Invitae partners with AstraZeneca

– 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 –

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.

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