FDA-approved plasma-based companion
diagnostic provides advantages for patients and practices
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the
U.S. Food and Drug Administration (FDA) approved the FoundationOne®
Liquid CDx, Foundation Medicine’s comprehensive liquid biopsy test
for all solid tumors with multiple companion diagnostic
indications, including for Rubraca ® (rucaparib) tablets, recently
approved for the treatment of adult patients with a deleterious
BRCA mutation (germline and/or somatic)-associated metastatic
castration-resistant prostate cancer (mCRPC) who have been treated
with androgen receptor-directed therapy and a taxane-based
chemotherapy.i,ii FoundationOne Liquid CDx is intended for use by
health care professionals to help inform cancer treatment decisions
in accordance with FDA-approved labeling and professional
guidelines for patients with solid tumors.
FoundationOne Liquid CDx is intended to be used as a companion
diagnostic to identify patients who may benefit from treatment with
specific FDA-approved targeted therapies, including Rubraca, the
first PARP inhibitor approved for the treatment of BRCA1/2-mutant
mCRPC.
“Tumors with BRCA mutations are by far the most responsive to
PARP inhibitors in metastatic castration-resistant prostate cancer,
and when we started development of Rubraca for mCRPC, we knew it
was important to develop a plasma-based companion diagnostic for
physician and patient ease of use,” said Patrick J. Mahaffy,
President and CEO of Clovis Oncology. “What we could not have
foreseen was how important a plasma-based test would be in this
COVID-19 environment, in which even important procedures, such as
tissue-based biopsies, can be difficult to schedule for patients.
We are pleased that the FDA has approved a plasma-based companion
diagnostic to identify mCRPC patients who may benefit from
treatment with Rubraca.”
The objective response rate in BRCA positive patients as
determined by FoundationOne Liquid CDx was 46% (95% CI, 31-63),
comparable to 44% (95% CI, 31-57) as determined by clinical trial
assays for patients enrolled in TRITON2, highlighting the utility
and consistency of using a liquid biopsy test for patient
selection.i,iii
“Now that we have drugs that specifically benefit patients with
BRCA mutations, the ability to identify who has these mutations is
paramount,” said Professor Celestia S. Higano, MD FACP, University
of Washington School of Medicine. “In contrast to tissue biopsy, a
liquid biopsy is a blood-plasma test that is less invasive than a
tissue biopsy for assessing germline or somatic BRCA mutations. The
FDA’s approval of liquid biopsy tests represents a significant
advancement for clinicians and patients to make timely decisions
about treatment options.”
Foundation Medicine expects the FoundationOne Liquid CDx to be
commercially available on Friday, August 28, 2020.
About Prostate Cancer
The American Cancer Society estimates that nearly 192,000 men in
the United States will be diagnosed with prostate cancer in 2020iv,
and the GLOBOCAN Cancer Fact Sheets estimated that approximately
450,000 men in Europe were diagnosed with prostate cancer in 2018.v
Castration-resistant prostate cancer has a high likelihood of
developing metastases. Metastatic castration-resistant prostate
cancer, or mCRPC, is an incurable disease, usually associated with
poor prognosis. Approximately 43,000 men in the U.S. are expected
to be diagnosed with mCRPC in 2020.vi According to the American
Cancer Society, the five-year survival rate for mCRPC is
approximately 30 percent.vii Approximately 12 percent of patients
with mCRPC harbor a deleterious germline and/or somatic mutation in
the genes BRCA1 and BRCA2. These molecular markers may be used to
select patients for treatment with a PARP inhibitor.viii
Rubraca U.S. FDA Approved Indication
Rubraca is indicated for the treatment of adult patients with a
deleterious BRCA mutation (germline and/or somatic)-associated
metastatic castration-resistant prostate cancer (mCRPC) who have
been treated with androgen receptor-directed therapy and a
taxane-based chemotherapy.
This indication is approved under accelerated approval based on
objective response rate and duration of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in confirmatory trials.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has
occurred in patients treated with Rubraca, and are potentially
fatal adverse reactions. In 1146 treated patients, MDS/AML occurred
in 20 patients (1.7%), including those in long term follow-up. Of
these, 8 occurred during treatment or during the 28 day safety
follow-up (0.7%). The duration of Rubraca treatment prior to the
diagnosis of MDS/AML ranged from 1 month to approximately 53
months. The cases were typical of secondary MDS/cancer
therapy-related AML; in all cases, patients had received previous
platinum-containing regimens and/or other DNA damaging agents. In
TRITON2, MDS/AML was not observed in patients with mCRPC (n=209)
regardless of homologous recombination deficiency (HRD)
mutation.
Do not start Rubraca until patients have recovered from
hematological toxicity caused by previous chemotherapy (≤ Grade 1).
Monitor complete blood counts for cytopenia at baseline and monthly
thereafter for clinically significant changes during treatment. For
prolonged hematological toxicities (> 4 weeks), interrupt
Rubraca or reduce dose and monitor blood counts weekly until
recovery. If the levels have not recovered to Grade 1 or less after
4 weeks or if MDS/AML is suspected, refer the patient to a
hematologist for further investigations, including bone marrow
analysis and blood sample for cytogenetics. If MDS/AML is
confirmed, discontinue Rubraca.
Based on findings in genetic toxicity and animal reproduction
studies, advise male patients with female partners of reproductive
potential or who are pregnant to use effective methods of
contraception during treatment and for 3 months following last dose
of Rubraca. Advise male patients not to donate sperm during therapy
and for 3 months following the last dose of Rubraca.
Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were
fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT
elevation (33%), decreased appetite (28%), rash (27%), constipation
(27%), thrombocytopenia (25%), vomiting (22%), and diarrhea
(20%).
Co-administration of rucaparib can increase the systemic
exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may
increase the risk of toxicities of these drugs. Adjust dosage of
CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically
indicated. If co-administration with warfarin (a CYP2C9 substrate)
cannot be avoided, consider increasing frequency of international
normalized ratio (INR) monitoring.
Click here for full
Prescribing Information for Rubraca.
You may also report side effects to Clovis Oncology, Inc. at
1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US
toll-free).
About Accessing Rubraca
Rubraca is available in the United States through specialty
pharmacies and distributors. Clovis is committed to ensuring
Rubraca access for patients and offers eligible patients financial
and reimbursement support through Rubraca Connections. More
information about Rubraca Connections is available at
RubracaConnections.com or by calling 1-844-779-7707 between 8 a.m.
and 8 p.m. Eastern Time, Monday through Friday.
About Rubraca (rucaparib)
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed in multiple tumor types, including
ovarian and metastatic castration-resistant prostate cancers, as
monotherapy, and in combination with other anti-cancer agents.
Exploratory studies in other tumor types are also underway.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer
agents in the U.S., Europe and additional international markets.
Clovis Oncology targets development programs at specific subsets of
cancer populations, and simultaneously develops, with partners, for
those indications that require them, diagnostic tools intended to
direct a compound in development to the population that is most
likely to benefit from its use. Clovis Oncology is headquartered in
Boulder, Colorado, with additional office locations in the U.S. and
Europe. Please visit www.clovisoncology.com for more
information.
About FoundationOne Liquid CDx
FoundationOne Liquid CDx is a qualitative next generation
sequencing based in vitro diagnostic test for prescription use only
that uses targeted high throughput hybridization-based capture
technology to analyze 324 genes utilizing circulating cell-free DNA
(cfDNA) isolated from plasma derived from anti-coagulated
peripheral whole blood of advanced cancer patients. The test is
FDA-approved to report short variants in 311 genes, including
rearrangements and copy number losses in BRCA1 and BRCA2, and is a
companion diagnostic to identify patients who may benefit from
treatment with specific targeted therapies (listed in Table 1 of
the Intended Use) in accordance with the approved therapeutic
product labeling. Additional genomic findings may be reported and
are not prescriptive or conclusive for labeled use of any specific
therapeutic product. Use of the test does not guarantee a patient
will be matched to a treatment. A negative result does not rule out
the presence of an alteration. Patients who are negative for
companion diagnostic mutations should be reflexed to tumor tissue
testing and mutation status confirmed using an FDA-approved tumor
tissue test, if available. For the complete label, including
companion diagnostic indications and complete risk information,
please visit www.F1LCDxLabel.com.
This press release contains forward-looking statements (as
defined under the Private Securities Litigation Reform Act of 1995)
about the potential of Rubraca® (rucaparib) for the treatment of
adult patients with deleterious BRCA mutation (germline and/or
somatic)-associated metastatic castration-resistant prostate cancer
(mCRPC) who have been treated with androgen receptor-directed
therapy and a taxane-based chemotherapy, and reflects Clovis
Oncology’s current beliefs. As with any pharmaceutical product,
there are substantial risks and uncertainties in the process of
development and commercialization that could cause actual results
to differ materially from those expressed or implied by the
forward-looking statements. In particular, there are no guarantees
that future study results and patient experience will be consistent
with the study findings to date, that Rubraca will receive
regulatory approval for any future indications, or that it will
prove to be commercially successful. A further description of risks
and uncertainties can be found in Clovis Oncology’s filings with
the Securities and Exchange Commission, including its Annual Report
on Form 10-K and its reports on Form 10-Q and Form 8-K. All
forward-looking statements are based on information currently
available to the company, and Clovis Oncology does not undertake to
update or revise any forward-looking statements.
Rubraca® is a registered trademark of Clovis Oncology, Inc.
Foundation Medicine® and FoundationOne® are registered
trademarks of Foundation Medicine, Inc.
__________________ i Rubraca [package insert]. Boulder, CO;
Clovis Oncology. 2020. ii Foundation Medicine Inc. news release
dated August 26, 2020. FDA Approves Foundation Medicine's
FoundationOne® Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy
Test with Multiple Companion Diagnostic Indications for Patients
with Advanced Cancer. iii Data on file. Clovis Oncology; Boulder,
CO. iv American Cancer Society. Key Statistics for Prostate Cancer.
https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
Accessed January 30, 2020. v GLOBOCAN Cancer Fact Sheets: prostate
cancer. Prostate Cancer Estimated Incidence, Mortality and
Prevalence Worldwide in 2018.
https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf.
Accessed February 4, 2020. vi Cameron A. Wade and Natasha
Kyprianou. Profiling Prostate Cancer Therapeutic Resistance.
International Journal of Molecular Sciences. 2018, 19, 204.
https://www.mdpi.com/1422-0067/19/3/904/pdf. vii American Cancer
Society. Survival rates for prostate cancer.
https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed February 4, 2020. viii Abida W, Armenia J, Gopalan A, et
al. Prospective Genomic Profiling of Prostate Cancer Across Disease
States Reveals Germline and Somatic Alterations That May Affect
Clinical Decision Making. JCO Precis Oncol 2017: 1-16.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200826005806/en/
Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com Clovis Media Contacts:
U.S. Lisa Guiterman, 301.217.9353 clovismedia@sambrown.com
Europe Jake Davis, +44 (0) 20.3946.3538
Jake.Davis@publicisresolute.com
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