– Using Invitae's Ciitizen patient-driven data
platform, AstraZeneca and the Cholangiocarcinoma Foundation will
access lived experience of patients with a rare cancer to drive
further research –
– Real-world insights will be translated into
cholangiocarcinoma treatment patterns and outcomes in a rapidly
evolving disease landscape –
SAN
FRANCISCO, Oct. 27, 2022 /PRNewswire/ -- Invitae
(NYSE: NVTA), a leading medical genetics company, today announced a
partnership with AstraZeneca (LSE/STO/Nasdaq: AZN) to use Invitae's
Ciitizen natural history data in a retrospective and prospective
study of patients diagnosed with cholangiocarcinoma, a rare bile
duct cancer. This partnership will enable sharing of high-quality,
patient-consented data from the patient community of the
Cholangiocarcinoma Foundation (CCF), a leading patient advocacy
group whose mission is to find a cure and improve the quality of
life for those with cholangiocarcinoma.
"CCF partnered with Invitae to use the Ciitizen data platform in
its earliest days because we saw a need for our patient community
to gain control of their own medical records and drive research
with their own health data," said Stacie
Lindsey, CEO, Cholangiocarcinoma Foundation. "This is a
groundbreaking example of how patient-initiated research and the
quality of data Invitae's Ciitizen platform produces from medical
records can inform real-world questions that will help develop,
improve and expand therapies. We are thrilled that AstraZeneca is
utilizing our data to power their life-changing science. Our
patient community wants their health data to support research that
improves treatment options in this aggressive and rare cancer."
Identifying and recruiting patients with rare diseases into
clinical studies is difficult, making it challenging to understand
the etiology, disease course, differences among subpopulations and
the impact of novel treatments. This partnership is an innovative
approach to solving these challenges by directly engaging the
patient community to incorporate real-world data into AstraZeneca's
research today and in the future.
"We developed the first immunotherapy-based treatment option to
be approved that meaningfully extends long-term survival and has a
manageable safety profile for people with cholangiocarcinoma, but
we're not stopping there," said Camille
Hertzka, vice president and head of U.S. oncology medical
affairs, AstraZeneca. "We're committed to harnessing the power of
CCF and Invitae's Ciitizen data set to more deeply understand
treatment patterns and patient outcomes and continue improving care
for this community of patients."
Patients on AstraZeneca's TOPAZ-1 regime and other treatment
plans will be followed for the next three years, to determine the
long-term efficacy of the currently available treatment options in
hopes that higher-quality drugs can be developed leading to better
patient outcomes. Data collected will include tolerability of the
regimen, autoimmune comorbidities and their impact on outcomes,
sequencing of treatments and observation of real-world usage of
Abraxane added to TOPAZ-1 backbone.
The data used in this partnership, collected on behalf of
patients with cholangiocarcinoma or their caregivers, is
de-identified and shared only with their consent, and represents
the richest aggregation of real-world clinical evidence for
patients with cholangiocarcinoma. The data generated by Invitae's
Ciitizen platform is comprehensive, leveraging the HIPAA right of
access to gather full medical records, longitudinally, from all of
the patients' sites of care. This approach addresses many of the
limitations of other data sources, such as provider electronic
medical record and claims data, that were raised by the FDA in
recent draft guidance documents on the use of real-world data in
regulatory submissions. Patients have complete access to the
records for their own use and are also able to remain involved and
informed about the research throughout the study, highlighting the
benefits of this unique patient-centered research model.
"We are thankful to the Cholangiocarcinoma Foundation and its
patients for trusting us with their health data and to AstraZeneca
for seeing the potential of this data to inform their scientific
endeavors," said Farid Vij, general
manager of patient network and data at Invitae. "With this
investment from AstraZeneca, our Cholangiocarcinoma Foundation
patients are joining the research data ecosystem and seeing their
data used to advance cures for this community, something our
patients have always believed in. This reflects our core ethos,
that data belongs to the patient and is more powerful when shared,
and also demonstrates that we can generate data at a level of
quality that can inform key insights and decisions for both
AstraZeneca and cholangiocarcinoma patients. We can't wait to see
what important disease and treatment insights AstraZeneca learns
from this meaningful cohort."
Invitae's Ciitizen platform enables the rapid and comprehensive
collection and analysis of medical history data, which supports
understanding of the patient population and disease severity,
informs an understanding of real-world treatment patterns and
outcomes in this rare cancer to advance knowledge of the disease
and helps identify potential drug development needs.
Join a live webinar on Wednesday,
November 2 at 10 a.m. PT with
speakers from AstraZeneca, the Cholangiocarcinoma Foundation and
Invitae to learn how they are working together to improve care for
patients with cholangiocarcinoma. Click here to register.
About Invitae
Invitae Corporation (NYSE: NVTA) is a
leading medical genetics company, whose mission is to bring
comprehensive genetic information into mainstream medicine to
improve healthcare for billions of people. Invitae's goal is to
aggregate the world's genetic tests into a single service with
higher quality, faster turnaround time and lower prices. For more
information, visit the company's website at invitae.com.
Safe Harbor Statement
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
relating to the company's belief that this collaboration
demonstrates that the company can generate data at a level of
quality that can inform key insights and decisions for partners and
patients; and the benefits of the data generated through the
company's Ciitizen platform. Forward-looking statements are subject
to risks and uncertainties that could cause actual results to
differ materially, and reported results should not be considered as
an indication of future performance. These risks and uncertainties
include, but are not limited to: the company's history of losses;
the company's ability to compete; the company's failure to manage
growth effectively; the company's need to scale its infrastructure
in advance of demand for its tests and to increase demand for its
tests; the company's ability to use rapidly changing genetic data
to interpret test results accurately and consistently; security
breaches, loss of data and other disruptions; laws and regulations
applicable to the company's business; and the other risks set forth
in the company's filings with the Securities and Exchange
Commission, including the risks set forth in the company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2022. These forward-looking statements
speak only as of the date hereof, and Invitae Corporation disclaims
any obligation to update these forward-looking statements.
Invitae PR contact:
Amanda McQuery
pr@invitae.com
(628) 213-3283
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SOURCE Invitae Corporation