Phase 2 Study Update of Rilotumumab (AMG 102) for Gastric and Gastroesophageal Cancer

Amgen announced results from an exploratory biomarker analysis evaluating MET expression as a predictor of clinical response to rilotumumab (AMG 102) conducted on a previously reported Phase 2 study of rilotumumab in patients with locally advanced or metastatic gastric or gastroesophageal cancer. The analysis showed that treatment with rilotumumab in combination with chemotherapy improved median overall survival (OS) in patients whose tumors exhibited high MET protein expression.

In the Phase 2, three-arm trial, 121 patients were randomized 1:1:1 to receive epirubicin, cisplatin and capecitabine (50mg/m2 IV Day 1, 60mg/m2 IV Day 1, 625mg/m2 twice daily orally Days 1-21, respectively) in combination with two different dose levels of rilotumumab (Arm A 15mg/kg every 3 weeks, n=40; Arm B 7.5mg/kg every 3 weeks, n=42) or placebo (Arm C, n=39). The primary endpoint of the study was PFS. Secondary endpoints included OS, objective response rate (ORR) and safety. In the biomarker analysis, 90 patients were evaluated for MET protein levels using an immunohistochemistry test. Twenty-seven patients from the rilotumumab treatment arms and 11 patients who received placebo were found to have tumors with high MET expression, defined as >50% of tumor cells testing positive for the MET protein.  

In this exploratory analysis, the addition of rilotumumab to chemotherapy in patients with gastric tumors with high MET expression improved median OS from 5.7 months to 11.1 months (HR=0.29, 95% CI, 0.11–0.76). Conversely, in patients with gastric tumors with low MET expression, the addition of rilotumumab to chemotherapy was associated with a trend towards unfavorable OS (HR=1.84, 95% CI, 0.78–4.34).

Primary results of the study showed that the primary endpoint of progression-free survival (PFS) had a trend towards a better outcome with rilotumumab plus chemotherapy. The addition of rilotumumab to chemotherapy improved median PFS from 4.2 months to 5.6 months (HR=0.64, 80% CI, 0.48–0.85). The secondary endpoint of OS also trended in favor of rilotumumab, with improved median OS from 8.9 months to 11.1 months (HR=0.73, 80% CI, 0.53–1.01).

Rilotumumab is an investigational fully human monoclonal antibody designed to inhibit the hepatocyte growth factor/scatter factor (HGF/SF): MET pathway.

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