Eli Lilly announced Tuesday that a Phase III study of Cyramza (ramucirumab) as a first-line treatment in patients with metastatic non-small-cell lung cancer (NSCLC) whose tumours have activating EGFR mutations met its primary endpoint of progression-free survival (PFS). The company said that it plans to initiate global regulatory submissions for the drug in this indication in mid-2019.
The RELAY trial randomised 449 patients with metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations to receive either Cyramza or placebo, both in combination with Astellas and Roche's Tarceva (erlotinib). In addition to the assessment of PFS, key secondary endpoints included safety, response rate, overall survival and patient-reported outcomes.
Eli Lilly noted that Cyramza demonstrated a significant improvement in the time patients lived without their cancer growing or spreading after starting treatment compared to placebo. The drugmaker added that the safety profile of the therapy was consistent with previous studies, with the most common severe events in patients given Cyramza plus Tarceva including hypertension, dermatitis acneiform and diarrhoea. The company added that detailed efficacy and safety results from the trial will be submitted for presentation at a medical meeting.
Cyramza, which generated sales growth of 8 percent in the fourth quarter of 2018 to $220.6 million, was initially authorised in the US in 2014 for the treatment of certain patients with unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma angiogenesis. The VEGF receptor 2 antagonist is also approved by the FDA for the treatment of advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma in combination with paclitaxel, metastatic non-small-cell lung cancer in patients whose disease progressed during or following treatment with platinum-based chemotherapy and metastatic colorectal cancer.
Last year, Eli Lilly reported that the Phase III REACH-2 trial of Cyramza in the second-line treatment of people with hepatocellular carcinoma met its primary endpoint of overall survival, as well as its secondary goal of PFS. Regulatory filings based on these results have been submitted in the US, EU and Japan.
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