Press Release
Press Release
Cabozantinib to Be Featured in 13 Presentations at ESMO 2018 Congress
– Presentations to include results from the dose escalation stage of phase 1b COSMIC-021 study of cabozantinib in combination with atezolizumab in previously untreated advanced renal cell carcinoma –
Poster presentations will include results from the dose escalation stage of the phase 1b COSMIC-021 study of cabozantinib in combination with atezolizumab in previously untreated advanced renal cell carcinoma (RCC). Additionally, a poster discussion session will feature a late-breaking abstract evaluating the effect of PD-L1 status on clinical outcomes with cabozantinib in advanced RCC in the CABOSUN and METEOR trials.
“The data at
Cabozantinib to be featured in 13 presentations
The full
schedule of cabozantinib presentations expected at the meeting is as
follows:
Proffered Paper Session
[Abstract LBA67] “Cabozantinib in Patients with Advanced
Osteosarcomas and Ewing Sarcomas: a
Session: Sarcoma
Proffered Paper Session
Poster Discussion
[Abstract LBA34] “PD-L1 Status and Clinical Outcomes to Cabozantinib,
Sunitinib and Everolimus in Patients with Metastatic Clear-Cell RCC
Treated on CABOSUN and METEOR Clinical Trials”
Toni K.
Choueiri, M.D.,
Session:
Genitourinary Tumors, Non Prostate
Poster Discussion Session
[Abstract 1310PD] “Prospective Genome and Transcriptome Sequencing in
Advanced-Stage Neuroendocrine Neoplasms”
Leonidas Apostolidis,
M.D.,
Session:
NETs
Poster Discussion Session
Poster Presentations
[Abstract 702P] “Outcomes by Baseline Alpha-Fetoprotein (AFP) Levels
in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in
Previously Treated Advanced Hepatocellular Carcinoma (HCC)”
R.
K. Kelley, M.D.,
Session:
Poster Display Session
Poster presented
[Abstract 703P] “Assessment of Disease Burden in the Phase 3
CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Advanced
Hepatocellular Carcinoma (HCC)”
Session:
Poster Display Session
Poster presented
[Abstract 704P] “Outcomes by Prior Transarterial Chemoembolization
(TACE) in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo
(P) in Patients (pts) with Advanced Hepatocellular Carcinoma (HCC)”
Session: Poster
Display Session
Poster presented
[Abstract 1829TiP] “A Noninferiority Trial of Cabozantinib (C)
Comparing 60 mg vs 140 mg Orally per Day to Evaluate the Efficacy and
Safety in Patients (pts) with Progressive, Metastatic Medullary Thyroid
Cancer (MTC)”
Session:
Poster Display Session
Poster presented
[Abstract 1913P] “A Guided and Personnalized Treatment in Metastatic
Breast Cancer: Optimisation of Gene and Protein Expression in Tumor
Tissue”
Emmanuel Seront, M.D.,
Session:
Poster Display Session
Poster presented
[Abstract 872P] “Phase 1b Study (COSMIC-021) of Cabozantinib in
Combination with Atezolizumab: Results of the Dose Escalation Stage in
Patients (pts) with Treatment-Naïve Advanced Renal Cell Carcinoma (RCC)”
Session:
Poster Display Session
Poster presented
[Abstract 893P] “Cabozantinib in Metastatic Renal Cell Carcinoma
(mRCC): Data from UK Expanded Access Program (EAP)”
Session:
Poster Display Session
Poster presented
[Abstract 879P] “Activity of Cabozantinib (cabo) after PD-1/PD-L1
Immune Checkpoint Blockade (
Session: Poster
Display Session
Poster presented
[Abstract 882P] “Potent Natural Killer (NK) and Myeloid Blood Cell
Remodeling by Cabozantinib (Cabo) in Pretreated Metastatic Renal Cell
Carcinoma (mRCC) Patients (pts)”
Session:
Poster Display Session
Poster presented
[Abstract 889P] “Clinical Outcomes of Patients with Metastatic Renal
Cell Carcinoma (mRCC) Treated with Vascular Endothelial Growth Factor
Receptor (VEGFR) Tyrosine Kinase Inhibitors (TKI) and Mammalian Target
of Rapamycin Inhibitors (mTORI) after Immuno-oncology (IO) Checkpoint
Inhibitors”
Session: Poster
Display Session
Poster presented
About CABOMETYX® (cabozantinib)
CABOMETYX tablets are approved in
U.S. Important Safety Information
- Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In two RCC studies, the incidence of Grade ≥ 3 hemorrhagic events was 3% in CABOMETYX-treated patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
- Gastrointestinal (GI) Perforations and Fistulas: In RCC studies, fistulas were reported in 1% of CABOMETYX-treated patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, gastrointestinal (GI) perforations were reported in 1% of CABOMETYX-treated patients. Monitor patients for symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula which cannot be appropriately managed or a GI perforation.
- Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. In RCC studies, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
- Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension, including hypertensive crisis. In RCC studies, hypertension was reported in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
- Diarrhea: In RCC studies, diarrhea occurred in 74% of patients treated with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
- Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients treated with CABOMETYX. Grade 3 PPE occurred in 8% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
- Embryo-fetal Toxicity may be associated with CABOMETYX. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.
- Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.
- Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
- Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
- Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
- Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.
Please see accompanying full Prescribing Information
https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
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This press release contains forward-looking statements, including,
without limitation, statements related to: the planned presentation of
data from clinical trials of cabozantinib at the
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Source:
Investors:
Exelixis, Inc.
Susan Hubbard,
650-837-8194
EVP, Public Affairs and
Investor
Relations
shubbard@exelixis.com
or
Media:
Exelixis,
Inc.
Lindsay Treadway, 650-837-7522
Senior
Director, Public Affairs and Advocacy Relations
ltreadway@exelixis.com