Ramucirumab

The REACH trial (NCT01140347) randomly assigned 565 patients with advanced HCC to receive either ramucirumab or placebo after first-line sorafenib. The primary end point was OS.[19][Level of evidence A1]

The REACH trial (NCT01140347) randomly assigned 565 patients with advanced HCC to receive either ramucirumab or placebo after first-line sorafenib. The primary end point was OS.[19][Level of evidence A1]

The OS benefit was not statistically significant (9.2 months [95% CI, 8.0–10.6] in the ramucirumab arm and 7.6 months [95% CI, 6.0–9.3] in the placebo arm).

The REACH trial (NCT01140347) randomly assigned 565 patients with advanced HCC to receive either ramucirumab or placebo after first-line sorafenib. The primary end point was OS.[19][Level of evidence A1]

An unplanned subgroup analysis showed that patients with an AFP response had improved survival compared with patients who did not.

The REACH-2 trial (NCT02435433) included 292 patients with an Eastern Cooperative Oncology Group performance status of 0 or 1, an AFP level of at least 400 ng/mL, and Child-Pugh class A liver disease who had previously received sorafenib. Patients were randomly assigned to receive either ramucirumab or placebo.[20,21][Level of evidence A1]

The REACH-2 trial (NCT02435433) included 292 patients with an Eastern Cooperative Oncology Group performance status of 0 or 1, an AFP level of at least 400 ng/mL, and Child-Pugh class A liver disease who had previously received sorafenib. Patients were randomly assigned to receive either ramucirumab or placebo.[20,21][Level of evidence A1]

OS and PFS were improved in patients who received ramucirumab. The median OS was 8.5 months (95% CI, 7.0–10.6) for patients who received ramucirumab and 7.3 months (95% CI, 5.4–9.1) for patients who received placebo (HR, 0.710; 95% CI, 0.531–0.949; P = .0199).

A pooled analysis of the patients in the REACH trial with an AFP greater than 400 ng/mL and the patients in REACH-2 showed improved survival regardless of Barcelona Clinic Liver Cancer (BCLC) stage.[22][Level of evidence C1]

A pooled analysis of the patients in the REACH trial with an AFP greater than 400 ng/mL and the patients in REACH-2 showed improved survival regardless of Barcelona Clinic Liver Cancer (BCLC) stage.[22][Level of evidence C1]

Among patients with BCLC stage B disease, the median OS was 13.7 months for the ramucirumab group and 8.2 months for the placebo group (HR, 0.43; 95% CI, 0.23–0.83). Among patients with BCLC stage C disease, the median OS was 7.7 months for the ramucirumab group and 4.8 months for the placebo group (HR, 0.72; 95% CI, 0.59–0.89).