Precision medicine requires an end-to-end learning health care system, wherein the treatment decisions for patients are powered by the prior experiences of every similar patient who has preceded them. Oncology is currently leading the way in precision medicine because the factors that fuel cancer initiation, progression, and recurrence—namely, the genomic and other molecular characteristics of patients and their tumors—are routinely collected at scale. A major challenge to this approach, however, is that no single institution is able to sequence and treat sufficient numbers of patients to improve clinical decision-making independently. The AACR Project GENIE® (Genomics Evidence Neoplasia Information Exchange) registry was established in 2015 to address this challenge and realize the promise of precision medicine.
AACR Project GENIE® is an open-source, international, pancancer registry of real-world data assembled through data sharing between 19 leading international cancer centers. The registry leverages ongoing clinical sequencing efforts at participating cancer centers by pooling their data to serve as an evidence base for the entire cancer community. The consortium and its activities are driven by openness, transparency, and inclusion to ensure that the project output remains accessible to the global cancer research community and ultimately benefits patients.
In 2021—its sixth year of operation—AACR Project GENIE® made further progress in harnessing the power of precision medicine for the benefit of patients with cancer:
- GENIE shared its ninth and tenth public data releases in January and July, respectively, which increased the size of the registry to more than 111,000 patients. Following these releases, genomic and baseline clinical data from nearly 121,000 tumors are accessible through the efforts of the project’s strategic and technical partners, Sage Bionetworks and cBioPortal.
- In April, the registry held its second minisymposium during the virtual AACR Annual Meeting. A total of 12 abstracts featuring data from Project GENIE had been received for presentation at the AACR Annual Meeting 2020. That number nearly doubled in 2021, as a total of 23 abstracts featuring GENIE data were presented at the meeting. The highest-rated of these abstracts were showcased in the minisymposium, which was titled “Advancing Cancer Research Through an International Cancer Registry: AACR Project GENIE Use Cases.”
- The project marked a critical milestone in May, when data from the GENIE registry were included as part of a successful regulatory submission to the FDA that led to the approval of sotorasib for the treatment of KRAS G12C‑mutated locally advanced or metastatic non–small cell lung cancer. A detailed analysis of these KRAS data will be published in 2022.
- As 2021 came to a close, nearly 10,000 individuals had registered to use Project GENIE data, and more than 500 papers had cited the data set.
- The Biopharma Collaborative (BPC)—a five-year, $36 million research collaboration between AACR Project GENIE® and a coalition of nine biopharmaceutical companies that launched in 2019 to expand the scope and accelerate the speed of clinical data collection at participating institutions—yielded exciting results in 2021. By the end of the year, detailed clinical data from a combined 7,500 cases of non–small cell lung, colorectal, breast, pancreatic, prostate, and bladder cancers were completed. The BPC is working toward the public release of these data in early 2022.
(Data through December 2021)
10
Public data releases have been made since the project launched in November 2015.
18
Institutions from six countries participate in the project. AACR Project GENIE® Participating Institutions include many of the world’s vanguard academic centers with expertise in genomics, molecular pathology, cancer biology, clinical trial design/execution, and medical informatics.
120,953
Samples are sequenced in the registry.*
111,222
Patients have tumors sequenced in AACR Project GENIE®, making it one of largest fully public cancer genomic data sets released to date.*
7,327
Pediatric patients (18 or younger at time of sequencing) are included in the data set.*
9,069
Young adult patients (between 18 and 39 years of age at time of sequencing) are included in the data set.*
14,672
Non-white patients are included in the data set.*
109
Major cancer types are included in the registry.
742
Unique cancer types from 109 major cancer types are included in the registry.*
*10.0 public release, July 2021
