On April 29, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations (Press release, Hoffmann-La Roche , APR 29, 2016, View Source [SID:1234511632]). Schedule your 30 min Free 1stOncology Demo! NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world.1-3 Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year or 90 every day.1,3-5
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"Patients with EGFR mutated lung cancer who were treated with the combination of Avastin plus Tarceva lived significantly longer without their disease progressing compared to patients treated with Tarceva alone." said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. "We are delighted that this strategy of combining targeted medicines has improved patient outcomes. Today’s CHMP opinion brings us one step closer to providing this combination therapy option to patients."
The EU filing was based primarily on data from the pivotal phase II JO25567 study. In the study, patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progres
sing (progression-free survival, PFS) compared to those who received Tarceva alone.5 This represents a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015), meaning the study met its primary endpoint.5 Avastin and Tarceva each target pathways which are known to be key drivers in the growth and development of tumours, and the beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable.6,7
About the JO25567 study
JO25567 is a randomised phase II study conducted by Chugai that assessed the safety and efficacy of first-line Avastin in combination with Tarceva compared to Tarceva alone in Japanese patients with non-squamous NSCLC with EGFR-activating mutations. Study data from 154 patients showed:
Patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing (progression-free survival, PFS) (primary endpoint) compared to those who received Tarceva alone, representing a statistically significant 46 percent reduction in the relative risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015).5
No new and clinically significant adverse events were observed and the toxicity profile was shown to be managable.5