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ALAMEDA, Calif.–(BUSINESS WIRE)–Feb 10, 2020–
Exelixis, Inc. (NASDAQ:EXEL) today appear auspicious after-effects from the metastatic castration-resistant prostate blight (CRPC) accomplice of COSMIC-021, the appearance 1b balloon of cabozantinib (CABOMETYX ® ) in aggregate with atezolizumab (TECENTRIQ ® ) in patients with locally avant-garde or metastatic solid tumors. The abstracts will be presented on Thursday, February 13 th during Poster Session A: Prostate Blight at 11:30 a.m. – 1:00 p.m. PT and 5:30 – 6:30 p.m. PT at the 2020 American Society of Analytic Oncology’s Genitourinary Cancers Symposium (ASCO GU 2020), which is actuality captivated in San Francisco, California, February 13 – 15, 2020.
Upon enrollment, patients had to accept assessable ache per Acknowledgment Appraisal Criteria in Solid Tumors (RECIST v. 1.1) and had progressed on above-mentioned atypical hormone assay and could accept accustomed above-mentioned docetaxel for hormone astute disease. Forty-four patients were included in this acting analysis. The average chase up was 12.6 months. The cold acknowledgment amount (ORR) per RECIST v. 1.1, the trial’s primary endpoint, was 32%, including two complete responses and 12 fractional responses. Ache ascendancy amount was 80%. Among the 36 patients with high-risk analytic appearance including belly metastases and/or extra-pelvic lymph bulge metastases, the ORR was 33%. Average continuance of acknowledgment for all responding patients was 8.3 months. Among 12 patients who had an cold acknowledgment and at atomic one post-baseline prostate-specific antigen (PSA) evaluation, 67% had a PSA abatement of at atomic 50%.
“Given the poor cast for men with metastatic castration-resistant prostate cancer, assessable belly ache and/or extra-pelvic lymph bulge metastases who accept progressed on atypical hormone therapies, we are aflame to beam clinically allusive action with the aggregate of cabozantinib and atezolizumab in this COSMIC-021 cohort,” said Neeraj Agarwal, M.D., Professor, Huntsman Blight Center, University of Utah, and an investigator of the trial. “Emerging abstracts suggests a tolerable assurance contour and auspicious adeptness for this aggregate that may authority affiance for these patients with bound analysis options, potentially accouterment patients with added time afore the charge for analysis with chemotherapy. We attending avant-garde to added after-effects as the balloon progresses.”
The average analysis continuance was 6.3 months (range 1 to 18 months). No new assurance signals were articular in this aggregate cohort. Treatment-related brand 3/4 adverse contest (AEs) occurring in ≥5% of patients were fatigue (7%), diarrhea (7%) and hyponatremia (7%). One treatment-related brand 5 AE of aridity was appear in a 90-year-old patient. The cessation amount of abstraction analysis for adverse contest different to ache progression was low at 7%.
Exelixis appear on January 7, 2020 that metastatic CRPC accomplice 6 of COSMIC-021 had been broadcast to accept up to 130 patients. Based on authoritative acknowledgment from the U.S. Food & Biologic Administration (FDA), and if accurate by the analytic abstracts from the afresh broadcast absolute accomplice and added metastatic CRPC cohorts, Exelixis intends to book with the FDA for accelerated approval in a metastatic CRPC adumbration as aboriginal as 2021.
“We’re blessed to allotment these auspicious after-effects from the metastatic CRPC accomplice from COSMIC-021, our aboriginal balloon evaluating the aggregate of cabozantinib and atezolizumab,” said Gisela Schwab, M.D., President, Artefact Development and Medical Affairs and Chief Medical Officer, Exelixis. “We attending avant-garde to accepting abstracts from the best contempo amplification of this CRPC accomplice while we are additionally advancing for the admission of a appearance 3 cardinal balloon in this indication. We are aflame about the arising abstracts in metastatic CRPC and abroad and the abeyant of accumulation cabozantinib with immunotherapies in this and added difficult-to-treat bump types.”
About the COSMIC-021 Study
COSMIC-021 is a multicenter, appearance 1b, open-label abstraction that is disconnected into two parts: a dose-escalation appearance and an amplification accomplice phase. The dose-escalation appearance was advised to accept patients either with avant-garde renal corpuscle blight (RCC) with or afterwards above-mentioned systemic assay or with inoperable, locally advanced, metastatic or alternate urothelial blight (UC), (including renal, pelvis, ureter, urinary float and urethra) afterwards above-mentioned platinum-based therapy. Ultimately, all 12 patients enrolled in this date of the balloon were patients with avant-garde RCC. The dose-escalation appearance of the abstraction bent the optimal dosage of cabozantinib to be 40 mg circadian back accustomed in aggregate with atezolizumab (1200 mg beverage already every 3 weeks). These after-effects were presented at the European Society for Medical Oncology 2018 Congress.
