– Based on continued encouraging efficacy
and safety data, metastatic castration-resistant prostate cancer
cohort further expanded to 130 patients –
– Initial data to be presented on February
13 at the 2020 American Society of Clinical Oncology’s
Genitourinary Cancers Symposium (ASCO GU 2020) in San Francisco, CA
–
Exelixis, Inc. (NASDAQ: EXEL) today announced that based on
continued encouraging efficacy and safety data, the company plans
to further expand the metastatic castration-resistant prostate
cancer (CRPC) cohort of COSMIC-021, the phase 1b trial of
cabozantinib (CABOMETYX®) in combination with atezolizumab
(TECENTRIQ®) in patients with locally advanced or metastatic solid
tumors. The cohort, which was previously expanded from 30 to 80
patients in July 2019, will now include up to 130 patients.
“We continue to see encouraging efficacy and safety data from
the prostate cancer cohort in COSMIC-021,” said Gisela Schwab,
M.D., President, Product Development and Medical Affairs and Chief
Medical Officer, Exelixis. “Expanding this cohort by an additional
50 patients will allow us to further document how the combination
of cabozantinib and atezolizumab may benefit this patient
population as we assess our potential regulatory plans for the
combination and prepare to initiate a phase 3 pivotal trial. We
look forward to the presentation of initial data from this cohort
of CRPC patients at ASCO GU 2020 in February.”
Based on preliminary encouraging activity, as determined by
response assessment per Response Evaluation Criteria in Solid
Tumors (version 1.1) (RECISTv1.1), and safety data of patients
enrolled in the metastatic CRPC cohort, 50 additional patients with
metastatic CRPC (130 total) who have histologically or
cytologically confirmed adenocarcinoma of the prostate are being
enrolled in the trial.
Initial data from the CRPC cohort in COSMIC-021 will be
presented at ASCO GU 2020 in San Francisco on Thursday, February
13th during Poster Session A: Prostate Cancer at 11:30 a.m. – 1:00
p.m. PT and again at 5:30 – 6:30 p.m. PT.
COSMIC-021 includes 24 cohorts and aims to enroll up to 1,732
patients with advanced or metastatic solid tumors including CRPC,
renal cell carcinoma (RCC), hepatocellular carcinoma (HCC),
non-small cell lung cancer (NSCLC), colorectal cancer, ovarian
cancer, and urothelial carcinoma (UC), among others. The primary
objective in the expansion stage of this trial is to determine the
objective response rate in each cohort. More information about the
currently enrolling cohorts in this trial is available at
ClinicalTrials.gov. To date, early data from various cohorts of
this study have informed the initiation or planned initiation of
several phase 3 pivotal trials, evaluating the combination in
advanced HCC, CRPC, NSCLC and RCC.
TECENTRIQ® (atezolizumab) is a registered trademark of
Genentech, a member of the Roche Group.
About the COSMIC-021 Study
COSMIC-021 is a multicenter, phase 1b, open-label study that is
divided into two parts: a dose-escalation phase and an expansion
cohort phase. The dose-escalation phase was designed to enroll
patients either with advanced RCC with or without prior systemic
therapy or with inoperable, locally advanced, metastatic or
recurrent UC (including renal, pelvis, ureter, urinary bladder and
urethra) after prior platinum-based therapy. Ultimately, all 12
patients enrolled in this stage of the trial were patients with
advanced RCC. The dose-escalation phase of the study determined the
optimal dose of cabozantinib to be 40 mg daily when given in
combination with atezolizumab (1200 mg infusion once every 3
weeks). These results were presented at the European Society for
Medical Oncology 2018 Congress.
