Clovis Oncology begins tiger2 study for the treatment of NSCLC patients with EGFR mutations / T70M of

Clovis Oncology begins tiger2 study for the treatment of NSCLC patients with EGFR mutations / T70M of -

Clovis Oncology, Inc. (NASDAQ: CLVS) announced today the study began with tiger2 dosing of the first patient in a US study site. CO-1686 is again of the company, targeted covalent oral (irreversible) inhibitor of mutant forms of the receptor for epidermal growth factor (EGFR) for the treatment of cancer non-small cell lung cancer (NSCLC) in patients with mutations initial activation of EGFR and as the dominant mutation T70M resistance.

"In the clinic, we see a need for more and more acute for effective treatments against T70M" said Lecia V. Sequist, MD, MPH, Massachusetts General Hospital Cancer Center and associate professor of medicine at Harvard Medical School and principal investigator of the study phase 1/2 CO-1686. "CO-1686 provides a path of hope for patients who otherwise may use the old standard of chemotherapy is often ineffective and comes with many other side effects."

"We are pleased to begin tiger2 enlist, our registration study for CO-1686 focused on the T70M positive patients who have progressed after first EGFR targeted therapy," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "The CO-1686 data observed to date have been very consistent, including the growing evidence of a long-term benefit and tolerability profile of the drug. We remain committed to file an NDA in mid-2015 on the based on this study and TIGERX during the expansion cohorts. "

data recently presented at the 2014 American Society of Clinical oncology annual meeting included the activity and results of safety in 40 evaluable centrally confirmed positive patients T70M through effective doses in the expansion phase 1 dose of study and the early expansion phase 2 cohorts. These include 23 partial responses (PR) observed in early May, for an objective response rate of 58 percent (ORR). Thirty-six of 40 evaluable T70M positive patients, or 0 percent, experienced stable disease or a PR. nervous system (CNS) Central Responses have also been observed in heavily pretreated patients positive T70M. The median duration of response can not yet be determined positive patients T70M. Similarly, the median PFS was not reached. However, monitoring of some patients over one year, and the current estimate for the median PFS than 12 months. CO-1686 is well tolerated, with no signs of systemic inhibition of EGFR wild-type. In the Phase 1 study, the most common adverse events were nausea, hyperglycemia, diarrhea, vomiting and decreased appetite, and these were mostly grade 1 or 2 in severity . The most common grade 3 adverse events were hyperglycemia, which was observed in 22 percent of patients. Hyperglycaemia when viewed in need of treatment, is generally managed by a single agent orally commonly prescribed.

breakthrough therapy designation was granted by the FDA last month for CO-1686 as monotherapy for the treatment of EGFR-mutant NSCLC patients with T70M mutation after progression on EGFR-directed therapy.

tiger2 the study is the first of three recording studios in the (third-generation inhibitor of mutant EGFR in lung cancer) TIGER program scheduled to launch in 2014. Tiger2 The study is conducted in T70M positive patients directly after the progression of their first and only TKI therapy. Study sites are now part of the United States, Europe and Australia. For more information about the study, please visit www.tigertrials.com.

The tiger2 study is recruiting 125 patients with NSCLC EGFR T70M mutation mutant with centrally confirmed that CO-1686 to receive recommended phase 2 dose (RP2D) of 625mg BID. The primary endpoint of the study is the overall response rate; Secondary endpoints include duration of response, progression-free survival, overall survival and safety.

In addition to tiger2, Clovis recruits currently two Phase 2 expansion cohort of a Phase 1/2 EGFR mutant patients with T70M mutation; the first comprises about 150 to 0 T70M positive patients directly after the progression of their first and only TKI therapy, comparable to the population at tiger2 recording studio. The second cohort includes about 150 to 0 line later T70M positive patients after progression of their second or later TKI therapy or subsequent chemotherapy. Both cohorts exploring 500mg doses of 625mg and 750mg bid.

The data expansion cohort, combined with tiger2 data, should be the basis of an NDA submission for CO-1686 to mid-2015.

Clovis plans to launch the part of Phase 2 of TIGER1 study, a randomized phase 2/3 study study CO-1686 registration compared to erlotinib in EGFR mutant patients newly diagnosed in mid-2014. TIGER3 The study, a randomized, comparative study versus chemotherapy in patients positive T70M directly after the progression of their first and only TKI therapy, expected to open in the second half of 2014.

The Company launched its phase 1 study CO-1686 in Japan during the first quarter of 2014.