Pharma Strategy Blog

In patients with advanced non-small-cell lung cancer (NSCLC), the addition of the targeted agent cetuximab (Erbitux) to platinum-based chemotherapy offers a small survival advantage. Patients given chemotherapy plus cetuximab had a median overall survival of 11.3 months, compared with 10.1 months for control subjects. Is a month enough given the high cost of the therapy? Should we expect more?

Vandetanib demonstrated a significant prolongation of progression-free survival compared with gefitinib in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) in a recent study by U.S. and European researchers. However, overall survival was not improved.

New results from the phase 3 SATURN trial show that erlotinib (Tarceva) maintenance therapy significantly improves overall survival in nonsmall-cell lung cancer (NSCLC) patients. However, although the survival was significant, the real improvement was only one extra month of benefit.

Achieving an early response with imatinib is protective against treatment failure; second-generation tyrosine kinase inhibitors (TKIs; for example, nilotinib, dasatinib, bosutinib), however, have proven to be efficacious at restoring cytogenetic responses in patients who require subsequent therapy. Response duration, however, is yet to be established and a considerable proportion of patients fail to achieve a clinically meaningful response.

In imatinib-treated CML, secondary drug resistance is often caused by mutations in the BCR-ABL kinase domain (KD). As alternative therapies are available for imatinib resistance, early identification of mutations may prevent disease progression. Since most patients are routinely monitored by BCR-ABL quantitative PCR, it is important to define the optimal increase in BCR-ABL that should trigger mutation testing. Patients with CML who have a 2.6-fold or greater increase in BCR-ABL RNA transcript levels by RQ-PCR should be screened for kinase-domain mutations associated with imatinib resistance.