Athenex, Inc. (ATNX announced that it has completed target enrollment of 360 patients in the Oraxol phase III study in metastatic breast cancer on schedule. Athenex also reaffirmed that top-line data from the study is expected to be available in mid-2019.
Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy combined with HM30181A (a novel gastrointestinal tract specific P-glycoprotein pump inhibitor). The Oraxol phase III study is an open label study, which will evaluate the safety, tolerability and tumor response of Oraxol compared with IV paclitaxel in patients with metastatic breast cancer. Secondary endpoints will measure progression-free survival and overall survival.
In October 2018, the company reported encouraging efficacy and safety data of Oraxol in the treatment of metastatic breast cancer patients obtained from a phase II study conducted in Taiwan. Results from twenty-four patients with metastatic breast cancer were reported.
Eleven patients (45.8%) achieved partial remission (PR), 10 patients (41.7%) had stable disease (SD) and 3 patients had progressive disease (PD). Drug-related serious adverse events consisting of Grade 4 neutropenia were observed in 3 patients and all recovered completely. There was no dose limiting neuropathy observed. Oraxol is one of the lead candidates in the company’s pipeline and a potential approval will boost the company’s top line.
Shares of Athenex decreased 21.6% in the past year, compared with the industry’s decline of 19.5%.
Athenex is a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer through its Orascovery and Src Kinase Inhibition research platforms.
The breast cancer market is crowded and a lot of companies are developing drugs to combat this disease. In December 2018, Roche RHHBY announced that its breast cancer drug, Kadcyla significantly reduced the risk of disease recurrence by 50% as an adjuvant (after surgery) therapy in phase III KATHERINE study compared to its other breast cancer drug, Herceptin.
The late-stage KATHERINE study compared Kadcyla with Herceptin for risk of disease recurrence or death in HER2-positive early breast cancer patients with residual disease following a neoadjuvant (before surgery) therapy. Back in October, Roche announced that the study had met its primary endpoint of reduction in disease recurrence.
Kadcyla, an antibody-drug conjugate, is approved as monotherapy in second-line setting for treating metastatic breast cancer in patients who have received treatment with Herceptin or/and taxane since 2013.
In December 2018, Puma Biotechnology, Inc. PBYI announced positive top-line results from the phase III NALA study, evaluating its only marketed drug, Nerlynx (neratinib) for the treatment of third-line hormone receptor-positive (HER2-positive) metastatic breast cancer.
Pfizer PFE also has Xtandi in its portfolio, which is in mid-stage development for advanced breast cancer.
Athenex currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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