IASLC 2017: REVEL Trial Subgroup Analysis Further Clarifies Outcomes With Ramucirumab Plus Docetaxel in Advanced Non–Small Cell Lung Cancer
New subgroup analysis from the phase III REVEL trial of ramucirumab (Cyramza) in advanced non–small cell lung cancer (NSCLC) was presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan. Specifically, these new data are an exploratory, post hoc analysis focused on patients whose cancer rapidly progressed on first-line therapy. Time to progression is defined as the time from start of first-line therapy until progressive disease. In this analysis, aggressive disease was defined based on rapid time to progression on first-line therapy.
“Despite recent advancements, patients with aggressive, rapidly progressing advanced non–small cell lung cancer who progress before or at the time of their first scan—which is typically done between 9 and 12 weeks—often have a less favorable response to their second-line therapy. This is a population that has poor prognosis and immediate unmet needs with limited treatment options,” said Martin Reck, MD, PhD, of the Department of Thoracic Oncology at the LungenClinic Grosshansdorf. Dr. Reck continued, “This REVEL exploratory analysis demonstrated that efficacy, safety, and quality-of-life outcomes among patients receiving ramucirumab plus docetaxel who have aggressive disease with rapid progression on first-line therapy are consistent with the outcomes of the intent-to-treat population. These results suggest that such patients may derive meaningful benefit from ramucirumab plus docetaxel in the second-line setting.”
REVEL Trial
The global, randomized, double-blind, placebo-controlled REVEL phase III study evaluated ramucirumab, in combination with docetaxel, in patients with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. REVEL, which included patients with nonsquamous and squamous forms of NSCLC, demonstrated improved overall survival, progression-free survival, and objective response rate—independent of histology.
This new subgroup analysis focused on outcomes from patients according to their time to progression on first-line treatment. Of the 1,253 patients enrolled in REVEL, on first-line therapy, 11% (n = 133) had a time to progression of ≤ 9 weeks, 17% (n = 209) had a time to progression of ≤ 12 weeks, and 28% (n = 354) had a time to progression of ≤ 18 weeks. Baseline characteristics of each subgroup were balanced between treatment arms.
The results show that the trend for overall and progression-free survival outcomes favored the ramucirumab-plus-docetaxel treatment arm, with hazard ratios similar to those of the intent-to-treat population. In all three subpopulations, objective response rate also favored the ramucirumab-plus-docetaxel treatment arm.
Safety overview outcomes from patients with a time to progression on first-line therapy ≤ 18 weeks are similar to what was observed from patients with a time to progression on first-line therapy ≤ 9 weeks and ≤ 12 weeks, as well as in the intent-to-treat population. There were no new safety signals observed in these subpopulations.
“We are encouraged by this REVEL subgroup analysis, as patients with this aggressive type of cancer who experience rapid disease progression on first-line therapy urgently need additional treatment options that can help stop or slow the cancer from growing and spreading,” said Levi Garraway, MD, PhD, Senior Vice President, Global Development and Medical Affairs, Lilly Oncology.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
