Foundation Medicine and Collaborators to Present New Data at ASCO 2018 Supporting Comprehensive Genomic Profiling (CGP) to Inform Personalized Approaches in Cancer Care
- 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.
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
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
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
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.
Following is a list of abstracts that will be presented at the meeting.
Abstract # | Title | Day/Time | Location | ||||||
Immunotherapy/TMB Data | |||||||||
4507 (Oral Presentation) | Preoperative pembrolizumab (pembro) before radical cystectomy (RC) for muscle-invasive urothelial bladder carcinoma (MIUC): Interim clinical and biomarker findings from the phase 2 PURE-01 study. | June 3, 10:12am-10:25am | Arie Crown Theater | ||||||
12000 (Oral Presentation) | Association of high tissue TMB and atezolizumab efficacy across multiple tumor types | June 5, 8:00am-8:12am | Room S406 | ||||||
11553 | Primary pulmonary sarcomas (PSRC): A comprehensive genomic profiling (CGP) study | June 2, 8:00am-11:30am | Hall A | ||||||
11576 | Genomic subtypes of angiosarcoma: a comprehensive genomic profiling (CGP) study | June 2, 8:00am-11:30am | Hall A | ||||||
4547 | APACHE: An open label, randomized, phase 2 study of Durvalumab (Durva), alone or in combination with Tremelimumab (Treme), in patients (pts) with advanced germ cell tumors (GCT): results at the end of first stage | June 2, 8:00am-11:30am | Hall A | ||||||
4531 | FGFR3 driven metastatic urothelial carcinoma of the urinary bladder (mUCB): A comprehensive genomic profiling study | June 2, 8:00am-11:30am | Hall A | ||||||
4595 | PECULIAR: An open label, multicenter, single-arm, phase 2 study of neoadjuvant pembrolizumab (PEM) and epacadostat (EPA), preceding radical cystectomy (Cy), for patients (pts) with muscle-invasive urothelial bladder cancer (MIUBC). | June 2, 8:00am-11:30am | Hall A | ||||||
4536 | Prognostic values of genetic alterations of DNA repair genes in advanced bladder cancer. | June 2, 8:00am-11:30am | Hall A | ||||||
11579 | Frequency of genomic biomarkers of response to immunotherapy in sarcoma | June 2, 8:00am-11:30am | Hall A | ||||||
3574 | MSI-high and MSI-stable colorectal carcinomas (CRC): A comprehensive genomic profiling (CGP) Study | June 3, 8:00am-11:30am | Hall A | ||||||
8562 | PBRM1 genomic alterations in mesothelioma: potential predictor of immunotherapy efficacy | June 3, 8:00am-11:30am | Hall A | ||||||
12091 | PBRM1 mutation and immunotherapy efficacy: A comprehensive genomic profiling (CGP) assessment | June 4, 1:15pm-4:45pm | Hall A | ||||||
12092 | PD-L1 genomic alterations (GA) in solid tumors and hematologic malignancies: A comprehensive genomic profiling (CGP) study | June 4, 1:15pm-4:45pm | Hall A | ||||||
9587 | Comprehensive genomic profiling of metastatic cutaneous adnexal carcinomas to reveal multiple routes to targeted and immunotherapies | June 4, 1:15pm-4:45pm | Hall A | ||||||
Targeted Therapy Data | |||||||||
5521 (Poster Discussion) | Genomic mutation profiles of paired ovarian cancers (OC) across time | June 4, 4:45pm-6:00pm | Room S100bc | ||||||
1074 | Efficacy of olaparib monotherapy in patients (pts) with HER2-negative metastatic breast cancer (MBC) with germline BRCA mutation (gBRCAm) or lesional BRCA mutation (lBRCAm) | June 2, 8:00am-11:30am | Hall A | ||||||
4555 | Comprehensive genomic characterization of chemotherapy-resistant testicular germ cell tumors (TGCT) | June 2, 8:00am-11:30am | Hall A | ||||||
6089 | Comprehensive genomic profiling of anaplastic thyroid carcinoma | June 2, 1:15pm-4:45pm | Hall A | ||||||
2039 | Comprehensive genomic profiling of brain tumors provides targeted therapy options and diagnostic certainty for oligodendrogliomas | June 2, 1:15pm-4:45pm | Hall A | ||||||
4063 | Co-existing alterations in cell-cycle pathway genes and impact on benefit from trastuzumab in advanced esophagogastric cancers (EGC): Analysis of 527 Her2-amplified cases | June 3, 8:00am-11:30am | Hall A | ||||||
9035 | Multi-kinase RET inhibitor vandetanib combined with mTOR inhibitor everolimus in patients with RET rearranged non-small cell lung cancer | June 3, 8:00am-11:30am | Hall A | ||||||
2531 | Investigation of Profile-Related Evidence Determining Individualized Cancer Therapy (I-PREDICT) in heavily pre-treated patients: A role for combinatorial precision cancer therapy | June 4, 8:00am-11:30am | Hall A | ||||||
12083 | Clinicopathologic characteristics and molecular features of BRG1-deficient non-small cell lung cancer (NSCLC) | June 4, 1:15pm-4:45pm | Hall A | ||||||
5590 | Assessment of activating estrogen receptor 1 (ESR1) mutations in gynecologic malignancies | June 4, 1:15-4:45pm | Hall A | ||||||
Liquid Biopsy Data | |||||||||
9040 | Characterization of 1,233 NSCLCs with non-del19/L858R EGFR mutations (EGFRm) using comprehensive genomic profiling (CGP) | June 3, 8:00am-11:30am | Hall A | ||||||
12041 | Landscape of kinase rearrangements (kRE) detected in circulating tumor DNA (ctDNA) | June 4, 1:15pm-4:45pm | Hall A |
About
Cautionary Note Regarding Forward-Looking Statements for
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the value and impact of CGP, including Foundation Medicine’s suite of CGP assays, and molecular information from CGP; the ability of TMB, MSI, PBRM1, or any other biomarkers to predict response to immunotherapy; and the ability of research and discovery of biomarkers to improve access to personalized cancer treatment. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risk that the results presented are found to lack scientific, medical or clinical utility or that subsequent research renders the results presented less useful or not useful in clinical practice;
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