Median overall survival was 6.6 months and consistent across
subgroups including refractory status, stage of disease and line of
Overall response rate was 26% with only 8% achieving a complete
Data provide a benchmark for future studies
Kite Pharma, Inc. (Nasdaq:KITE) ("Kite") today announced results from
Research), the first, large, systematic,
multi-institutional, patient-level meta-analysis of outcomes from 635
patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). The
study showed that patients with chemorefractory disease - defined as
disease that does not respond to treatment with a chemotherapy-based
regimen or has relapsed less than 12 months after autologous stem cell
transplant (ASCT) - have consistently poor outcomes regardless of
refractory subgroup, line of therapy, and disease stage. The study will
be presented today at the 2016 American Society of Clinical Oncology
(ASCO) Annual Meeting (abstract #7516).
"These study results are important because they confirm the regrettable
outcomes that have been observed in the clinical setting for people with
this difficult-to-treat form of DLBCL," said Dr. John Kuruvilla,
Associate Professor of Medicine at the University of Toronto, and a
clinical investigator in the Department of Medical Oncology at Princess
Margaret Cancer Centre in Toronto. "While DLBCL is considered curable
with initial chemotherapy-based treatment, patients with chemorefractory
DLBCL have limited-to-no treatment options and historically poor
outcomes, underscoring the significant need for new therapies."
According to the American Cancer Society, non-Hodgkin lymphoma (NHL)
accounts for about four percent of all cancers in the United States,
making it one of the most common cancers diagnosed. DLBCL is the most
common form of the disease, accounting for one out of every three cases
of NHL.1 It is estimated that approximately 26,000 people
will be diagnosed with DLBCL in the United States in 2016.
"Little is known about the outcomes of people with chemorefractory
DLBCL, leaving a large gap in the treatment landscape. These data help
to track the course of the disease and provide an important historical
benchmark for studies in this patient population," said David Chang,
M.D., Ph.D., Kite's Executive Vice President, Research and Development,
and Chief Medical Officer. "We are proud to partner with clinicians,
scientists and researchers at MD Anderson Cancer Center, the Mayo
Clinic, the University of Iowa, the Canadian Cancer Trials Group, and
LYSARC (The Lymphoma Academic Research Organisation) to help establish a
better understanding of the disease to determine how best to treat
patients with chemorefractory DLBCL."
About the SCHOLAR-1 Study
The SCHOLAR-1 (Retrospective
Research) is a retrospective analysis of
patients with chemorefractory DLBCL comprised of data from Phase 3
studies from the Canadian Cancer Trials Group (CCTG LY.12 Study) and
LYSARC (CORAL Study) and large retrospective databases including from
the MD Anderson Cancer Center, Mayo Clinic and University of Iowa
Specialized Programs of Research Excellence (SPORE).
In the study, 635 patients with chemorefractory DLBCL were eligible for
evaluation based on the following criteria: DLBCL defined as progressive
disease as best response to chemotherapy; or stable disease as best
response to chemotherapy (received at least 4 cycles of first-line or 2
cycles of later-line therapy); or relapse ≤ 12 months of ASCT. Patients
must have received an anti-CD20 monoclonal antibody (unless CD20
negative) and an anthracycline as one of their prior regimens.
Results to be presented at ASCO showed:
The overall response rate (ORR; complete response plus partial
response) across all 635 patients was 26% (165/635) with only 8%
(51/635) achieving a complete response, showing no signs of the disease
The response rates were consistent ranging from 21% to 31% ORR and 2%
to 15% complete response (CR) across centers and data sets
Median overall survival was 6.6 months and consistent across subgroups
including refractory status, stage of disease and line of therapy
About Kite Pharma
Kite Pharma, Inc. is a clinical-stage biopharmaceutical company engaged
in the development of novel cancer immunotherapy products, with a
primary focus on engineered autologous cell therapy (eACT™) designed to
restore the immune system's ability to recognize and eradicate tumors.
Kite is based in Santa Monica, CA. For more information on Kite Pharma,
please visit www.kitepharma.com.
Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. We may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could," "might,"
"will," "should" or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the ability to advance therapies for the
treatment of chemorefractory DLBCL. Various factors may cause
differences between Kite's expectations and actual results as discussed
in greater detail in Kite's filings with the Securities and Exchange
Commission, including without limitation in its Form 10-Q filed with
the SEC on May 9, 2016. Any forward-looking statements that we make in
this press release speak only as of the date of this press release. We
assume no obligation to update our forward-looking statements whether as
a result of new information, future events or otherwise, after the date
of this press release.
1. American Cancer Society. Non-Hodgkin Lymphoma. http://www.cancer.org/acs/groups/cid/documents/webcontent/003126-pdf.pdf
Accessed May 20, 2016
View source version on businesswire.com: http://www.businesswire.com/news/home/20160606005530/en/
Kite Pharma, Inc.
VP, Investor Relations
Source: Kite Pharma, Inc.
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