Press Release
Press Release
Cabozantinib to Be Featured in 15 Presentations at ASCO 2018 Annual Meeting
– Cabozantinib data in a range of tumor types, including advanced
hepatocellular carcinoma and advanced renal cell carcinoma, to be
presented at
– Follow-up data from the phase 1 trial of cabozantinib in combination with nivolumab with or without ipilimumab in metastatic genitourinary cancers to be highlighted –
Poster presentations will include detailed subset results from the
CELESTIAL phase 3 pivotal trial in advanced hepatocellular carcinoma
(HCC) comparing outcomes by age and in patients whose only prior
treatment was sorafenib. CELESTIAL was the basis for Exelixis’
supplemental New Drug Application filed with the
“We’re excited about the potential of cabozantinib, both alone and in
combination with other therapies, across a range of difficult-to-treat
cancers and look forward to presenting data from our clinical trials in
genitourinary cancers, advanced hepatocellular carcinoma and other tumor
types,” said
Cabozantinib to be featured in 15 presentations
The full
schedule of cabozantinib presentations expected at the meeting is as
follows:
Poster Discussion
[Abstract 4019] “Cabozantinib (C) versus Placebo (P) in Patients
(pts) with Advanced Hepatocellular Carcinoma (HCC) who have Received
Prior Sorafenib: Results from the Randomized Phase 3 CELESTIAL Trial”
Ghassan
K. Abou-Alfa, M.D.,
Session:
Gastrointestinal (Noncolorectal) Cancer
Poster presented
Discussed at the Poster
Discussion Session on
Poster Presentations
[Abstract 4528] “Clinical Efficacy Of Cabozantinib Plus Nivolumab
(CaboNivo) and CaboNivo Plus Ipilimumab (CaboNivoIpi) in Patients (pts)
with Chemotherapy-refractory Metastatic Urothelial Carcinoma (mUC)
either Naïve (n) or Refractory (r) to Checkpoint Inhibitor (CPI)”
Session: Genitourinary (Nonprostate) Cancer
Poster
presented
[Abstract 4556] “Quality-Adjusted Time without Symptoms or Toxicity
(Q-TWiST): Analysis of Cabozantinib (Cabo) vs Sunitinib (Sun) in
Patients with Advanced Renal Cell Carcinoma (aRCC) of Intermediate or
Poor Risk (Alliance A031203)”
Session: Genitourinary
(Nonprostate) Cancer
Poster presented
[Abstract 4579] “Cabozantinib (Cabo) in Advanced Non-clear Cell Renal
Cell Carcinoma (nccRCC): A Retrospective Multicenter Analysis”
Session:
Genitourinary (Nonprostate) Cancer
Poster presented
[Abstract TPS4593] “A Phase I-II Study to Evaluate Safety and
Efficacy of the Combination of Niraparib plus Cabozantinib in Patients
with Advanced Kidney/Urothelial Carcinoma”
Daniel E.
Castellano, M.D., Hospital 12 de Octubre
Session: Genitourinary
(Nonprostate) Cancer
Poster presented
[Abstract TPS4598] “A Phase 3, Randomized, Open-Label Study of
Nivolumab Combined with Cabozantinib vs Sunitinib in Patients with
Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (RCC;
CheckMate 9ER)”
Session: Genitourinary (Nonprostate) Cancer
Poster
presented
[Abstract TPS4601] “CANTATA: A Randomized Phase 2 Study of CB-839 in
Combination with Cabozantinib vs. Placebo with Cabozantinib in Patients
with Advanced/Metastatic Renal Cell Carcinoma”
Session:
Genitourinary (Nonprostate) Cancer
Poster presented
[Abstract TPS4603] “CABOPRE: Phase II Study of Cabozantinib Prior to
Cytoreductive Nephrectomy (CN) in Locally Advanced and/or Metastatic
Renal Cell Carcinoma (mRCC)”
Session: Genitourinary (Nonprostate) Cancer
Poster
presented
[Abstract 1026] “A Phase II Study of Cabozantinib (Cabo) Alone or in
Combination with Trastuzumab (T) in Patients (pts) with Breast Cancer
Brain Metastases (BCBM)”
Session: Breast Cancer – Metastatic
Poster
presented
[Abstract TPS1119] “A Phase II Study of Nivolumab in Combination with
Cabozantinib for Metastatic Triple-Negative Breast Cancer (mTNBC)”
Session:
Breast Cancer – Metastatic
Poster presented
[Abstract 6088] “A Phase II Trial of Cabozantinib (CABO) for the
Treatment of Radioiodine (RAI)-Refractory Differentiated Thyroid
Carcinoma (DTC) in the First-line Setting”
Session:
Head and Neck Cancer
Poster presented
[Abstract 3555] “A Phase I/II Trial of Cabozantinib (C) with or
