Market Overview

Foundation Medicine and Collaborators to Present New Data at ASCO 2018 Supporting Comprehensive Genomic Profiling (CGP) to Inform Personalized Approaches in Cancer Care


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
  • 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
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
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