-assessed progression-free survival in people whose disease expressed the PD-L1 protein, though Roche now wants to add overall survival data before proceeding.

Roche has stressed that the withdrawal does not have any impact on ongoing trials with Tecentriq either as a monotherapy or in combination with other agents.