ImClone/BMS/Merck KGaA: Erbitux Approval in Lung Cancer Now Likely
Posted on: Wednesday, 4 June 2008, 06:00 CDT
Erbitux has become the first EGFR-targeted agent to demonstrate a survival improvement in combination with chemotherapy in the first-line treatment of advanced NSCLC. While physicians' perception of Erbitux's efficacy and applicability remains to be seen, these latest results are likely to gain Erbitux regulatory approval in advanced NSCLC, a market characterized by a high level of unmet need.
Erbitux has become the first EGFR-targeted agent to demonstrate a survival improvement in combination with chemotherapy in the first-line treatment of advanced NSCLC. While physicians' perception of Erbitux's efficacy and applicability remains to be seen, these latest results are likely to gain Erbitux regulatory approval in advanced NSCLC, a market characterized by a high level of unmet need.
The FLEX (First-Line Treatment for Patients with EGFR-Expressing Advanced NSCLC) trial, sponsored by ImClone's European marketing partner Merck KGaA, randomized 1,125 patients with EGFR-detectable advanced (Stage IIIB/IV) NSCLC to Erbitux (cetuximab) plus chemotherapy (cisplatin and vinorelbine) versus chemotherapy alone. The overall survival was 11.3 months for patients treated with Erbitux, compared with 10.1 months for patients treated with chemotherapy only.
However, this survival improvement of 1.2 months came close to missing statistical significance, with a p-value of 0.044. The statistical power of the trial could generate delays in Erbitux's approval if it prompts the FDA to request additional data. On secondary endpoint analysis, the response rate was higher in Erbitux-treated patients but the median progression-free survival was the same in both arms of the study.
Currently, Avastin (bevacizumab; Genentech/Roche) is the only targeted therapy approved for the first-line treatment of advanced NSCLC. However, Erbitux will not necessarily compete with Avastin in this treatment setting. Avastin is approved in combination with chemotherapy (carboplatin and paclitaxel) for advanced NSCLC patients with non-squamous cell carcinoma (non-SCC), a histological subtype of NSCLC. It is the SCC patients - accounting for about 30% of all lung cancer cases - and other "Avastin-ineligible" patients who are likely to be Erbitux's target patient pool. In the FLEX trial, Erbitux increased the overall survival of Caucasian SCC patients by 1.3 months. Although this result did not reach statistical significance, it showed that Erbitux is safe in this currently underserved patient population.
The FLEX trial's results may generate some controversy among physicians regarding their clinical significance, particularly in comparison with Avastin. However, in a market characterized by a high level of unmet need, the FLEX trial is ultimately likely to drive Erbitux's approval and uptake in the first-line treatment of advanced NSCLC. The precise way in which Erbitux will alter the current standards of care will become apparent once clinical practice experience and biomarker studies help define the patient populations who are most likely to benefit from treatment.
Source: Datamonitor
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