In the expansion phase, the trial is enrolling 24 cohorts in 12
tumor types: RCC, UC, NSCLC, CRPC, HCC, triple-negative breast
cancer, epithelial ovarian cancer, endometrial cancer, gastric or
gastroesophageal junction adenocarcinoma, colorectal
adenocarcinoma, head and neck cancer, and differentiated thyroid
cancer. Up to 1,720 patients may enroll in this phase of the trial:
each expansion cohort will initially enroll approximately 30
patients, and up to 10 cohorts may expand enrollment up to 1,000
additional patients in the expansion phase.
Four of the cohorts are exploratory: three are enrolling
approximately 30 patients each with advanced UC, CRPC or NSCLC to
be treated with cabozantinib as a single-agent, and one is
enrolling approximately 10 patients with advanced CRPC to be
treated with single-agent atezolizumab. Exploratory cohorts have
the option to be expanded up to 80 patients (cabozantinib) and 30
patients (atezolizumab) total.
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of
patients with advanced RCC and for the treatment of patients with
HCC who have been previously treated with sorafenib. CABOMETYX
tablets have also received regulatory approvals in the European
Union and additional countries and regions worldwide. In 2016,
Exelixis granted Ipsen exclusive rights for the commercialization
and further clinical development of cabozantinib outside of the
United States and Japan. In 2017, Exelixis granted exclusive rights
to Takeda Pharmaceutical Company Limited for the commercialization
and further clinical development of cabozantinib for all future
indications in Japan.
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 occurred with CABOMETYX. The incidence of Grade 3 to 5
hemorrhagic events was 5% in CABOMETYX patients. Discontinue
CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX
to patients who have a recent history of hemorrhage, including
hemoptysis, hematemesis, or melena.
- Perforations and Fistulas:
GastrointestinaI (GI) perforations, including fatal cases, occurred
in 1% of CABOMETYX patients. Fistulas, including fatal cases,
occurred in 1% of CABOMETYX patients. Monitor patients for signs
and symptoms of perforations and fistulas, including abscess and
sepsis. Discontinue CABOMETYX in patients who experience a fistula
that cannot be appropriately managed or a GI perforation.
- Thrombotic Events: CABOMETYX
increased the risk of thrombotic events. Venous thromboembolism
occurred in 7% (including 4% pulmonary embolism) and arterial
thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic
events occurred in CABOMETYX patients. Discontinue CABOMETYX in
patients who develop an acute myocardial infarction or serious
arterial or venous thromboembolic event requiring medical
intervention.
- Hypertension and Hypertensive
Crisis: CABOMETYX can cause hypertension, including
hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and
<1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in
patients with uncontrolled hypertension. Monitor blood pressure
regularly during CABOMETYX treatment. Withhold CABOMETYX for
hypertension that is not adequately controlled with medical
management; when controlled, resume at a reduced dose. Discontinue
CABOMETYX for severe hypertension that cannot be controlled with
anti-hypertensive therapy or for hypertensive crisis.
- Diarrhea: Diarrhea occurred in
63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of
CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1
and resume at a reduced dose for intolerable Grade 2 diarrhea,
Grade 3 diarrhea that cannot be managed with standard antidiarrheal
treatments, or Grade 4 diarrhea.
- Palmar-Plantar Erythrodysesthesia
(PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE
occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until
improvement to Grade 1 and resume at a reduced dose for intolerable
Grade 2 PPE or Grade 3 PPE.
- Proteinuria: Proteinuria
occurred in 7% of CABOMETYX patients. Monitor urine protein
regularly during CABOMETYX treatment. Discontinue CABOMETYX in
patients who develop nephrotic syndrome.
- Osteonecrosis of the Jaw (ONJ):
ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as
jaw pain, osteomyelitis, osteitis, bone erosion, tooth or
periodontal infection, toothache, gingival ulceration or erosion,
persistent jaw pain, or slow healing of the mouth or jaw after
dental surgery. Perform an oral examination prior to CABOMETYX
initiation and periodically during treatment. Advise patients
regarding good oral hygiene practices. Withhold CABOMETYX for at
least 28 days prior to scheduled dental surgery or invasive dental
procedures. Withhold CABOMETYX for development of ONJ until
complete resolution.
