Ramucirumab similarly beneficial for Asian patients with advanced HCC
Treatment with ramucirumab, a human IgG1 monoclonal antibody, significantly improves overall survival (OS) in patients with advanced hepatocellular carcinoma (HCC) in both Asians and non-Asians, based on a pooled analysis of REACH* and REACH-2** studies presented at ESMO Asia 2018.
“This subgroup analysis demonstrates significant survival benefits of ramucirumab treatment in Asian and non-Asian patients with advanced HCC and alpha-fetoprotein (AFP) level [of] ≥400 ng/mL,” said Dr Chia-Jui Yen from the National Cheng Kung University in Tainan City, Taiwan.
REACH and REACH-2 were comparable trials with similar study design that enrolled 291 Asian and 251 non-Asian patients with HCC who had elevated AFP levels at baseline. Patients were randomized to receive intravenous ramucirumab (8 mg/kg) or placebo every 2 weeks, and all patients received best supportive care. Patients continued treatment until disease progression, unacceptable toxicity, or study withdrawal. [ESMO Asia 2018, abstract 1490]
Both Asian and non-Asian patients demonstrated a significantly higher OS with ramucirumab compared with placebo (median, 8.08 vs 4.76 months, hazard ratio [HR], 0.73, 95 percent confidence interval [CI], 0.56–0.95; log-rank p=0.0189 for Asians and 7.98 vs 5.22 months, HR, 0.65, 95 percent CI, 0.49–0.86; log-rank p=0.0028 for non-Asians).
Patients on ramucirumab also experienced a significantly longer progression-free survival (PFS) than those on placebo (median, 2.73 vs 1.45 months, HR, 0.58, 95 percent CI, 0.44–0.76; log-rank p<0.0001 in Asians and 3.06 vs 1.87 months, HR, 0.55, 95 percent CI, 0.41–0.73; log-rank p<0.0001 in non-Asians).
Higher objective response rate was also observed in the ramucirumab group than the placebo group for both Asians and non-Asians though only significant in non-Asians (4.2 percent vs 0.8 percent; p=0.1320 for Asians and 6.8 percent vs 1.0 percent; p=0.0270 for non-Asians).
Similarly, disease control rate was significantly higher in the ramucirumab vs the placebo groups (53.6 percent vs 33.3 percent; p=0.0043 for Asians and 59.5 percent vs 41.70 percent; p=0.0067 for non-Asians).
A higher incidence of grade ≥3 hypertension was observed in both Asians and non-Asians who received ramucirumab compared with placebo (7.7 percent vs 2.5 percent and 16.9 percent vs 4.9 percent, respectively).
“[Nevertheless,] treatment with ramucirumab was well tolerated, with similar safety profiles between Asian and non-Asian patients,” said Yen.
“Ramucirumab represents an important new potential treatment option for Asian patients with HCC and an elevated AFP after prior sorafenib treatment, a population associated with poor prognosis and aggressive disease,” Yen added.
*REACH: A study of ramucirumab (IMC-1121B) drug product (DP) and best supportive care (BSC) versus placebo and BSC as 2nd-line treatment in participants with hepatocellular carcinoma after 1st-line therapy with sorafenib
**REACH-2: A study of ramucirumab (LY3009806) versus placebo in participants with hepatocellular carcinoma and elevated baseline alpha-fetoprotein