Gemcitabine in combination with ramucirumab

A multicenter, randomized, double-blind, placebo-controlled, phase II trial (RAMES [NCT03560973]) included 161 patients with malignant pleural mesothelioma that progressed during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive either gemcitabine plus ramucirumab, an anti-VEGFR-2 antibody (n = 80), or gemcitabine plus placebo (n = 81). The primary end point was overall survival (OS).[10] Of note, patients enrolled in the RAMES trial had no previous exposure to bevacizumab or immune checkpoint inhibitors.

A multicenter, randomized, double-blind, placebo-controlled, phase II trial (RAMES [NCT03560973]) included 161 patients with malignant pleural mesothelioma that progressed during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive either gemcitabine plus ramucirumab, an anti-VEGFR-2 antibody (n = 80), or gemcitabine plus placebo (n = 81). The primary end point was overall survival (OS).[10] Of note, patients enrolled in the RAMES trial had no previous exposure to bevacizumab or immune checkpoint inhibitors.

The median OS was 13.8 months (70% confidence interval [CI], 12.7–14.4) in the gemcitabine-plus-ramucirumab group and 7.5 months (70% CI, 6.9–8.9) in the gemcitabine-plus-placebo group (hazard ratio [HR], 0.71; 70% CI, 0.59–0.85; P = .028).[10][Level of evidence A1]

A multicenter, randomized, double-blind, placebo-controlled, phase II trial (RAMES [NCT03560973]) included 161 patients with malignant pleural mesothelioma that progressed during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive either gemcitabine plus ramucirumab, an anti-VEGFR-2 antibody (n = 80), or gemcitabine plus placebo (n = 81). The primary end point was overall survival (OS).[10] Of note, patients enrolled in the RAMES trial had no previous exposure to bevacizumab or immune checkpoint inhibitors.

The median progression-free survival (PFS), although longer in the gemcitabine-plus-ramucirumab group, was not significantly different (HR, 0.79; 70% CI, 0.66–0.94; P = .082).

A multicenter, randomized, double-blind, placebo-controlled, phase II trial (RAMES [NCT03560973]) included 161 patients with malignant pleural mesothelioma that progressed during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive either gemcitabine plus ramucirumab, an anti-VEGFR-2 antibody (n = 80), or gemcitabine plus placebo (n = 81). The primary end point was overall survival (OS).[10] Of note, patients enrolled in the RAMES trial had no previous exposure to bevacizumab or immune checkpoint inhibitors.

More patients who received gemcitabine plus ramucirumab had controlled disease than patients who received gemcitabine plus placebo (73% [70% CI, 66%–78%] vs. 52% [70% CI, 46%–58%]).

A multicenter, randomized, double-blind, placebo-controlled, phase II trial (RAMES [NCT03560973]) included 161 patients with malignant pleural mesothelioma that progressed during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive either gemcitabine plus ramucirumab, an anti-VEGFR-2 antibody (n = 80), or gemcitabine plus placebo (n = 81). The primary end point was overall survival (OS).[10] Of note, patients enrolled in the RAMES trial had no previous exposure to bevacizumab or immune checkpoint inhibitors.

Grade 3 to 4 treatment-related adverse events were reported in 35 of 80 patients (44%) who received gemcitabine plus ramucirumab and 24 of 81 patients (30%) who received gemcitabine plus placebo.

A multicenter, randomized, double-blind, placebo-controlled, phase II trial (RAMES [NCT03560973]) included 161 patients with malignant pleural mesothelioma that progressed during or after first-line treatment with pemetrexed plus platinum. Patients were randomly assigned (1:1) to receive either gemcitabine plus ramucirumab, an anti-VEGFR-2 antibody (n = 80), or gemcitabine plus placebo (n = 81). The primary end point was overall survival (OS).[10] Of note, patients enrolled in the RAMES trial had no previous exposure to bevacizumab or immune checkpoint inhibitors.

There were no treatment-related deaths in either study group.