Foundation Medicine, Inc. (NASDAQ:FMI) today announced that new
data generated from its comprehensive genomic profiling (CGP)
assays will be presented at the American Society of Clinical
Oncology (ASCO) Annual Meeting from June 1-5, 2018 in Chicago. The
company and its collaborators will present a total of 28 studies,
including two oral presentations. Highlights of these presentations
include:
- 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 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, 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.
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 Foundation MedicineFoundation Medicine (NASDAQ:FMI)
is a molecular information company dedicated to a transformation in
cancer care in which treatment is informed by a deep understanding
of the genomic changes that contribute to each patient's unique
cancer. The company offers a full suite of comprehensive genomic
profiling assays to identify the molecular alterations in a
patient's cancer and match them with relevant targeted therapies,
immunotherapies and clinical trials. Foundation Medicine’s
molecular information platform aims to improve day-to-day care for
patients by serving the needs of clinicians, academic researchers
and drug developers to help advance the science of molecular
medicine in cancer. For more information, please visit
http://www.FoundationMedicine.com or follow Foundation Medicine on
Twitter (@FoundationATCG).
Cautionary Note Regarding Forward-Looking Statements for
Foundation MedicineThis 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; Foundation Medicine's assays and molecular
information platform will not be able to identify genomic
alterations in the same manner as prior clinical data; and the
risks described under the caption "Risk Factors" in Foundation
Medicine's Annual Report on Form 10-K for the year ended December
31, 2017, which is on file with the Securities and Exchange
Commission, as well as other risks detailed in Foundation
Medicine's subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and Foundation Medicine undertakes no duty to
update this information unless required by law.
Foundation Medicine® and FoundationACT® are registered
trademarks of Foundation Medicine, Inc.
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Foundation MedicineMedia:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestors:Kimberly
Brown, 617-418-2215ir@foundationmedicine.com
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