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NSCLC: Update Bulletin [April 2016]

Product Code:
Publication Date:
April 2016

Gain new KOL insights on the latest events with the potential to shape the targeted treatment of Non-Small Cell Lung Cancer (NSCLC). Topics covered include opinions about the FDA advisory committee vote against approval of Clovis’s EGFR inhibitor rociletinib, the US FDA priority review granted for Roche’s PD-L1 inhibitor atezolizumab for the treatment of locally advanced or metastatic NSCLC expressing PD-L1, the EMA’s CHMP recommendation for approval of BMS’s Opdivo (nivolumab) for the treatment of locally advanced or metastatic NSCLC after prior chemotherapy, OSE Pharma’s Phase III trial of its OSE 2101 vaccine for the second- or third-line treatment of advanced HLA-A2 positive NSCLC, the US FDA and EU approval Boehringer Ingelheim's afatinib (Gilotrif /Giotrif) for the treatment of advanced squamous NSCLC that has progressed on or after platinum-based chemotherapy, and Ariad’s initiation of Phase III development of its ALK inhibitor brigatinib.

  • What factors were primarily responsible for the negative FDA review for Clovis’s rociletinib, and what lessons can be learned?
  • How do KOLs view the likely outcome of the TIGER-3 trial of Clovis’ rociletinib?
  • Assuming Clovis’ rociletinib finally gains approval, how successful will it be in competing with Tagrisso (osimertinib; AstraZeneca)?
  • How do KOLs view Roche’s anti- PD-L1 monoclonal antibody, atezolizumab, compared with BMS’ Opdivo (nivolumab) and Merck & Co.’s Keytruda (pembrolizumab)?
  • How do KOLs rate PD-L1 as a biomarker to guide the treatment of NSCLC with Roche’s atezolizumab?
  • How do KOLs interpret the recent broadening of Opdivo’s indication in the EU?
  • How will the widening of the US and EU indication for Giotrif/Gilotrif (afatanib; Boehringer Ingelheim) impact its use?
  • What expectations do KOLs hold for OSE Pharma’s OSE 2101 as a potential NSCLC treatment?
  • How do KOLs rate Ariad’s brigatinib as a potential treatment for ALK-positive NSCLC?


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