- Detailed results of the Phase 2 FIGHT trial have been accepted
for late breaker presentation during the Esophageal and Gastric
cancer oral abstract session on January 15, 2021
- Company to host webcast and conference call on January 15 at
1:30pm PST / 4:30pm EST
Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage
biotechnology company focused on developing immune modulators and
precision therapies for solid tumor cancers, today announced that
detailed results from the global, randomized, double-blind
placebo-controlled Phase 2 FIGHT trial evaluating bemarituzumab
plus mFOLFOX6 chemotherapy in patients with fibroblast growth
factor receptor 2b-positive (FGFR2b+), non HER2 positive (non
HER2+) advanced gastric and gastroesophageal junction (GEJ) cancer
will be featured during an oral podium presentation on January 15,
2021, at the ASCO Gastrointestinal Cancers Symposium being held
virtually from January 15-17, 2021.
On November 10, 2020, Five Prime announced that the FIGHT trial
met all three efficacy endpoints with bemarituzumab in combination
with mFOLFOX6 chemotherapy providing statistically significant and
clinically meaningful improvements in progression-free survival,
overall survival, and objective response rate compared with
mFOLFOX6 chemotherapy plus placebo in the front-line setting of
patients with FGFR2b+, non HER2+ advanced gastric or GEJ
cancer.
Bemarituzumab is the first and only investigational treatment
targeting FGFR2b+ tumors. FGFR2b is overexpressed in approximately
30 percent of non HER2+ gastric and GEJ cancers. For these
patients, no new front-line therapies have been approved in over a
decade and systemic chemotherapy remains the standard of care. Five
Prime and Roche Tissue Diagnostics (formerly Ventana Medical
Systems) have also found that FGFR2b is overexpressed in numerous
other cancers, including squamous non-small cell lung cancer,
triple negative breast cancer, ovarian cancer, pancreatic cancer
and intrahepatic cholangiocarcinoma. This represents additional
potential areas for development of bemarituzumab beyond gastric and
GEJ cancer.
The Company will host a conference call and live audio webcast
on Friday, January 15, 2021 at 4:30pm (EST) / 1:30pm (PST) to
review highlights from the presentation and will feature members of
the Five Prime management team and Zev A. Wainberg, M.D., Associate
Professor of Medicine at UCLA, Co-director of the Gastrointestinal
Oncology Program and Director of Early Phase Clinical Research at
the Jonsson Comprehensive Cancer Center, and a principal
investigator of the trial.
Oral Presentation Details:
- Title: Randomized Double-blind Placebo-Controlled Phase
2 Study of Bemarituzumab Combined with Modified FOLFOX6 (mFOLFOX6)
in 1st Line (1L) Treatment of Advanced Gastric/Gastroesophageal
Junction Adenocarcinoma (FIGHT)
- Abstract Number: 160
- Oral Abstract Session: Esophageal and Gastric
Cancer
- Day and Time: Friday, January 15, 2021, 7:00am – 8:15am
PST / 10:00am 11:15am EST
- Author and Q&A Presenter: Zev A. Wainberg, M.D.,
Associate Professor of Medicine at UCLA, Co-director of the
Gastrointestinal Oncology Program and Director of Early Phase
Clinical Research at the Jonsson Comprehensive Cancer Center
Conference Call Information
Five Prime will host a conference call and live audio webcast on
Friday, January 15, 2021 at 4:30pm EST / 1:30pm PST to discuss the
detailed Phase 2 FIGHT trial results presented at ASCO GI. To
participate in the conference call, please dial (877) 878-2269
(domestic) or (253) 237-1188 (international) and refer to
conference ID: 2063209. To access the live webcast please visit
https://investor.fiveprime.com/events-presentations.
An archived copy of the webcast will be available on Five
Prime's website beginning approximately two hours after the
conference call. Five Prime will maintain an archived replay of the
webcast on its website for at least 30 days after the conference
call.
About the FIGHT Trial
The FGFR2b Inhibition in Gastric and
Gastroesophageal Junction Cancer Treatment (FIGHT)
trial (NCT03694522) was designed to evaluate the efficacy and
safety of bemarituzumab in combination with modified FOLFOX6
(mFOLFOX6; leucovorin calcium, fluorouracil, and oxaliplatin) vs.
mFOLFOX6 plus placebo in the front-line setting of patients with
newly diagnosed FGFR2b positive, locally advanced or metastatic
gastric and GEJ cancer.
Patients’ tumors were identified to be FGFR2b+ by
immunohistochemistry and by FGFR2 gene amplification using a
blood-based circulating tumor DNA assay. Testing was performed at a
central laboratory.
The trial enrolled 155 patients in 15 countries across Asia, the
European Union, and the United States.
