Eli Lilly's VEGFR-2 Monoclonal Antibody Ramucirumab Receives CDE Acceptance for NDA in Gastric Cancer

Source: Medical Perspective

The latest public announcement from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration indicates that Eli Lilly and Company has submitted a marketing application in China for ramucirumab, an innovative monoclonal antibody targeting VEGFR-2, which was accepted on January 21. Based on Eli Lilly’s earlier press release, the indication sought in this application is presumed to be second-line treatment for advanced gastric cancer.

Source: CDE Official Website

Ramucirumab is a fully human IgG1 monoclonal antibody that specifically binds to VEGFR-2 (vascular endothelial growth factor receptor 2). This drug not only efficiently blocks the binding of VEGF-A to VEGFR-2, but also inhibits the binding of VEGF-C and VEGF-D to VEGFR-2.

On January 12, 2021, Eli Lilly and Company announced that ramucirumab met the prespecified primary endpoint in the latest Phase 3 RAINBOW-Asia clinical trial. The RAINBOW-Asia study is a Phase 3 trial conducted in East Asia (China, Malaysia, the Philippines, and Thailand), led by Professor Shen Lin from Peking University Cancer Hospital and Professor Xu Ruihua from Sun Yat-sen University Cancer Center. The study enrolled a total of 440 patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma who had progressed after first-line chemotherapy from the aforementioned regions, the vast majority of whom were Chinese patients. Enrolled patients were randomized in a 2:1 ratio to receive either ramucirumab plus paclitaxel or placebo plus paclitaxel.

The study results showed that, compared with the placebo group, ramucirumab in combination with paclitaxel significantly prolonged the median progression-free survival (4.14 months vs. 3.15 months) and demonstrated a median overall survival (OS) benefit consistent with the global pivotal registration trial RAINBOW (HR=0.963). Furthermore, the overall tolerability was favorable, consistent with the known safety profile of ramucirumab, and no new safety signals were observed.

Eli Lilly stated in a press release that it would use the results of the RAINBOW-Asia study to support the registration application for ramucirumab in China. It can thus be inferred that the marketing authorization application for ramucirumab currently submitted in China is for the second-line treatment of advanced gastric cancer.

According to a press release previously issued by Eli Lilly, there is currently no standard second-line treatment regimen for advanced gastric cancer in China. The RAINBOW-Asia study is the first and, to date, the only Phase 3 trial to confirm the clinical benefit of anti-angiogenic therapy in the second-line setting for advanced gastric cancer, predominantly among Chinese patients. Eli Lilly and Company has presented the detailed study results at the latest 2021 ASCO Gastrointestinal Cancers Symposium (ASCO-GI).

The latest cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization indicate that gastric cancer is the third most common malignant tumor in China in terms of incidence. In 2020, there were approximately 480,000 new cases of gastric cancer in China, accounting for about 44% of the global new cases. In the same year, the number of deaths caused by gastric cancer in China reached 370,000, representing nearly half of the global gastric cancer mortality. There is an urgent need for new treatment options for gastric cancer patients in China.

Congratulations to Eli Lilly and Company on the acceptance of its marketing application in China for ramucirumab, an innovative monoclonal antibody targeting VEGFR-2. We hope that the drug will be approved and launched soon, bringing new treatment options and hope for survival to Chinese patients with advanced gastric cancer.

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