without Panitumumab (P) in Patients (pts) with RAS Wild-Type (WT)
Metastatic Colorectal Cancer (mCRC): Clinical Outcomes in Pts with MET
Amplification (amp) Detected in Blood”
Session: Gastrointestinal
(Colorectal) Cancer
Poster presented
[Abstract 4088] “Outcomes in Patients (pts) who had Received
Sorafenib (S) as the Only Prior Systemic Therapy in the Phase 3
CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Advanced
Hepatocellular Carcinoma (HCC)”
Session: Gastrointestinal
(Noncolorectal) Cancer
Poster presented
[Abstract 4090] “Outcomes Based on Age in the Phase 3 CELESTIAL Trial
of Cabozantinib (C) versus Placebo (P) in Patients (pts) with Advanced
Hepatocellular Carcinoma (HCC)”
Session: Gastrointestinal
(Noncolorectal) Cancer
Poster presented
[Abstract TPS4157] “A Phase II Trial of Cabozantinib and Erlotinib
for Patients with EGFR and c-MET Co-expressing Metastatic Pancreatic
Adenocarcinoma”
Session: Gastrointestinal (Noncolorectal) Cancer
Poster
presented
About the CELESTIAL Study
CELESTIAL is a randomized,
double-blind, placebo-controlled study of cabozantinib in patients with
advanced HCC conducted at more than 100 sites globally in 19 countries.
The trial was designed to enroll 760 patients with advanced HCC who
received prior sorafenib and may have received up to two prior systemic
cancer therapies for HCC and had adequate liver function. Enrollment of
the trial was completed in
About Genitourinary Cancers
Genitourinary cancers are those
that affect the urinary tract, bladder, kidneys, ureter, prostate,
testicles, penis or adrenal glands — parts of the body involved in
reproduction and excretion — and include renal cell carcinoma (RCC) and
urothelial carcinoma.1
The American Cancer Society’s 2018 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12 percent, with no identified cure for the disease.4 Approximately 30,000 patients in the U.S. and 70,000 globally require treatment.5
Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.6 Urothelial carcinoma occurs mainly in older people; 90 percent of patients with bladder cancer are 55 years or older.7 Bladder cancer is the fourth most common cancer in men and accounts for about five percent of all new cases of cancer in the U.S. each year.7,8 In 2015, an estimated 708,000 people were living with bladder cancer in the U.S.8
About HCC
Liver cancer is the second-leading cause of cancer
death worldwide, accounting for more than 700,000 deaths and nearly
800,000 new cases each year.9 In the U.S., the incidence of
liver cancer has more than tripled since 1980.2 HCC is the
most common form of liver cancer, making up about three-fourths of the
estimated nearly 42,000 new cases in the U.S. in 2018. HCC is the
fastest-rising cause of cancer-related death in U.S.10
Without treatment, patients with advanced HCC usually survive less than
6 months.11
About CABOMETYX® (cabozantinib)
CABOMETYX
tablets are approved in
Please see Important Safety Information below and full U.S. prescribing information at https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
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 at the upcoming
2018 Annual Meeting of the
# # #
1
2
3Jonasch, E., Gao, J.,
Rathmell, W., Renal cell carcinoma. BMJ. 2014; 349:g4797.
4Ko, J., Choueiri, T., et al. First-, second- third-line therapy for
mRCC: benchmarks for trial design from the IMDC.
5Decision
Resources Report: Renal Cell Carcinoma.
6Hurwitz, M. et al. Urothelial and
Kidney Cancers. Cancer Management. http://www.cancernetwork.com/cancer-management/urothelial-and-kidney-cancers.
Accessed
7
8
9Cancer Incidence and
Mortality Worldwide. Liver Cancer.
10Mittal S, El-Serag
HB. Epidemiology of HCC: Consider the Population.
11Weledji
E, Orock G, Ngowe M, NsaghaD. How grim is hepatocellular carcinoma? Annals
of Medicine and Surgery. 2014. 3:71-76.
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Source:
Exelixis, Inc.
Investors:
Susan Hubbard,
(650) 837-8194
EVP, Public Affairs and Investor Relations
shubbard@exelixis.com
or
Media:
Lindsay
Treadway, (650) 837-7522
Senior Director, Public Affairs and
Advocacy Relations
ltreadway@exelixis.com