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Exelixis Announces Second Quarter and Year to Date 2016 Financial Results and Provides Corporate Update

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the second quarter of 2016 and provided an update on progress toward delivering upon its key 2016 corporate objectives, as well as commercial and clinical development milestones.

“The Exelixis team has worked tirelessly to prepare for and execute on the U.S. launch of CABOMETYX in order to bring this important new therapeutic option for advanced kidney cancer to prescribing clinicians and the patients they serve”

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Exelixis is focused on executing the U.S. launch of CABOMETYX™ (cabozantinib) tablets as a treatment for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The first prescriptions for CABOMETYX were filled within three days of approval by the U.S. FDA on April 25. CABOMETYX generated $17.6 million in net product revenue during the remaining nine weeks of the second quarter of 2016. Net product revenues for the second quarter of 2016, including sales of COMETRIQ® (cabozantinib) capsules, were $31.6 million.

“The Exelixis team has worked tirelessly to prepare for and execute on the U.S. launch of CABOMETYX in order to bring this important new therapeutic option for advanced kidney cancer to prescribing clinicians and the patients they serve,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We are encouraged by the initial uptake in May and June and are steadfast in our efforts to support the launch by educating the treatment community on the data in the CABOMETYX label, which differentiate this medicine from others available for patients with previously-treated advanced renal cell carcinoma.”

Cabozantinib Highlights

CABOMETYX Approved by U.S. FDA. On April 25, 2016, the U.S. FDA approved CABOMETYX for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. CABOMETYX is the first therapy to demonstrate robust and clinically meaningful improvements in all three key efficacy parameters - overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) - in a phase 3 trial (METEOR) of patients with advanced RCC. Approximately 17,000 patients with advanced RCC in the U.S. and 37,000 globally require second-line or later treatment.1

Positive Top-Line Results from CABOSUN Randomized Phase 2 Trial. On May 23, 2016, Exelixis announced that CABOSUN, the independent randomized phase 2 trial of cabozantinib in patients with previously untreated advanced RCC, met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with advanced intermediate- or poor-risk RCC. CABOSUN is being conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP). Presentation of the CABOSUN results is planned for an upcoming medical meeting. Exelixis is discussing the results with regulatory authorities and evaluating potential next steps in the development and submission strategy for cabozantinib as a first-line treatment for patients with advanced RCC.

European CHMP Adopts Positive Opinion for Cabozantinib for the Treatment of Advanced RCC. On July 22, 2016, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of the Marketing Authorization Application (MAA) for cabozantinib for the treatment of adult patients with advanced RCC who have received at least one prior VEGF receptor tyrosine kinase inhibitor therapy. The CHMP's positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Exelixis and Ipsen, its partner for the development and commercialization of cabozantinib outside of the United States, Canada and Japan, anticipate a decision from the EC before the end of this year.

CELESTIAL Second-line Hepatocellular Carcinoma (HCC) Data Anticipated in 2017. Enrollment continues for CELESTIAL, the phase 3 pivotal trial comparing cabozantinib to placebo in patients with advanced HCC who have previously been treated with sorafenib. Initiated in September 2013, the trial is designed to enroll 760 patients at approximately 200 sites. Patients are being randomized 2:1 to receive 60 mg of cabozantinib daily or placebo. The primary endpoint for CELESTIAL is OS, and the secondary endpoints include PFS and ORR. Exelixis anticipates results from this trial in 2017. New treatment options are needed for HCC patients who progress following sorafenib, the current standard of care.

Other Cabozantinib Development Program Updates. While Exelixis pursues cabozantinib’s late-stage development in advanced RCC and advanced HCC, earlier-stage investigation of the compound continues through the company’s collaboration with the NCI-CTEP, and its ongoing Investigator-Sponsored Trial (IST) program. Through these two programs, there are more than 45 ongoing or planned studies including trials in advanced RCC, bladder cancer, colorectal cancer (CRC), non-small cell lung cancer, and endometrial cancer. Data from several studies, including CABOSUN and a phase 1b study evaluating the combination of cabozantinib with nivolumab or nivolumab and ipilimumab, are expected to be presented in the second half of 2016.

Cobimetinib Highlights

Initiation of COTEZO Phase 3 Pivotal Trial in Advanced CRC. In June 2016, Exelixis’ partner Genentech (a member of the Roche Group) announced the initiation of COTEZO, the phase 3 pivotal trial of the combination of cobimetinib, the Exelixis-discovered MEK inhibitor, and atezolizumab, an anti-PD-L1 antibody, in unresectable locally advanced or metastatic CRC. COTEZO is designed to enroll 360 patients who have received at least two prior chemotherapies in the metastatic disease setting, and the primary endpoint of the trial is OS. The decision to start COTEZO was informed by results from the ongoing phase 1b trial of the combination in advanced solid tumors, and results from CRC patients enrolled in this trial were presented during an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2016.

Additional Regulatory Approvals for COTELLIC®. In April and May 2016, Australia’s Therapeutic Goods Administration and Brazil’s ANVISA, respectively, approved COTELLIC for use in combination with Zelboraf for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Corporate Highlights

Cabozantinib, Cobimetinib and XL888 Data Presentations at ASCO 2016. Exelixis-discovered compounds were the subject of 18 presentations at the meeting, including an...