Five Prime to Present Phase 2 FIGHT Trial Results of Bemarituzumab at American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Virtual Annual Symposium
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 15at 1:30pm PST/ 4:30pm EST
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
The Company will host a conference call and live audio webcast on
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 Researchat the Jonsson Comprehensive Cancer Center
Conference Call Information
Five Prime will host a conference call and live audio webcast on
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
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
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
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
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
1. Data on file.
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,
4. Drugs approved for stomach (gastric) cancer.
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