AstraZeneca Presents Tagrisso Leptomeningeal Disease Data

AstraZeneca plc (NYSE:AZN) presented clinical and safety data from a phase I study (BLOOM) on its lung cancer drug, Tagrisso (osimertinib), in patients with leptomeningeal (LM) disease at the annual meeting of the American Society of Clinical Oncology.

Updated results showed that Tagrisso (160 mg once daily) demonstrated activity through assessments with MRI imaging intracranial response irrespective of the T790M mutation status of patients. Additionally, Tagrisso crossed the blood-brain barrier. The drug resulted in a decline in central nervous system lesions in patients with LM disease in addition to neurological improvement. Moreover, Tagrisso demonstrated a manageable tolerability profile over a treatment period of up to 11 months.

Per the company’s press release, LM disease is a complication of epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC), where cancer cells spread to the cerebrospinal fluid. LM disease affects roughly 5% of patients with NSCLC and nearly 9% of those with EGFRm NSCLC.

Considering that the treatment of LM disease is difficult, the safety, tolerability and activity profile that Tagrisso has demonstrated is promising.

We note that Tagrisso (80 mg once daily) gained accelerated approval in Nov 2015 for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy. It is also approved for the treatment of patients with EGFR T790M mutation-positive locally advanced/metastatic NSCLC in the EU.

Currently, Tagrisso is also being evaluated in the adjuvant setting and in the metastatic first-line setting, including patients with brain metastases, as well as in combination with other treatments.

AstraZeneca is working on strengthening its oncology product portfolio and has several candidates in its pipeline. The company’s target is to launch at least six new medicines between 2014 and 2020.

AstraZeneca is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) , Retrophin, Inc. (NASDAQ:RTRX) and Bristol-Myers Squibb Company (NYSE:BMY) . All three stocks sport a Zacks Rank #1 (Strong Buy).