ALAMEDA - Exelixis, Inc. (Nasdaq: EXEL) today announced positive results from IMspire150, the phase 3 trial of atezolizumab (TECENTRIQ), cobimetinib (COTELLIC) and vemurafenib (ZELBORAF) in people with previously untreated BRAF V600 mutation-positive advanced melanoma.
Genentech, Inc. (a member of the Roche Group), Exelixis' collaborator and the sponsor of the IMspire150 trial, informed the company that the study met its primary endpoint of progression-free survival (PFS). Adding atezolizumab to cobimetinib and vemurafenib helped to reduce the risk of disease worsening or death, compared to placebo plus cobimetinib and vemurafenib.
A significant and clinically meaningful improvement in PFS was demonstrated in IMspire150. The safety profile observed in the trial was consistent with the known safety profiles of the individual medicines. Results will be presented at an upcoming medical meeting and discussed with health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.
About Advanced Melanoma
Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. When melanoma is diagnosed early, it is generally a curable disease, but most people with advanced melanoma have a poor prognosis. The American Cancer Society estimates there will be more than 96,000 new cases of melanoma and 7,000 melanoma deaths this year in the United States.
In recent years, there have been significant advances in treatment for advanced melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high medical need and a steadily increasing incidence over the past 30 years.
About the IMspire150 study
IMspire150 is a phase 3, multi-center, double-blind, placebo-controlled randomized study in people with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. The study compared the efficacy and safety of atezolizumab plus cobimetinib and vemurafenib to the combination of placebo plus cobimetinib and vemurafenib. The primary endpoint of the study was investigator-assessed PFS. Key secondary endpoints include PFS by an independent review committee, overall survival, objective response rate, duration of response and other safety and pharmacokinetic measures.
About the Cobimetinib Development Collaboration
Exelixis discovered cobimetinib internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a worldwide collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop cobimetinib.
Under the terms of the collaboration, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and shares U.S. commercialization costs. Outside of the United States, Exelixis is eligible to receive royalties on any sales.
Cobimetinib is also the subject of a clinical development program aimed at evaluating its potential in combination with investigational and approved therapies in multiple disease settings.
TECENTRIQ (atezolizumab), COTELLIC (cobimetinib) and ZELBORAF (vemurafenib) are registered trademarks of Genentech, a member of the Roche Group.
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX (cabozantinib), COMETRIQ (cabozantinib), COTELLIC (cobimetinib) and MINNEBRO (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery - all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of Standard & Poor's (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Genentech's plans to present the IMspire150 data at an upcoming medical meeting and discuss the data with health authorities around the world, including the U.S. Food and Drug Administration and European Medicines Agency and Exelixis' plans to reinvest in its business to maximize the potential of the company's pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at referenced times; risks and uncertainties related regulatory review and approval processes and Daiichi Sankyo's compliance with applicable legal and regulatory requirements; uncertainties inherent in the product development process; the degree of market acceptance of treatment combinations with COTELLIC in the territories where they are approved, and Genentech's ability to obtain or maintain coverage and reimbursement for this product; Exelixis' dependence on its relationship with Genentech, including Genentech's investment in the resources necessary to successfully commercialize treatment combinations with COTELLIC in the territories where they are approved; risks and uncertainties related to regulatory review and approval processes; Exelixis' and Genentech's continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cobimetinib or other compounds with which it may be combined; Exelixis' dependence on third-party vendors for the manufacture and supply of cobimetinib; market competition, including the potential for competitors to obtain approval for generic versions of COTELLIC; Exelixis' and Genentech's ability to protect their respective intellectual property rights; changes in economic and business conditions and other factors affecting Exelixis and its partnerships discussed under the caption 'Risk Factors' in Exelixis' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 30, 2019, and in Exelixis' future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein.
Contact:
Susan Hubbard
Tel: 650-837-8194
Email: shubbard@exelixis.com
EXELIXIS, INC. 
