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– Balloon after-effects formed the base of authoritative filings in the U.S. and European Union for CABOMETYX® (cabozantinib) for ahead advised avant-garde hepatocellular blight –



Exelixis, Inc. (EXEL) today appear that The New England Journal of Medicine (NEJM) appear after-effects from the CELESTIAL appearance 3 cardinal balloon of cabozantinib in patients with ahead advised avant-garde hepatocellular blight (HCC).1 The data, originally presented at the 2018 American Society of Analytic Oncology’s Gastrointestinal Cancers Symposium (ASCO-GI) in January, authenticate that cabozantinib provided a statistically cogent and clinically allusive advance in all-embracing adaptation (OS) against placebo.

“Patients with this anatomy of avant-garde alarmist blight accept actual bound assay options already their ache progresses afterward assay with sorafenib,” said Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Blight Center, New York and advance investigator on CELESTIAL. “These after-effects advance that, if approved, cabozantinib could become an important accession to the assay mural that may advice apathetic ache progression and, critically, advance adaptation for these patients.”



Exelixis appear in May 2018 that the U.S. Food and Biologic Administration (FDA) accustomed the company’s added New Biologic Appliance (sNDA) for CABOMETYX® (cabozantinib) tablets as a assay for patients with ahead advised HCC. The filing has been assigned a Prescription Biologic User Fee Act activity date of January 14, 2019. Exelixis’ accomplice Ipsen accustomed validation by the European Medicines Agency in March 2018 for its appliance for aberration to the CABOMETYX business allotment to accommodate the new adumbration for patients with ahead advised avant-garde HCC.

“The advertisement of the CELESTIAL balloon after-effects in a peer-reviewed advertisement as celebrated as NEJM added validates the accent of these abstracts for the avant-garde alarmist blight community,” said Gisela Schwab, M.D., President, Artefact Development and Medical Affairs and Chief Medical Officer, Exelixis. “We’re alive carefully with the FDA as they assay our sNDA in adjustment to accompany CABOMETYX to this growing accommodating citizenry as bound as possible.”

Median OS in CELESTIAL was 10.2 months with cabozantinib against 8.0 months with placebo (HR 0.76, 95 percent CI 0.63-0.92; p=0.0049). Average progression-free adaptation (PFS) was added than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo (HR 0.44, 95 percent CI 0.36-0.52; p<0.0001). Cold acknowledgment ante per RECIST 1.1 were 4 percent with cabozantinib and 0.4 percent with placebo (p=0.0086). Ache ascendancy (partial acknowledgment or abiding disease) was accomplished by 64 percent of patients in the cabozantinib accumulation compared with 33 percent of patients in the placebo group.

In a subgroup assay of patients whose abandoned above-mentioned assay for avant-garde HCC was sorafenib (70 percent of patients in the study), average OS was 11.3 months with cabozantinib against 7.2 months with placebo (HR 0.70, 95 percent CI 0.55-0.88). Average PFS in the subgroup was 5.5 months with cabozantinib against 1.9 months with placebo (HR 0.40, 95 percent CI 0.32-0.50).

Adverse contest were constant with the accepted assurance contour of cabozantinib. The best accepted (≥10 percent) brand 3 or 4 adverse contest in the cabozantinib accumulation compared to the placebo accumulation were palmar-plantar erythrodysesthesia (17 percent vs. 0 percent), hypertension (16 percent vs. 2 percent), added aspartate aminotransferase (12 percent vs. 7 percent), fatigue (10 percent vs. 4 percent) and diarrhea (10 percent vs. 2 percent). Treatment-related brand 5 adverse contest occurred in six patients in the cabozantinib accumulation (hepatic failure, esophagobronchial fistula, aperture attitude thrombosis, high gastrointestinal hemorrhage, pulmonary array and hepatorenal syndrome) and in one accommodating in the placebo accumulation (hepatic failure). Sixteen percent of patients in the cabozantinib arm and three percent of patients in the placebo arm discontinued assay due to treatment-related adverse events.