In the amplification phase, the balloon is enrolling 24 cohorts in 12 bump types: RCC, UC, non-small corpuscle lung blight (NSCLC), CRPC, hepatocellular blight (HCC), triple-negative breast cancer, epithelial ovarian cancer, endometrial cancer, belly or gastroesophageal alliance adenocarcinoma, colorectal adenocarcinoma, arch and close cancer, and differentiated thyroid cancer. Up to 1,720 patients may accept in this appearance of the trial: anniversary amplification accomplice will initially accept about 30 patients, and up to 10 cohorts may added aggrandize acceptance consistent in up to 1,000 patients above such abeyant added amplification cohorts.
Four of the cohorts are exploratory: three are enrolling about 30 patients anniversary with avant-garde UC, CRPC or NSCLC to be advised with cabozantinib as a single-agent, and one is enrolling about 10 patients with avant-garde CRPC to be advised with single-agent atezolizumab. Exploratory cohorts accept the advantage to be broadcast up to 80 patients (cabozantinib) and 30 patients (atezolizumab) total.
Exelixis is the abstraction sponsor of COSMIC-021. Ipsen has autonomous in to participate in the balloon and is accidental to the allotment for this abstraction beneath the acceding of the companies’ accord agreement. Roche is accouterment atezolizumab for the trial.
According to the American Blight Society, about 192,000 new cases of prostate blight will be diagnosed and 33,000 bodies will die from the ache this year. 1 Prostate blight that has advance above the prostate and does not acknowledge to androgen-suppression therapies — a accepted analysis for prostate blight — is accepted as metastatic CRPC. 2 Researchers appraisal that in 2020, 43,000 bodies with prostate blight will advance to metastatic CRPC, which has a average adaptation of beneath than two years. 3,4,5
About CABOMETYX ® (cabozantinib)
In the U.S., CABOMETYX tablets are accustomed for the analysis of patients with avant-garde RCC and for the analysis of patients with HCC who accept been ahead advised with sorafenib. CABOMETYX tablets accept additionally accustomed authoritative approvals in the European Union and added countries and regions worldwide. 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.
Important Assurance Information
Hemorrhage: Astringent and baleful hemorrhages occurred with CABOMETYX. The accident of Brand 3 to 5 hemorrhagic contest was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Brand 3 or 4 hemorrhage. Do not administrate CABOMETYX to patients who accept a contempo history of hemorrhage, including hemoptysis, hematemesis, or melena.
Perforations and Fistulas: Gastrointestinal (GI) perforations, including baleful cases, occurred in 1% of CABOMETYX patients. Fistulas, including baleful cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and affection of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who acquaintance a Brand 4 fistula or a GI perforation.
Thrombotic Events: CABOMETYX added the accident of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Baleful thrombotic contest occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who advance an astute myocardial infarction or austere arterial or venous thromboembolic accident acute medical intervention.
Hypertension and Hypertensive Crisis: CABOMETYX can account hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Brand 3 and <1% Brand 4) of CABOMETYX patients. Do not admit CABOMETYX in patients with amoral hypertension. Monitor claret burden consistently during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not abundantly controlled with medical management; back controlled, resume at a bargain dose. Discontinue CABOMETYX for astringent hypertension that cannot be controlled with anti-hypertensive assay or for hypertensive crisis.
Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Brand 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until advance to Brand 1 and resume at a bargain dosage for intolerable Brand 2 diarrhea, Brand 3 diarrhea that cannot be managed with accepted antidiarrheal treatments, or Brand 4 diarrhea.
Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Brand 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until advance to Brand 1 and resume at a bargain dosage for intolerable Brand 2 PPE or Brand 3 PPE.
Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein consistently during CABOMETYX treatment. Discontinue CABOMETYX in patients who advance nephrotic syndrome.
Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can apparent as jaw pain, osteomyelitis, osteitis, cartilage erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, assiduous jaw pain, or apathetic healing of the aperture or jaw afterwards dental surgery. Perform an articulate assay above-mentioned to CABOMETYX admission and periodically during treatment. Admonish patients apropos acceptable articulate hygiene practices. Withhold CABOMETYX for at atomic 3 weeks above-mentioned to appointed dental anaplasty or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.
Impaired Anguish Healing: Anguish complications occurred with CABOMETYX. Withhold CABOMETYX for at atomic 3 weeks above-mentioned to constituent surgery. Do not administrate CABOMETYX for at atomic 2 weeks afterwards above anaplasty and until able anguish healing is observed. The assurance of resumption of CABOMETYX afterwards resolution of anguish healing complications has not been established.
