Roche announced new data released at the 35th European Society for Medical Oncology (ESMO) congress showing significant progress for people living with lung cancer.
“We are pleased to be able to share this new data in lung cancer regarding Tarceva and MetMAb here at ESMO,” said Richard Scheller, head of Genentech Research and Early Development, (gRED). “Lung cancer remains an area of high unmet medical need, and our new data with MetMAb is an example of how a targeted, personalized approach may help improve outcomes in this hard to treat disease.”
Preliminary results from a phase II study show that a combination of MetMAb, a unique monovalent antibody, with Tarceva (erlotinib) nearly doubled the time people with high MET expressing non-small cell lung cancer (NSCLC) lived without their disease getting worse (progression-free survival or PFS) compared to placebo plus Tarceva (HR=0.560, p=0.0547). The median PFS was improved from 6.4 weeks to 12.4 weeks.
The phase II, randomised, multicentre, double-blind, placebo-controlled study, presented at the European Society for Medical Oncology (ESMO) 2010, evaluated the activity and safety of MetMAb plus Tarceva, versus placebo plus Tarceva in patients who had received prior treatment for advanced NSCLC. Patients were stratified by the MET receptor expression in their tumour sample using immunohistochemistry (IHC), developed in collaboration with Ventana, a member of the Roche Group, and were categorised as MET-high or MET-low, according to a pre-defined scoring system.
The study also showed that as of the data cut date of June 8, 2010, the addition of MetMAb to Tarceva in patients whose tumours expressed high MET levels as assessed by IHC (50% or more of tumour cells staining at IHC intensity of 2+ or 3+) led to an improvement in overall survival (OS) compared to placebo plus Tarceva (HR=0.549 p=0.1113). The median OS was improved from 7.4 months to 7.7 months.
MetMAb treatment was generally well tolerated and no unexpected safety signals were observed. The MET-high population represented 54% of the patients enrolled in the study. The full analysis of the phase-II study will be presented at a medical meeting in the near future.
Tarceva first-line nearly triples PFS in NSCLC with EGFR activating mutations
Results from the phase III OPTIMAL study show that first-line Tarceva (erlotinib) extended the time people with a distinct form of lung cancer lived without their disease getting worse (progression free survival – PFS) to more than one year, which was almost three times longer than for patients who received traditional chemotherapy (median 13.1 vs. 4.6 months, HR=0.16, p<0.0001).
After one year over half (56%) of all Tarceva treated patients with advanced non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations were progression free compared to 1.7% of people who received chemotherapy. In addition, more than twice as many patients who received Tarceva experienced shrinkage of their tumours compared to those who received chemotherapy (83% vs. 36%; p < 0.00001).
Data from the OPTIMAL study will be shared with the European Medicines Agency to support the label extension currently under review for use of Tarceva as a first-line monotherapy treatment for people with advanced NSCLC with EGFR activating mutations.
Tarceva is the only EGFR inhibitor approved for use in maintenance and second-line treatment settings in patients with advanced or metastatic NSCLC irrespective of the presence of EGFR activating mutations.
A licence for Tarceva for use in the first-line setting would allow physicians to personalise early treatment according to EGFR activating mutation status, while people with NSCLC without EGFR activating mutations would continue to benefit from treatment with Tarceva in later lines of therapy.
As many as one in three (30%) Asian patients with lung cancer and an estimated one in ten (10%) lung cancer patients in the Western population have this distinct form of NSCLC.3,4
Tarceva is a once-daily, oral non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC.
MetMAb is a unique monoclonal monovalent antibody (one-armed antibody) that binds specifically to the cell surface MET receptor, blocking HGF-mediated activation.