Exelixis, Inc. (NASDAQ:EXEL) announced updated positive results for cobimetinib, an Exelixis-discovered investigational compound, in combination with vemurafenib for the treatment of patients with previously untreated BRAF V600 mutation-positive advanced melanoma. Updated data from coBRIM (Abstract #9006), the phase 3 pivotal trial conducted by Exelixis’ collaborator Genentech, a member of the Roche Group, showed the combination helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year (12.3 months) without disease progression or death, compared to 7.2 months with vemurafenib alone (hazard ratio [HR] = 0.58, 95% confidence interval [CI] 0.46-0.72). Data from a second trial, the phase 1b BRIM7 study (Abstract #9020), showed that treatment with the combination resulted in a median overall survival of more than two years (28.5 months) for patients without prior BRAF inhibitor treatment. Both data sets will be presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held this week in Chicago, Illinois.
“The updated results for the combination of cobimetinib and vemurafenib, including a median progression-free survival of one year in patients with previously untreated BRAF V600 mutation-positive advanced melanoma, are encouraging,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “The data underscore the potential for the combination to become a meaningful new treatment option for patients with this type of melanoma. We congratulate Genentech and Roche on two well-run trials, and we look forward to working with them to bring the combination to physicians and patients in the event of potential regulatory approval later this year.”
The updated results from coBRIM also showed higher response rates with cobimetinib and vemurafenib compared to vemurafenib alone. Objective response rate, a secondary endpoint of the trial, was 70% (16% compete response [CR], 54% partial response [PR]) with the combination compared to 50% (11% CR, 40% PR) with vemurafenib alone. The CR rate with the combination has increased from 10% to 16% with further follow-up as some patients who had an initial PR achieved a CR after more than one year of treatment. The safety profile of the combination was consistent with data previously reported. The most common adverse events in the combination arm include diarrhea, rash, nausea, fever, sun sensitivity, liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting.
Follow-up data from BRIM7, the phase 1b study that provided the rationale for the coBRIM pivotal trial, demonstrated that the combination of cobimetinib and vemurafenib resulted in a median overall survival of 28.5 months, with 61% of BRAF inhibitor-naive patients remaining alive after two years. The safety profile from the BRIM7 trial was consistent with previous analyses, and the incidence of serous retinopathy, cardiomyopathy and cutaneous squamous cell carcinoma were similar to those previously reported.
The coBRIM data will be presented in an oral session today by Dr. James Larkin, FRCP, of The Royal Marsden Hospital, London, UK (Abstract #9006, May 30, 3:15-3:27 pm CDT), while the BRIM7 data will be presented in a poster session by Dr. Anna Pavlick,New York University Medical Center (Abstract #9020, June 1, 1:15-4:45 pm CDT).
The cobimetinib New Drug Application for BRAF V600 mutation-positive advanced melanoma was granted priority review by the U.S. Food and Drug Administration (FDA) and a decision is expected by August 11, 2015. The European Medicines Agency is expected to make a decision on Roche’s marketing authorization application for cobimetinib before the end of this year. (Original Source)
Shares of Exelixis closed yesterday at $3.15, up $0.02 or 0.64%. EXEL has a 1-year high of $4.55 and a 1-year low of $1.26. The stock’s 50-day moving average is $3.13 and its 200-day moving average is $2.34.
On the ratings front, Cowen analyst Eric Schmidt reiterated a Hold rating on EXEL, in a report issued on February 26. According to TipRanks.com, Schmidt has a total average return of 66.7%, a 78.7% success rate, and is ranked #9 out of 3610 analysts.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.