Reversible Posterior Leukoencephalopathy Affection (RPLS): RPLS, a affection of subcortical vasogenic edema diagnosed by appropriate allegation on MRI, can action with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, beheld disturbances, confusion, or adapted brainy function. Discontinue CABOMETYX in patients who advance RPLS.
Embryo-Fetal Toxicity: CABOMETYX can account fetal harm. Admonish abundant women and females of changeable abeyant of the abeyant accident to a fetus. Verify the abundance cachet of females of changeable abeyant above-mentioned to initiating CABOMETYX and admonish them to use able contraception during analysis and for 4 months afterwards the aftermost dose.
The best frequently appear (≥25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.
Strong CYP3A4 Inhibitors: If coadministration with able CYP3A4 inhibitors cannot be avoided, abate the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.
Strong CYP3A4 Inducers: If coadministration with able CYP3A4 inducers cannot be avoided, access the CABOMETYX dosage. Avoid St. John’s wort.
USE IN SPECIFIC POPULATIONS
Lactation: Admonish women not to breastfeed during CABOMETYX analysis and for 4 months afterwards the final dose.
Hepatic Impairment: In patients with abstinent hepatic impairment, abate the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with astringent hepatic impairment.
Founded in 1994, Exelixis, Inc. (NASDAQ: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. Following aboriginal assignment in archetypal arrangement genetics, 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. Our analysis efforts accept resulted in four commercially accessible products, CABOMETYX ® (cabozantinib), COMETRIQ ® (cabozantinib), COTELLIC ® (cobimetinib) and MINNEBRO ® (esaxerenone), and we accept entered into partnerships with arch biologic companies to accompany these important medicines to patients worldwide. Accurate 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 addition 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. Exelixis is a affiliate of 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.
This columnist absolution contains advanced statements, including, afterwards limitation, statements accompanying to: Exelixis’ apprehension that abstracts from the CRPC accomplice of the COSMIC-021 balloon will be presented at ASCO GU 2020; the ameliorative abeyant of cabozantinib in aggregate with atezolizumab for patients with CRPC and added difficult-to-treat bump types; Exelixis’ ambition to book with the FDA for accelerated approval of the aggregate of cabozantinib and atezolizumab in a metastatic CRPC adumbration as aboriginal as 2021, based on authoritative acknowledgment from the FDA and if accurate by the analytic data; Exelixis’ affairs to admit a appearance 3 cardinal balloon in metastatic CRPC; and 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. Any statements that accredit to expectations, projections or added characterizations of approaching contest or affairs are advanced statements and are based aloft Exelixis’ accepted plans, assumptions, beliefs, expectations, estimates and projections. Advanced statements absorb risks and uncertainties. Actual after-effects and the timing of contest could alter materially from those advancing in the advanced statements as a aftereffect of these risks and uncertainties, which include, afterwards limitation: the availability of abstracts at the referenced times; risks and uncertainties accompanying to authoritative analysis and approval processes and Exelixis’ acquiescence with applicative acknowledged and authoritative requirements; the abeyant abortion of the aggregate of cabozantinib and atezolizumab to authenticate assurance and/or adeptness in approaching trials; uncertainties inherent in the artefact development process; the costs of administering analytic trials, including the adeptness or alertness of Exelixis’ accord ally to advance in the assets all-important to complete the trials; Exelixis’ assurance on third-party vendors for the development, accomplish and accumulation of cabozantinib; Exelixis’ adeptness to assure its bookish acreage rights; bazaar competition, including the abeyant for competitors to access approval for all-encompassing versions of CABOMETYX; changes in bread-and-butter and business conditions; and added factors affecting Exelixis and its development programs discussed beneath the explanation “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’ approaching filings with the SEC. All advanced statements in this columnist absolution are based on advice accessible to Exelixis as of the date of this columnist release, and Exelixis undertakes no obligation to amend or alter any advanced statements independent herein.
Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a Japanese trademark.
TECENTRIQ® (atezolizumab) is a registered brand of Genentech, a affiliate of the Roche Group.
3 Scher, H.I., Solo, K., Valant, J., Todd, M.B., Mehra, M. Prevalence of Prostate Blight Analytic States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLOS ONE. 2015; 10: e0139440.
5 Moreira, D. M., Howard, L. E., Sourbeer, K. N., et al. Predicting Time From Metastasis to Overall Adaptation in Castration-Resistant Prostate Cancer: After-effects From SEARCH. Clin Genitourin Cancer. 2017; 15: 60–66.e2.
Senior Director, Public Affairs and Advocacy Relations
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: ONCOLOGY HEALTH GENETICS CLINICAL TRIALS RESEARCH SCIENCE BIOTECHNOLOGY
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PUB: 02/10/2020 05:00 PM/DISC: 02/10/2020 05:01 PM
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