Small but Statistically Significant Improvement in Overall Survival With Second-Line Addition of Ramucirumab to Docetaxel in Stage IV NSCLC

Editor’s note: This article covers the results of a clinical trial—a research study with volunteer patients. The goal of the trial was to test the effectiveness of adding a drug called ramucirumab (aka Cyramza) to treatment with the chemotherapy drug docetaxel. The patients who participated all had non-small cell lung cancer (NSCLC) that had worsened during platinum-based chemotherapy. The researchers found that ramucirumab provided patients with a small but significant improvement in survival time.

“In the phase III REVEL trial reported in The Lancet, Garon et al found that the addition of the  antiangiogenic VEGFR-2 inhibitor ramucirumab (Cyramza) to docetaxel produced a statistically significant improvement in overall survival as second-line treatment in patients with stage IV non–small cell lung cancer (NSCLC) after progression on platinum-based therapy…

“In this double-blind trial, 1,253 patients with squamous or nonsquamous stage IV NSCLC from academic medical centers and community clinics in 26 countries on six continents were randomly assigned between December 2010 and January 2013 to receive docetaxel at 75 mg/m² and either ramucirumab at 10 mg/kg (n = 628) or placebo (n = 625) on day 1 of 21-day cycles until disease progression, unacceptable toxicity, withdrawal, or death. Patients had to have progressed during or after a single platinum-based chemotherapy regimen, with or without bevacizumab (Avastin) or maintenance therapy.

“Randomization was stratified by sex, region, performance status, and previous maintenance therapy. The primary endpoint was overall survival in the intent-to-treat population.”


Docetaxel Plus Ramucirumab Improves Outcomes in Advanced NSCLC

“The addition of ramucirumab to docetaxel improved outcomes over placebo with docetaxel as a second-line treatment of patients with advanced non-small-cell lung cancer (NSCLC), according to results of the REVEL trial presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

“ ‘Despite advancements in genomics and identification of predictive biomarkers such as EGFR mutations or ALK rearrangement, there is still no… targeted therapy for the majority of patients with squamous and non-squamous carcinoma,’ said Maurice Pérol, MD, of the Cancer Research Center of Lyon in France. Ramucirumab specifically targets VEGFR-2 and inhibits angiogenesis, and it has been shown to improve outcomes in gastric cancer as monotherapy.”

Editor’s note: This article describes a treatment for advanced non-small cell lung cancer (NSCLC) that combines a new targeted drug called ramucirumab with the standard chemotherapy drug docetaxel. In a clinical trial to test the treatment in volunteer patients who had already received one previous treatment, it was found that ramucirumab plus docetaxel provided better patient outcomes than docetaxel plus a placebo.


Cyramza Yields a Modest Survival Benefit in Second-line NSCLC

“Cyramza™ (ramucirumab, IMC-1121B; Eli Lilly) is a human IgG1 monoclonal antibody directed against the extracellular domain of VEGFR-2. It was recently approved by the Food and Drug Administration (FDA) for advanced gastric cancer or gastroesophageal junction adenocarcinoma. On February 19, 2014, Lilly announced via press release that the REVEL trial was positive for both overall survival (OS) and progression-free survival (PFS) benefit. Results from the randomized, double-blind, placebo-controlled Phase III REVEL trial (NCT01168973) were reported at the 2014 annual meeting of the American Society of Clinical Oncology (ASCO). The trial evaluated docetaxel with or without Cyramza in squamous or non-squamous Stage IV non-small cell lung cancer (NSCLC) patients following disease progression after one prior platinum-based therapy.”

Editor’s note: A new targeted drug called Cyramza (aka ramucirumab) shows promise as a potential treatment for people with advanced non-small cell lung cancer (NSCLC). In a clinical trial, scientists tested the drug on volunteer patients with stage IV NSCLC. Compared to standard chemotherapy alone, patients who were treated with chemo plus Cyramza lived longer and had more time pass before their cancer worsened.

Update 6/9/14: According to Dr. Jack West of GRACE, the benefit of Cyramza is very minimal in the above-mentioned clinical trial, and is therefore not so promising.