With a median follow-up of 12.5 months, the addition of bemarituzumab to chemotherapy resulted in a median OS of 19.2 months versus 13.5 months for chemotherapy alone in all randomized patients (n=155, HR: 0.6; 95% CI: 0.38, 0.94). In an exploratory pre-specified subgroup analysis, in patients with >10% of tumor cells overexpressing FGFR2b by immunohistochemistry (IHC), the median OS for bemarituzumab was 25.4 months versus 11.1 months (n=96, HR: 0.41; 95% CI: 0.23, 0.74).
The incidence of all grade adverse events was similar in the bemarituzumab plus chemotherapy and chemotherapy only arm of the study (100% versus 98.7%, respectively). The incidence of corneal adverse events was higher in the bemarituzumab plus chemotherapy arm versus the chemotherapy arm (all grade AEs 67.1% versus 10.4%), with dry eye reported as the most common corneal event (26.3%). The majority of the corneal adverse events were reversible.
The results were presented today in an oral presentation at the 2021
"Gastric cancer is the fourth leading cause of cancer death globally and 30% of frontline HER2-negative gastric cancer patients have tumors that overexpress FGFR2b," said
More than one million new gastric cancer cases are diagnosed annually, and gastric cancer is particularly prevalent in Asia.1,2 Approximately 80 to 85% of advanced gastric and GEJ cancers are HER2-negative, and approximately 30% of these tumors overexpress FGFR2b.3,4
"These updated results further validate our work on the role of FGFR2b overexpression in gastroesophageal cancer and demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a clinically significant reduction in the risk of disease progression for patients whose tumors overexpress FGFR2b," said
Bemarituzumab (anti-FGFR2b) is a Phase 3 ready, potential first-in-class, investigational targeted antibody that is designed to block specific 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.
Zai Lab (Shanghai) Co. Ltd. was granted an exclusive license to develop and commercialize bemarituzumab in
The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b-positive, HER2-negative frontline advanced gastric or GEJ cancer. In the study, treatment with bemarituzumab plus chemotherapy demonstrated clinically significant and substantial improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in the patient population in which at least 10% of tumor cells overexpressed FGFR2b. Additional analysis showed a positive correlation between benefit and the prevalence of FGFR2b+ tumor cells, affirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target. The Breakthrough Therapy Designation was granted based upon this subset of patients who showed at least 10% of tumor cells overexpressing FGFR2b.
At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.
At Amgen, we're advancing oncology at the speed of life™.
For more information, follow us on www.twitter.com/amgenoncology.
This news release contains forward-looking statements that are based on the current expectations and beliefs of
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
CONTACT: Amgen, Thousand Oaks
1 Bray F, et al. CA Cancer J Clin. 2018;68:394–424.
2 Rawla P, et al. Prz Gastroenterol. 2019;14(1):26-38. doi:10.5114/pg.2018.80001.
3 Shitara K et al. NEJM. 2020; 382;25: 2419-30.
4 Wainberg ZA, et al. Presented at: ASCO Gastrointestinal Cancer Symposium; January 15-16, 2021; Online Virtual Scientific Program (Abstract LBA160 and oral presentation).
View original content to download multimedia:http://www.prnewswire.com/news-releases/phase-2-fight-trial-continues-to-show-improved-overall-survival-with-bemarituzumab-plus-chemotherapy-in-patients-with-fgfr2b-gastric-and-gastroesophageal-cancers-301305762.html