Monday, January 12, 2015

Sanofi announces new Sarilumab monotherapy study

  • Sanofi aims to file its IL-6 mAb, Sarilumab in 2015 and has opened multiple Phase 3 studies to support this
  • MOBILITY, the key MTX-IR study first read out in 2013 with further data reported at EULAR 2014.  Of interest, analysis has reported that biomarkers of joint destruction were reduced within 2wks.  We understand that these biomarkers are being evaluated as possible prognostic tools to optimize the future use of Sarilumab although this requires validation
  • Sanofi has also announced two important safety studies. SARIL-RA-ONE is a new immunogenicity study; ASCERTAIN is comparing Sarilumab and (Ro)Actemra in TNF-IR patients
  • Sanofi‚Äôs focus is on TNF-IR patients and 2 further studies have been initiated: TARGET (vs placebo) and COMPARE (vs Enbrel). COMPARE is comparing Sarilumab and Enbrel in Humira-IR patients and is important to support use in this second line biologic space. Initially this study was expected to read out after the likely registration time-frame but Sanofi has now announced that it is no longer enrolling patients and we expect data to be included in the BLA
  • Now, Sanofi has announced SARIL-RA-MONARCH.  This 340 patient study aims to demonstrate Sarilumab superiority over Humira in a monotherapy (MTX-free) setting
  • The primary endpoint, DAS28 (ESR) at 12wks is expected to read out July 2016

Comments:  This study is similar to ADACTA, which was sponsored by Roche to occupy the MTX-unable space.  ADACTA demonstrated (Ro)Actemra superiority and has since been used to support one of Roche's key messages that MTX cannot be used in a substantial proportion of patients and that (Ro)Actemra offers an attractive first line biologic option in this situation.  We expect Sanofi to file Sarilumab around Q4 2015 suggesting approval late 2016.  If this turns out to be the case then data from SARIL-RA-MONARCH should be available to allow the filing of an sBLA soon after launch.  Data reported in Q4 2016 may prompt Sarilumab use as a monotherapy even prior to approval of an sBLA.  One criticism of ADACTA has been that Humira was dosed q2w despite labels indicating weekly dosing as an option in some patients.  In other words ADACTA was "designed for success".  It seems that SARIL-RA-MONARCH is likewise designed to dose Humira q2w  

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