On May 29, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported that new data generated from its comprehensive genomic profiling (CGP) assays will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 1-5, 2018 in Chicago (Press release, Foundation Medicine, MAY 29, 2018, View Source [SID1234526928]). The company and its collaborators will present a total of 28 studies, including two oral presentations. Highlights of these presentations include:
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studies demonstrating the importance of known and novel genomic biomarkers of immunotherapy response, including tumor mutational burden (TMB), microsatellite instability (MSI) and PBRM1 alterations across a diverse range of cancer types that could inform more precise use of these treatments;
new data from PURE-01, a phase II study evaluating neo-adjuvant pembrolizumab in urothelial bladder cancer demonstrates the ability of CGP to detect genomic biomarkers (RB1, PBRM1 and TMB) when combined with T-cell inflammation signatures to potentially predict response to immunotherapy;
new data showing that high tissue TMB is associated with higher likelihood of response and longer duration of response to atezolizumab in non-small cell lung cancer, metastatic urothelial carcinoma and melanoma;
data from FoundationACT liquid biopsy assay, describing the landscape of kinase fusions and rearrangements from ctDNA in more than 9,000 clinical cases across multiple cancer types; and
updated data from the precision oncology I-PREDICT clinical trial showing improvements in patient outcomes with integration of molecular tumor boards informed by CGP into treatment planning.
These studies further underscore the importance of Foundation Medicine’s portfolio of CGP assays and molecular data services in supporting precision treatment approaches using tissue or blood samples.
"The role of comprehensive genomic profiling in cancer treatment is evolving very quickly, particularly in predicting who will respond best to new treatments, such as immunotherapy. Foundation Medicine has led essential discoveries in advancing TMB and other genomic biomarkers of immunotherapy response that will help shape the treatment landscape and advance our understanding of how best to use personalized immunotherapy treatment in clinical care," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "Our studies presented at ASCO (Free ASCO Whitepaper) underscore our patient-centric approach using CGP to further refine the clinical utility of existing biomarkers while discovering new ones that can help better inform precision treatments across a broad range of cancer types with the ultimate goal of improving patient care."
Comprehensive genomic profiling is helping to uncover the predictive power of TMB and other pathogenic biomarkers in different types of cancer. In data to be presented in an oral session, biomarker analysis by CGP in metastatic urothelial carcinoma has the potential to identify patients who could benefit from a bladder sparing approach through the opportunity to respond to immune checkpoint inhibitors.
"The near 40% frequency of complete pathologic response to the neoadjuvant pembrolizumab regimen in this bladder muscle invasive urothelial carcinoma trial is unprecedented. These results substantially improved by selecting patients harboring molecular alterations, regardless of PD-L1 expression," said Andrea Necchi, M.D., department of medical oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. "Our data indicate that biomarker-based patient selection using the comprehensive genomic profiling and gene expression profiling has the potential to identify patients destined to achieve complete tumor eradication and raises the possibility that this sub-group of patients could be managed in the future without radical cystectomy."
In another oral presentation, a pooled analysis of seven clinical studies of the anti-PD-L1 immunotherapy agent atezolizumab found that high TMB was associated with improved response and duration of response in non-small cell lung cancer, metastatic urothelial carcinoma and melanoma. Additionally, in a separate presentation, investigators from the Moffitt Cancer Center worked with Foundation Medicine scientists utilizing CGP to show that within a group of 57 advanced Merkel cell carcinoma (MCC) patients, nearly all had either high TMB or evidence of the Merkel cell polyomavirus as measured by viral content detection. Patients with neither marker were unlikely to respond to immunotherapy, which may help guide use of this treatment in MCC in which high response rates to immunotherapy have been observed but predictive factors of response have not been well elucidated.
New studies also characterize the landscape of PBRM1 alterations, a new potential biomarker of immunotherapy response. Recent evidence suggests that PBRM1 alterations are associated with clinical benefit from checkpoint inhibitor immunotherapy in clear cell renal carcinoma (ccRCC), an immunotherapy-responsive tumor type which characteristically lack high MSI or TMB. In a new study presented at ASCO (Free ASCO Whitepaper), CGP was performed on more than 140,000 solid tumors and hematologic malignancies and found that PBRM1 alterations were highly enriched in ccRCC (45 percent) compared with other tumor types (2.6 percent). Another study of mesothelioma found that PBRM1 alterations were present in 11 percent of samples, suggesting that immunotherapy may also serve as an important treatment option in this cancer type.
Because a tissue sample may not be readily available for some cancer patients, especially those with advanced disease, liquid biopsy is becoming an increasingly important option to help inform personalized treatment approaches. In new data presented, FoundationACT was used to help describe the pan-cancer landscape of kinase rearrangements, which are established therapeutic targets. Analysis of circulating tumor DNA (ctDNA) from blood samples of nearly 9,000 clinical cases showed that kinase fusions and rearrangements exist across tumor types and can be detected using FoundationACT, which may help inform both treatment decisions and clinical development.