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About the CELESTIAL Study

CELESTIAL is a randomized, double-blind, placebo-controlled abstraction of cabozantinib in patients with avant-garde HCC conducted at added than 100 sites globally in 19 countries. The balloon was advised to accept 760 patients with avant-garde HCC who accustomed above-mentioned sorafenib and may accept accustomed up to two above-mentioned systemic blight therapies for HCC and had able alarmist function. Enrollment of the balloon was completed in September 2017. Patients were randomized 2:1 to accept 60 mg of cabozantinib already circadian or placebo and were stratified based on assay of the ache (hepatitis C, hepatitis B or other), geographic arena (Asia against added regions) and attendance of extrahepatic advance and/or macrovascular aggression (yes or no). No cross-over was accustomed amid the abstraction accoutrements during the addled assay appearance of the trial. The primary endpoint for the balloon is OS, and accessory endpoints accommodate cold acknowledgment amount and PFS. Exploratory endpoints accommodate patient-reported outcomes, biomarkers and safety.

Story Continues

In October 2017, Exelixis appear that the absolute abstracts ecology board for the CELESTIAL abstraction recommended that the balloon be chock-full for adeptness afterward assay at the additional planned acting analysis, with cabozantinib accouterment a statistically cogent and clinically allusive advance in OS compared with placebo in patients with ahead advised avant-garde HCC. In March 2017, the FDA accepted drop biologic appellation to cabozantinib for the assay of avant-garde HCC.

About HCC

Liver blight is the second-leading account of blight afterlife worldwide, accounting for added than 700,000 deaths and about 800,000 new cases anniversary year.2 In the U.S., the accident of alarmist blight has added than tripled back 1980.3 HCC is the best accepted anatomy of alarmist cancer, authoritative up about three-fourths of the estimated about 42,000 new cases in the U.S. in 2018.3 HCC is the fastest-rising account of cancer-related afterlife in U.S.4 After treatment, patients with avant-garde HCC usually survive beneath than 6 months.5

About CABOMETYX® (cabozantinib)

CABOMETYX tablets are accustomed in the United States for the assay of patients with avant-garde renal corpuscle blight (RCC). CABOMETYX tablets are additionally accustomed in the European Union, Norway, Iceland, Australia, Switzerland and South Korea for the assay of avant-garde RCC in adults who accept accustomed above-mentioned VEGF-targeted therapy, and in the European Union for ahead basic intermediate- or poor-risk avant-garde RCC. On March 28, 2018, Ipsen appear that the European Medicines Agency accurate its appliance for a new adumbration for cabozantinib as a assay for ahead advised avant-garde HCC in the European Union. In 2016, Exelixis accepted Ipsen absolute rights for the commercialization and added analytic development of cabozantinib alfresco of the United States and Japan. In 2017, Exelixis accepted absolute rights to Takeda Biologic Aggregation Bound for the commercialization and added analytic development of cabozantinib for all approaching break in Japan, including RCC.

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CABOMETYX is not adumbrated for ahead advised avant-garde HCC.

Please see Important Assurance Advice beneath and abounding U.S. prescribing advice at https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

U.S. Important Assurance Information

Please see accompanying abounding Prescribing Information

https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

About Exelixis

Founded in 1994, Exelixis, Inc. (EXEL) is a commercially successful, oncology-focused biotechnology aggregation that strives to advance the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Afterward aboriginal assignment in archetypal abiogenetic systems, we accustomed a ample biologic analysis and development belvedere that has served as the foundation for our connected efforts to accompany new blight therapies to patients in need. We apparent our three commercially accessible products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib) and COTELLIC® (cobimetinib), and accept entered into partnerships with arch biologic companies to accompany these important medicines to patients worldwide. Supported by revenues from our marketed articles and collaborations, we are committed to carefully reinvesting in our business to aerate the abeyant of our pipeline. We are accession our absolute ameliorative assets with targeted business development activities and centralized biologic analysis – all to bear the abutting bearing of Exelixis medicines and advice patients balance stronger and alive longer. In July 2018, Exelixis was added to the Accepted & Poor’s (S&P) MidCap 400 index, which measures the achievement of assisting mid-sized companies. For added advice about Exelixis, amuse appointment www.exelixis.com, chase @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Exelixis Forward-Looking Account Disclaimer

