Tarceva (erlotinib)

Results from a Phase III study presented at the American Society for Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida today show that patients with advanced non-small cell lung cancer (NSCLC) who received erlotinib (Tarceva®) as first-line maintenance treatment benefited from a significant (29%) improvement in the time they lived without the disease advancing, compared with those who received placebo.
Tarceva® (erlotinib) is a small molecule Human Epidermal Growth Factor type 1/Epidermal Growth Factor Receptor (HER1/EGFR) inhibitor.
Patients in the global multicentre SATURN trial, which included patients from the UK, received maintenance treatment with erlotinib if their cancer had not progressed on initial chemotherapy. The data showed a significant improvement in the length of time patients lived without their disease getting worse, and without the need for further chemotherapy. The improvement was seen in both of the main types of NSCLC (squamous cell as well as non-squamous cell) and these results form the basis of a submission for regulatory approval of erlotinib to be used in the first-line maintenance setting.

SATURN is a global multicentre, double blind, randomised, prospective Phase III study to evaluate the efficacy of erlotinib or placebo in patients with advanced, recurrent or metastatic NSCLC who had not progressed following first line platinum based chemotherapy. The study involved more than 880 patients from approximately 160 centres; 438 received erlotinib and 451 placebo. The study met its primary endpoint demonstrating a statistically significant extension of the time patients live without their disease worsening; there was a 29% increase compared with placebo (hazard ratio= 0.71. p-value <0.0001). Imperial Healthcare NHS Trust, London, said : «SATURN brings welcome news for NSCLC patients in the UK and their families, and represents a new milestone in the treatment of the disease. Stopping the cancer growing for as long as possible reduces symptoms and helps improve the patient's life. Being able to achieve these benefits without the need for chemotherapy is important since the side effects of chemotherapy add considerably to the physical and psychological burden of cancer for many patients.»

NSCLC progresses rapidly and less than 5% of advanced NSCLC patients survive for 5 years. Extending the time patients live without their disease progressing whilst managing side effects are key treatment goals. Erlotinib is already approved for use by NICE3 and the SMC4 as an alternative to chemotherapy in second-line treatment in patients whose cancer returns following chemotherapy, giving patients the choice of an oral, well tolerated treatment. These new data show erlotinib to be effective in delaying progression of the disease in NSCLC patients who do respond to chemotherapy.

Important results from tissue samples collected as part of the SATURN study protocol have provided important information on the potential role of biomarkers, such as EGFR and K-ras mutations, in predicting possible outcomes of erlotinib therapy in NSCLC patients. An analysis of patients whose tumours possessed an activating EGFR mutation (a small difference in the structure of the EGFR protein found on the surface of the cancer cell) demonstrated a significantly more pronounced increase in the time patients live without their disease worsening than in the majority of patients with unmutated (or "wild type") EGFR.