About FGFR2b
The fibroblast growth factor (FGF)/fibroblast growth factor
receptor (FGFR) pathway is implicated in the development and growth
of cancer cells. FGFR2b is a form of FGFR found in epithelial
cells, such as those in the stomach and skin. Data from the FIGHT
trial suggests that approximately 30% of patients with non HER2+
gastroesophageal cancers overexpress FGFR2b.1 Five Prime and Roche
Tissue Diagnostics have also found that FGFR2b is overexpressed in
numerous other cancers, including squamous non-small cell lung
cancer (NSCLC), triple negative breast (TNBC), ovarian, pancreatic
and intrahepatic cholangiocarcinoma.
About Bemarituzumab
Bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted
antibody that blocks fibroblast growth factors (FGFs) from binding
and activating FGFR2b, inhibiting several downstream pathways.
Blocking FGFR2b activation is thought to slow cancer progression.
Bemarituzumab is being developed in gastric and GEJ cancer as a
targeted therapy for tumors that overexpress FGFR2b.
Five Prime granted an exclusive license to Zai Lab to develop
and commercialize bemarituzumab in Greater China, and Zai Lab
collaborated with Five Prime on the Phase 2 FIGHT trial in Greater
China.
About Gastric Cancer and GEJ Cancer
Gastric cancer, also known as stomach cancer, is the third most
common cause of cancer death worldwide and, excluding non-melanoma
skin cancer, the fifth most common cancer worldwide, with over
1,000,000 new cases diagnosed each year.2 For HER2- patients,
front-line therapy available today is the same systemic
chemotherapy available since the 1990s.3,4
About Five Prime Therapeutics
Five Prime is a clinical stage biotechnology company
relentlessly focused on rewriting the narrative for people with
cancer. By tackling the tough scientific questions and untapped
pathways, we aim to offer new hope by developing novel,
breakthrough therapies that have potential to alter the course of
disease in cancers with few treatment options. This vision is what
defines us, and guides our research, clinical development and
partnerships. To build a better tomorrow for people with cancer, we
are teaming up with patients, physicians, scientists, and industry
partners to make a meaningful difference in patients’ lives. Five
Prime collaborates with leading global pharmaceutical companies and
has therapies in pre-clinical and clinical development. For more
information, please visit www.fiveprime.com.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend" and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Five Prime's
expectations and assumptions as of the date of this press release.
Each of these forward-looking statements involves risks and
uncertainties. Forward-looking statements contained in this press
release include statements regarding (i) the potential advancement
of the development of bemarituzumab; (ii) the potential use of
bemarituzumab, including in combination with other products, to
treat patients; (iii) the potential development of bemarituzumab in
indications in addition to gastric and GEJ cancer; (iv) the timing
of the presentation of data for bemarituzumab; and (v) the extent
of FGFR2b protein overexpression in certain patient populations.
Actual results may differ materially from these forward-looking
statements. Many factors may cause differences between current
expectations and actual results, including unexpected safety or
efficacy data observed during research, preclinical or clinical
studies, changes in expected or existing competition, changes in
the regulatory, pricing or reimbursement environment, and
unexpected litigation or other disputes. In addition, while the
company expects the COVID-19 pandemic to adversely affect its
business operations and financial results, the extent of the impact
on the company’s ability to advance its preclinical development and
business and corporate development and other objectives will depend
on future developments that are highly uncertain, and the company
cannot predict with confidence the ultimate duration of the
pandemic, travel restrictions, quarantines, social distancing and
business closure requirements in the U.S. and in other countries
and the effectiveness of actions taken globally to contain and
treat COVID-19. Other factors that may cause actual results to
differ from those expressed or implied in the forward-looking
statements in this press release are discussed in Five Prime’s
filings with the U.S. Securities and Exchange Commission, including
the “Risk Factors” contained therein. Except as required by law,
Five Prime assumes no obligation to update any forward-looking
statements contained herein to reflect any change in expectations,
even as new information becomes available.
References
1. Data on file. Five Prime Therapeutics; 2020.
2. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer
statistics 2018: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA Cancer J Clin.
2018;68(6):394-424. doi:10.3322/caac.21492
3. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for
advanced gastric cancer. Cochrane Database Syst Rev.
2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub4
4. Drugs approved for stomach (gastric) cancer. Food and Drug
Administration. Updated April 21, 2020. Accessed October 14, 2020.
https://www.cancer.gov/about-cancer/treatment/drugs/stomach#1
Source: Five Prime Therapeutics, Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201209006002/en/
Media and Investor Contact Martin Forrest VP, Investor
Relations & Corporate Communications Five Prime Therapeutics,
Inc. 415-365-5625 martin.forrest@fiveprime.com
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