- Wound Complications: Wound
complications were reported with CABOMETYX. Stop CABOMETYX at least
28 days prior to scheduled surgery. Resume CABOMETYX after surgery
based on clinical judgment of adequate wound healing. Withhold
CABOMETYX in patients with dehiscence or wound healing
complications requiring medical intervention.
- Reversible Posterior
Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of
subcortical vasogenic edema diagnosed by characteristic finding on
MRI, can occur with CABOMETYX. Evaluate for RPLS in patients
presenting with seizures, headache, visual disturbances, confusion,
or altered mental function. Discontinue CABOMETYX in patients who
develop RPLS.
- Embryo-Fetal Toxicity: CABOMETYX
can cause fetal harm. Advise pregnant women and females of
reproductive potential of the potential risk to a fetus. Verify the
pregnancy status of females of reproductive potential prior to
initiating CABOMETYX and advise them to use effective contraception
during treatment and for 4 months after the last dose.
- Adverse Reactions: The most
commonly reported (≥25%) adverse reactions are: diarrhea, fatigue,
decreased appetite, PPE, nausea, hypertension, and vomiting.
- Strong CYP3A4 Inhibitors: If
coadministration with strong CYP3A4 inhibitors cannot be avoided,
reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit
juice.
- Strong CYP3A4 Inducers: If
coadministration with strong CYP3A4 inducers cannot be avoided,
increase the CABOMETYX dosage. Avoid St. John’s wort.
- Lactation: Advise women not to
breastfeed during CABOMETYX treatment and for 4 months after the
final dose.
- Hepatic Impairment: In patients
with 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.
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 the Standard & Poor’s
(S&P) MidCap 400 index, which measures the performance of
profitable mid-sized companies. For more information
about Exelixis, please visit www.exelixis.com, follow
@ExelixisInc on Twitter or like Exelixis,
Inc. on Facebook.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
plans to further expand the metastatic CRPC cohort of COSMIC-021 to
include up to 130 patients and Exelixis’ belief that this expansion
will allow Exelixis to further understand how the combination of
cabozantinib and atezolizumab may benefit this patient population;
Exelixis’ potential regulatory plans for the combination of
cabozantinib and atezolizumab in patients with metastatic CRPC and
preparations to initiate a phase 3 pivotal trial; Exelixis’ plans
to present initial data from this cohort of metastatic CRPC
patients at ASCO GU 2020; Exelixis’ plans to initiate several phase
3 pivotal trials evaluating the combination of cabozantinib and
atezolizumab in CRPC, NSCLC and RCC based on early data from
various cohorts of COSMIC-021; 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 the
referenced times; risks and uncertainties related to regulatory
review and approval processes and Exelixis’ compliance with
applicable legal and regulatory requirements; the potential failure
of the combination of cabozantinib and atezolizumab to demonstrate
safety and/or efficacy in COSMIC-021 or in future phase 3 pivotal
trials; uncertainties inherent in the product development process;
the costs of conducting clinical trials, including the ability or
willingness of Exelixis’ collaboration partners to invest in the
resources necessary to complete the trials; Exelixis’ dependence on
third-party vendors for the development, manufacture and supply of
cabozantinib; Exelixis’ ability to protect its intellectual
property rights; market competition, including the potential for
competitors to obtain approval for generic versions of CABOMETYX;
changes in economic and business conditions; and other factors
affecting Exelixis and its development programs 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.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a
Japanese trademark.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200107005227/en/
Investors Contact:Susan HubbardEVP, Public Affairs
andInvestor RelationsExelixis, Inc.(650)
837-8194shubbard@exelixis.com
Media Contact:Lindsay TreadwaySenior Director, Public
Affairs and Advocacy RelationsExelixis, Inc.(650)
837-7522ltreadway@exelixis.com
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