- All three efficacy endpoints (PFS, OS and ORR) in the FIGHT
Phase 2 trial met pre-specified statistical significance
- 2021 priorities for the bemarituzumab program include
collaborating with regulatory agencies on next steps, initiating a
global Phase 3 trial in gastric and GEJ cancers and evaluating
bemarituzumab in other epithelial cancers that overexpress
FGFR2b
- Results presented today in a late-breaking oral presentation at
the 2021 American Society of Clinical Oncology (ASCO)
Gastrointestinal Cancers Virtual Annual Symposium
- Five Prime to host webcast and conference call today at 1:30pm
PST / 4:30pm EST
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) today announced
clinical results from the global, randomized, double-blind
placebo-controlled Phase 2 FIGHT trial evaluating first-in-class
targeted therapy bemarituzumab in advanced gastric or
gastroesophageal junction (GEJ) cancer. Trial results were
presented in a late-breaking oral presentation today by UCLA
Health’s Zev Wainberg, M.D., at the 2021 ASCO Gastrointestinal
Cancers Virtual Annual Symposium (ASCO GI). The ASCO GI
presentation slides are available on the company’s website.
The FIGHT trial evaluated bemarituzumab plus chemotherapy
(mFOLFOX6) versus placebo plus chemotherapy in patients with
fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2
positive frontline advanced gastric or GEJ cancer. The trial
enrolled 155 patients in 15 countries across Asia, the European
Union, and the United States, with 77 patients randomized to the
bemarituzumab arm and 78 patients to the placebo arm.
The Phase 2 trial met all three efficacy endpoints and
demonstrated statistically significant and clinically meaningful
improvements in the primary endpoint of progression-free survival
(PFS) and secondary endpoints of overall survival (OS) and overall
response rate (ORR). Additional analysis showed a positive
correlation between benefit and the percentage of FGFR2b+ tumor
cells, confirming both the importance of the FGFR2b target and the
activity of bemarituzumab against this target.
“Systemic chemotherapy is the standard of care for this deadly
and aggressive form of gastric cancer. We are strongly encouraged
by these data and the potential for a frontline targeted treatment
that can improve overall survival,” said 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. “The
FIGHT trial results demonstrate that treatment with bemarituzumab
in combination with chemotherapy can deliver a significant
reduction in the risk of disease progression and death in gastric
cancer patients whose tumors overexpress FGFR2b.”
“The Phase 2 FIGHT clinical trial results validate our
pioneering work on the role of FGFR2b overexpression in gastric
cancer, and we’re excited about the implications of this new
scientific understanding for other cancers,” said Helen Collins,
M.D., Five Prime’s Executive Vice President and Chief Medical
Officer. “With these data in hand, we plan to continue to
collaborate with regulatory agencies on next steps, initiate a
global Phase 3 trial in gastric cancer and begin studying
bemarituzumab in other epithelial cancers that overexpress
FGFR2b.”
Phase 2 FIGHT Trial: Summary of Efficacy*
Control Arm
Placebo + mFOLFOX6
Investigational Arm
Bema + mFOLFOX6
Statistical Measures
Median PFS, months
All patients (n=155)
7.4
9.5
HR (95% CI): 0.68
(0.44, 1.04); p=0.073
IHC 2+/3+ ≥ 5% (n=118)
7.3
10.2
HR (95% CI): 0.54 (0.33,
0.87)
IHC 2+/3+ ≥ 10% (n=96)
7.3
14.1
HR (95% CI): 0.44 (0.25,
0.77)
Median OS, months
All patients (n=155)
12.9
Not Reached
HR (95% CI): 0.58; (0.35, 0.95);
p=0.027
IHC 2+/3+ ≥ 5% (n=118)
12.5
Not Reached
HR (95% CI): 0.52 (0.30,
0.91)
IHC 2+/3+ ≥ 10% (n=96)
11.1
Not Reached
HR (95% CI): 0.41 (0.22,
0.79)
ORR, %
ORR (Intent to Treat)
33
47
Improved by 13.1%
(p=0.106)
ORR (measurable disease at
baseline)
40
53
Improved by 13%
* All three efficacy endpoints in
the FIGHT Phase 2 trial met pre-specified statistical significance
(2-sided alpha of 0.20)
The incidence of all grade adverse events was similar in the
bemarituzumab and placebo arms of the study (100% vs 98.7%,
respectively). Corneal events were reported more frequently in the
bemarituzumab arm (67.1% vs 10.4%), with the most common corneal
events in the bemarituzumab arm being dry eye (26.3%), keratitis
(15.8%) and punctate keratitis (14.5%). Stomatitis (31.6% vs 13.0%)
and elevated transaminases (34.2% vs 19.5%) were also more common
in the bemarituzumab arm. Grade 3 and higher adverse events (82.9%
vs 74.0%), serious adverse events (31.6% vs 36.4%) and deaths (6.6%
vs 5.2%) were comparable across arms.
Ocular events are common in therapies targeting FGFR and were
also reported in the FIGHT trial. More patients in the FIGHT trial
discontinued bemarituzumab compared to placebo due to an adverse
event (34.2% vs 5.2%) and the majority of these patients (21 of 26
patients) discontinued due to an ocular event.
The discontinuation of bemarituzumab due to an ocular event
decreased the median duration of exposure to bemarituzumab by 3.2
weeks; from 25.3 weeks (n=55, range: 2.0 to 71.7 weeks) to 22.1
weeks (n=21, range: 12.0 to 46.7 weeks).
In designing the Phase 3 trial, the company plans to incorporate
findings from the FIGHT trial including baseline eye exams,
prophylactic lubricating eye drops and close monitoring for signs
and symptoms of corneal toxicity, including dry eye.
Five Prime Webcast /Conference Call Information
Five Prime Therapeutics will host a KOL conference call and live
audio webcast following ASCO GI on Friday, January 15, 2021 at
4:30pm (EST) / 1:30pm (PST) to review the Phase 2 FIGHT clinical
trial results and provide an update on the bemarituzumab program.
The presentation 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 an investigator in the trial.
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 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 splice form of FGFR which can be found
in tumors of epithelial origin. Data from the FIGHT trial suggests
that approximately 30 percent of patients with non HER2 positive
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 cancer (TNBC), ovarian,
pancreatic and intrahepatic cholangiocarcinoma.
About Bemarituzumab
Bemarituzumab (anti-FGFR2b) is a first-in-class targeted
antibody that blocks fibroblast growth factors (FGFs) from binding
and activating FGFR2b, inhibiting several downstream pro-tumor
signaling pathways and potentially slowing cancer progression.
Bemarituzumab is being developed in gastric and GEJ cancer as a
targeted therapy for tumors that overexpress FGFR2b. The company is
also evaluating the potential for bemarituzumab in other cancers
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 negative
patients, frontline 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 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/20210115005136/en/
Media and Investor Contact Martin Forrest VP, Investor
Relations & Corporate Communications Five Prime Therapeutics,
Inc. 415-365-5625 martin.forrest@fiveprime.com
Five Prime Therapeutics (NASDAQ:FPRX)
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