Meta-Analysis Examines Adverse Events for Ramucirumab in Patients with Advanced Solid Tumors

By Adam Hochron

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With ramucirumab approved for the treatment of several advanced solid tumors, a recent systemic review and meta-analysis of ten randomized controlled trials looked at the risk-benefit of the drug across several solid tumor types. 

Ramucirumab is an VEGF2 inhibitor first approved as a monotherapy by the FDA in 2014 for the treatment of metastatic gastric cancer. It is also approved for gastric cancer in combination with paclitaxel, non-small cell lung cancer (NSCLC) in combination with docetaxel, colorectal cancer in combination with FOLFIRI, hepatocellular cancer as monotherapy and most recently in epidermal growth factor receptor (EGFR) positive NSCLC in combination with erlotinib.

According to results published in EClinicalMedicine, when compared to the control arm, patients treated with ramucirumab were at a significantly increased risk of serious adverse events (RR 1.13, 95% CI; 1.05-1.21, incidence 37.5% vs. 33.5). However, the increase in the risk of fatal adverse events was deemed not statistically significant (RR 1.41, 95% CI; 0.96-2.07, incidence 1.8 vs. 1.3%). 

Looking at the overall results, the authors noted that the incidence of treatment-related mortality with ramucirumab was 1.8%, which, they said, was not significantly higher than patients in the control arms of the studies reviewed. In reviewing the efficacy of the treatment, the authors said the treatment resulted in a median overall survival from 1.2 to 2.2 months, with a hazard ratio of 0.71 to 0.86, which the authors described as “marginal gains in survival that need to be judged against the increased risk of toxicities.” 

While safety and efficacy are important factors to consider when determining the right treatment options, the authors also said cost needs to be looked at as well. According to their research, ramucirumab costs around $14,000 in the United States. The revenue from sales of the drug in the US was $335.3 million in 2019. 

“Whether such investment is warranted for the given risk-benefit profile is up to the individual regulatory and reimbursement agencies to decide, but analyses such as ours will be helpful for countries in priority setting making such decisions,” the authors said. “Objective assessment of risks and benefits of expensive cancer drugs will help to identify low-value drugs and make priority decisions for the health care systems.” 

The authors said that for metastatic cancer drugs, weighing the risks and benefits “is the most crucial aspect of shared treatment decision making.” Even after the drugs are approved, the authors note there is more work to be done to ensure that they are providing the benefits in the real-world setting that they showed during clinical trials. 

“In this meta-analysis, we find that the use of ramucirumab was associated with a significantly increased risk of serious adverse events while the clinical benefit from ramucirumab was negligible to moderate based on ESMO-Magnitude of Clinical Benefit Scale,” the authors said. “This risk-benefit profile of ramucirumab suggests that it is a low-value cancer drug. This information must be carefully considered during clinical, regulatory, and reimbursement decisions.”


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