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Lilly's CYRAMZA® (ramucirumab) Phase 3 RELAY Trial Met Primary Endpoint, Significantly Improving Progression-Free Survival in First-Line Treatment of Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

(Lilly) Mar 12, 2019 - Eli Lilly and Company today announced that its Phase 3 RELAY study of CYRAMZA® (ramucirumab) met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment. The Phase 3 global, randomized, double-blind trial is evaluating CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating EGFR mutations.

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H. Jack West, MD (Posted: March 12, 2019)

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This is an interesting and important finding, but the lack of an overall survival (OS) benefit will mean it should not have any significant clinical impact, since we already have data from Japan that have shown a reproducible improvement in progression-free survival (PFS) that has been quite profound but has thus far failed to translate into an improvement in overall survival. While a substantial improvement in PFS without an improvement in OS sometimes dictates a change in practice, the Japanese data have not led to any appreciable shift in practice since these data became available, generally due to the added cost, the introduction of an IV therapy that requires patients to come to clinic more than they would for oral therapy alone, and some toxicity risk. Because ramucirumab on the RELAY trial essentially just replicates the findings already seen with the erlotinib/bevacizumab combination, it's very difficult to imagine it leading to a different approach based on a very similar trial and agent. We would need to see a significant improvement in OS. Even then, osimertinib has become the first line standard of care, so the leading trial needs to be an anti-angiogenic agent with osimertinib in this setting. An alternative first line approach with considerable interest is that of chemo combined with osimertinib first line, based on the results of the NEJ-009 trial presented at ASCO 2018, which demonstrated not only a significant improvement in PFS and even OS with the combination of carbo/pemetrexed/gefitinib over gefitinib followed by chemo.

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