Encouraging Selumetinib Results Announced for Phase 2 Trial in Ovarian Cancer
BOULDER, Colo.--(BUSINESS WIRE)--Apr 4, 2012 - The Gynecologic Oncology Group presented results of a Phase 2 trial with selumetinib, a small-molecule MEK inhibitor, in women with recurrent low-grade serous ovarian or peritoneal cancer at the American Association for Cancer Research Annual Meeting 2012 on Monday, April 2, 2012. Selumetinib was invented by Array BioPharma Inc. (NASDAQ: ARRY) and licensed to AstraZeneca. This trial was funded by the National Cancer Institute and run by the Gynecologic Oncology Group.
In the reported trial, 52 women each received 100-mg doses of selumetinib orally twice daily in four-week cycles until disease progression or toxicity. The median number of cycles received was 4.5; 33% underwent 12 or more cycles. Prior to the trial, 58% of the patients in the trial had received three or more rounds of chemotherapy.
The Gynecological Oncology Group reported a disease control rate, defined as either complete or partial response or progression-free survival or progression-free survival of greater than 6 months, of 81% of patients. Eight patients had complete (1) or partial (7) responses, and 34 (63%) had progression-free survival of greater than 6 months. The median survival rate without cancer progression was 11 months. Only three patients experienced grade 4 adverse events.
Selumetinib is an anti-cancer drug in Phase 2 development in a range of tumors, including BRAF-mutant melanoma and KRAS-mutant non-small cell lung cancer. It is a small-molecule MEK inhibitor that regulates a key protein in the Ras-Raf-MEK-ERK signaling pathway. This pathway has been shown to be frequently activated in cancer, in particular in tumors that have RAS and RAF mutations.
Array anticipates top-line results for the Phase 2 trial with selumetinib in combination with dacarbazine versus dacarbazine alone as first-line treatment in patients with BRAF-mutant melanoma to be reported in 2012. This trial, sponsored by AstraZeneca, completed enrollment of 91 patients in March 2010 and has the primary endpoint of overall survival.
In addition, Array expects that further data and analyses will be presented in the second quarter of 2012 for the randomized Phase 2 trial conducted by AstraZeneca comparing selumetinib in combination with docetaxel versus docetaxel alone in the second-line treatment of patients prospectively selected with KRAS-mutant, locally advanced or metastatic, non-small cell lung cancer. Array previously announced positive top-line results from this trial including statistically significant improvement in progression-free survival, objective response rate, and alive and progression-free at six months as well as numerical improvement in overall survival.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Array has four core proprietary clinical programs: ARRY-614 for myelodysplastic syndromes, ARRY-520 for multiple myeloma, ARRY-797 for pain and ARRY-502 for asthma. In addition, Array has 10 partner-funded clinical programs including two MEK inhibitors in Phase 2: selumetinib with AstraZeneca and MEK162 with Novartis. For more information on Array, please go to www.arraybiopharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the timing of completion or initiation of further trials involving selumetinib, the timing of the announcement of the results of clinical trials involving selumetinib, the potential for the results of ongoing clinical trials to support regulatory approval or the marketing success of selumetinib, and AstraZeneca's future plans to progress and develop selumetinib. These statements involve significant risks and uncertainties, including those discussed in the most recent annual report filed on Form 10-K, quarterly reports filed on Form 10-Q, and other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect current expectations concerning future events, actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, the ability of AstraZeneca to continue to fund and successfully progress research and development efforts with respect to selumetinib; risks associated with dependence on collaborators for the clinical development and commercialization of out-licensed drug candidates, including selumetinib; the ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; and risks associated with dependence on third-party service providers to successfully conduct clinical trials within and outside the United States. Array is providing this information as of April 4, 2012 and undertakes no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.
Contact: Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
Posted: April 2012