Tuesday, June 17, 2014

Takeda launches Entyvio (vedolizumab) in the US for IBD; Roche opens new Phase 3 etrolizumab study

  • Following May 20th approval by the FDA for UC and CD, Takeda has now launched Entyvio in the US [link]
  • Like Entyvio, Roche's etrolizumab blocks α4β7, but additional blockade of αEβ7 may produce further immunoregulation and greater efficacy
  • A Phase 3 UC program opened in April including a head to head vs infliximab in TNFi naïve patients and a placebo controlled study in experienced or intolerant patients [link]
  • Roche has now announced a further Phase 3 study, again in naives but comparing  etrolizumab to adalimumab
  • The 350 patient study is investigating induction, with the primary endpoint efficacy vs placebo.  Efficacy compared to adalimumab is a secondary endpoint.  Both endpoints are at 10wks, similar to the previously reported naive study
  • The study is expected to open Sept 2014, closing Sept 2017 potentially advancing filing as the previously reported studies are due to read out Q4 2018 and Q3 2019 (naives; vs infliximab)
This alert is from Pharma Information & Report's UpdatesPlus service

Comment:  Based on Roche's dates, we estimate a projected recruitment time of approximately 33mo.  This is longer than the 24mo taken to recruit GEMINI I which included more than double the number of patients (inc 689 TNFi naives).  It is unsure whether this duration is conservative and set to shorten; whether Roche believes recruitment will be slower with the added competition of Entyvio or whether it is simply investing less resources in expediting the study.  On a separate note, Roche has indicated Phase 3 CD studies will open but information has yet to be provided


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