Biotech Values

[BTH]

From ARRY today:

Also, AstraZeneca recently announced a potential start of a Phase 3 trial with selumetinib in non-small cell lung cancer (NSCLC) during the second half of 2013.

Selumetinib – AstraZeneca may initiate Phase 3 trial in 2013

AstraZeneca recently announced with their quarterly financial results that they expect to initiate a Phase 3 selumetinib trial in 2013 in patients with NSCLC. Selumetinib is advancing in 65 trials, 39 of which are in Phase 2. AstraZeneca initiated a 225-patient Phase 2 randomized trial with selumetinib in combination with docetaxel in 2nd line unselected NSCLC. The trial will evaluate two different doses of docetaxel with selumetinib versus docetaxel alone. We believe this will help optimize the product's profile, validate biomarker diagnostics and generate preliminary efficacy in selective subsets of NSCLC patients. Additionally, AstraZeneca will specifically assess efficacy within KRAS subgroups in terms of progression free survival, overall survival, overall response rate and change in tumor size at week 6.

In addition to NSCLC, positive results were presented last year with selumetinib in thyroid and ovarian cancers. In a Phase 2 trial in recurrent low-grade serous ovarian or peritoneal cancer, patients taking selumetinib showed a disease control rate of 81%, defined as either complete or partial response or progression-free survival or progression-free survival of greater than 6 months. Eight patients had complete (1) or partial (7) responses. The median survival rate without cancer progression was 11 months. And in patients with thyroid cancer, selemetinib showed a 71% partial response and 91% mean reduction in tumor growth. In this study, selumetinib resensitized patients to radioactive iodine to warrant further therapy.