Table 1.
Key dates in the development of rociletinib
| Date | Event |
|---|---|
| December 20, 2011 | Initiation of the clinical development program for rociletinib (CO-1686) with the TIGER-X trial |
| March 2012 | Start TIGER-X trial (NCT01526928): study to evaluate safety, pharmacokinetics, and efficacy of rociletinib (CO-1686) in previously treated mutant EGFR in NSCLC patients |
| May 14, 2013 | Orphan drug designation granted for rociletinib in EGFR mutation-positive NSCLC63 |
| April 2014 | Start TIGER-2 trial (NCT02147990): a Phase II, open-label, multicenter, safety and efficacy study of oral CO-1686 as second-line EGFR-directed TKI in patients with mutant EGFR NSCLC |
| May 19, 2014 | Breakthrough therapy designation granted by US FDA for treatment of patients with EGFR mutation-positive NSCLC with progression under prior EGFR-targeted therapy through T790M mutation63 |
| November 2014 | Start TIGER-1 trial (NCT02186301): safety and efficacy study of rociletinib (CO-1686) or erlotinib in patients with EGFR-mutant/metastatic NSCLC who have not had any previous EGFR-directed therapy |
| February 2015 | Start TIGER-3 trial (CT02322281): open label, multicenter study of rociletinib (CO-1686) monotherapy versus single-agent cytotoxic chemotherapy in patients with mutant EGFR NSCLC who have failed at least one previous EGFR-directed TKI and platinum-doublet chemotherapy |
| May 5, 2015 | Protocol amendment 2 submitted to change dose in TIGER-3 from 625 mg bid to 500 mg bid63 |
| June 9, 2015 | Preliminary report on efficacy Proposed dose for marketing: 500 mg bid63 |
| June 24, 2015 | Request for accelerated approval by US FDA64 |
| November 9, 2015 | Disagreement of US FDA with reported efficacy results due to the inclusion of unconfirmed responses64 |
| December 15, 2015 | Clovis states intention to change marketing dose to 625 mg bid Amendment to change dose to 625 mg bid for TIGER-3 trial |
| March 7, 2016 | Enrollment of TIGER-3 starts |
| March 8, 2016 | Amendment to add third study arm. Study now comprises 500 mg bid rociletinib, 625 mg bid rociletinib, and chemotherapy63 |
| May 6, 2016 | Announced stop of rociletinib development |
Abbreviations: NSCLC, non-small-cell lung cancer; EGFR, epidermal growth factor receptor; TKI, small molecule inhibitor; bid, twice a day; FDA, Food and Drug Administration.