New Data Confirm Clinical Benefit of Project GENIE

Approximately one-third of all cancers may have an actionable genetic mutation, according to the first objective measure of actionability across a large cohort of patients representing a full spectrum of cancers. 

An analysis from Project Genomics Evidence Neoplasia Information Exchange (GENIE) presented at the American Association for Cancer Research (AACR) Annual Meeting 2017, held April 1–5 in Washington, DC, is documenting the clinical benefit of genotype-driven therapies and immunotherapies in a new way.

AACR Project GENIE is a multiphase, multiyear, international data-sharing project that catalyzes precision oncology through the development of a regulatory-grade registry. The registry aggregates and links clinical-grade cancer genomic data with clinical outcomes from tens of thousands of cancer patients treated at multiple international institutions.

“AACR Project GENIE is the first public release of genomic and clinical data from a large number of patients, approximately 19,000, sequenced at cancer centers who are undergoing treatment. It is already a useful database for queries about rare mutations, for planning clinical trials with genomic enrollment criteria, and for the frequency of mutations in metastatic disease compared to primary disease,” AACR Past President and Project GENIE Steering Committee Chairperson Charles Sawyers, MD, told OncoTherapy Network. 

Sawyers and his colleagues contend that this project is warranted in order to fulfill an unmet need in oncology. Project GENIE can provide the statistical power necessary to identify novel therapeutic targets and to understand genomic determinants of response to therapy. It is hoped this ongoing project also will lead to better designed biomarker-driven clinical trials.

“A first pass analysis suggests that > 30% of the patients in the AACR Project GENIE database have findings from the sequencing test that are considered actionable, meaning that the oncologist might recommend a different treatment or participation in a clinical trial based on the result,” said Sawyers.

The analysis takes into account the combine clinical actionability assertions from My Cancer Genome (Vanderbilt-Ingram Cancer Center), Personalized Cancer Therapy (MD Anderson Cancer Center), and OncoKB (Memorial Sloan Kettering Cancer Center). The team gathered data on GENIE patient genotypes and clinical actionability assertions from these institutes.

The researchers found that > 33% of patient samples not only matched at least one therapeutic assertion, but also approximately 15% matched at the standard-of-care level, and approximately 8% matched at the level of investigational therapies. Most frequently matching diagnoses at the standard-of-care level were non-small cell lung cancer, breast cancer, and melanoma.

The authors hope that the GENIE project will result in much bigger than sharing data. This collaborative effort between institutions will not only reconcile but also improve precision cancer medicine. Sawyers said the database is expected to grow to 100,000 patients in just the next several years.

“As the database grows and longitudinal outcome data are collected, the AACR Project GENIE should become a valuable cancer registry for documenting clinical benefit of genotype-driven therapies and immunotherapies,” said Sawyers.