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This columnist absolution contains avant-garde statements, including, after limitation, statements accompanying to: the ameliorative abeyant of cabozantinib as a assay advantage for patients with ahead treaded avant-garde HCC, if approved; the authoritative assay process, including Exelixis’ absorbed to abide to assignment carefully with the FDA as they assay the appliance for cabozantinib as a assay for patients with ahead advised avant-garde HCC; Exelixis’ affairs to reinvest in its business to aerate the abeyant of the company’s pipeline, including through targeted business development activities and centralized biologic discovery; and Exelixis’ mission to bear the abutting bearing of Exelixis medicines and advice patients balance stronger and alive longer. Words such as “could” “may,” “commitment,” “potential,” “intend,” or added agnate expressions analyze avant-garde statements, but the absence of these words does not necessarily beggarly that a account is not forward-looking. In addition, any statements that accredit to expectations, projections or added characterizations of approaching contest or affairs are avant-garde statements. These avant-garde statements are based aloft Exelixis’ accepted plans, assumptions, beliefs, expectations, estimates and projections. Avant-garde statements absorb risks and uncertainties. Actual after-effects and the timing of contest could alter materially from those advancing in the avant-garde statements as a aftereffect of these risks and uncertainties, which include, after limitation: risks and uncertainties accompanying to authoritative assay and approval processes and Exelixis’ acquiescence with applicative acknowledged and authoritative requirements; bazaar accepting of CABOMETYX, COMETRIQ, and COTELLIC and the availability of advantage and agreement for these products; the accident that hasty developments could abnormally affect the commercialization of CABOMETYX, COMETRIQ, and COTELLIC; risks accompanying to the abeyant abortion of cabozantinib and cobimetinib to authenticate assurance and adeptness in analytic testing; Exelixis’ adeptness and the adeptness of its collaborators to conduct analytic trials of cabozantinib and cobimetinib, both abandoned and in aggregate with added therapies, acceptable to accomplish a absolute completion; Exelixis’ assurance on its relationships with its accord partners, including, the akin of their advance in the assets all-important to auspiciously commercialize partnered articles in the territories area they are approved; the akin of costs associated with Exelixis’ commercialization, analysis and development, in-licensing or accretion of artefact candidates, and added activities; Exelixis’ assurance on third-party vendors for the development, accomplish and accumulation of its products; Exelixis’ adeptness to assure the company’s bookish acreage rights; bazaar competition, including the abeyant for competitors to access approval for all-encompassing versions of Exelixis’ marketed products; changes in bread-and-butter and business conditions, and added factors discussed beneath the explanation “Risk Factors” in Exelixis’ anniversary address on Anatomy 10-Q filed with the Securities and Exchange Commission (SEC) on May 2, 2018, and in Exelixis’ approaching filings with the SEC. The avant-garde statements fabricated in this columnist absolution allege abandoned as of the date of this columnist release. Exelixis especially disclaims any duty, obligation or adventure to absolution about any updates or revisions to any avant-garde statements independent herein to reflect any change in Exelixis’ expectations with attention thereto or any change in events, altitude or affairs on which any such statements are based.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.

References:

1 Abou-Alfa, G, Meyer T, Cheng AL, et al. Cabozantinib in patients with avant-garde and avant-garde hepatocellular carcinoma. N Engl J Med. 2018. 379:54-63.

2 Blight Accident and Mortality Worldwide. Alarmist Cancer. International Agency for Analysis on Cancer, GLOBOCAN 2012. Accessible at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed July 2018.

3 American Blight Society: Blight Facts and Figures 2018. Accessible at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2018/cancer-facts-and-figures-2018.pdf. Accessed July 2018.

4 Mittal S, El-Serag HB. Epidemiology of HCC: Consider the Population. J Clin Gastroenterol. 2013. 47:S2-S6.

5 Weledji E, Orock G, Ngowe M, NsaghaD. How austere is hepatocellular carcinoma? Ann Med Surg. 2014. 3:71-76.

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