AstraZeneca PLC's Lung Cancer Drug Flunks Late-Stage Test
August 9, 2016
By Alex Keown, BioSpace.com Breaking News Staff
LONDON – Another late-stage lung cancer treatment has caused a setback for a drug company. This time AstraZeneca saw the failure of its Phase III combination drug of selumetinib and docetaxel chemotherapy failed to meet trial goals.
Shares of AstraZeneca are showing a slight decline this morning, following news that the combination dose did not have an overall impact on patients’ overall survival. However, the company anticipates the financial impact of the drug’s trial will be negligible, according to a company spokesperson who spoke with Bloomberg this morning. A big money-making drug is something AstraZeneca is looking for to meet its revenue goal of $45 billion in sales by 2023.
The drug was being used as a second-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). KRAS is one of the most common genetic mutations in NSCLC, and is found in 30 percent of patients. Selumetinib belongs to a class of drugs known as MEK inhibitors. That type of drug is used to inhibit mitogen-activated protein kinase enzymes MEK1 and/or MEK2.
An earlier mid-stage trial showed promising results for the treatment, but were not able to be confirmed in the Phase III trial. Sean Bohen, AstraZeneca’s chief medical officer said the company will present data from the trial at a future medical meeting.
Although the combination therapy failed, AstraZeneca said it was committed to developing lung cancer treatments that include immunotherapy and targeted EGFR treatments. AstraZeneca has other lung cancer treatments in its arsenal, including Tagrisso, which was approved in April. AstraZeneca also has hopes on another experimental lung cancer drug, durvalumab. There have been some setbacks for that drug, particularly in one trial when there were reports some patients developed interstitial lung disease-like problems. At the same time, different trial data has shown that a combination of durvalumab and tremelimumab has potential in treating tumors that have not traditionally responded to other immunotherapy treatments
Earlier this year selumetinib was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). AstraZeneca said it is committed to exploring the full potential of the drug, including Phase III trials in patients with DTC and in a U.S. National Cancer Institute-sponsored Phase II registration trial in patients with pediatric neurofibromatosis type 1, a genetic disorder that causes tumors to grow along nerve tissue.
AstraZeneca was hoping selumetinib would prove effective, particularly after rival Bristol-Myers Squibb reported its cancer drug Opdivo failed to meet its endpoints in a lung cancer trial. Opdivo, which has been approved for use against some cancers, was being studied in a Phase III trial as a monotherapy for a “broad patient population” in patients with previously untreated advanced non-small cell lung cancer.’
While the failure of selumetinib is not having a big impact on AstraZeneca stock, Array BioPharma Inc. , the company from which AstraZeneca acquired the drug in 2003, is seeing a negative impact. Shares of Array Biopharma are down nearly 20 percent this morning, trading at $3.57 per share as of 10:57 a.m. Array stood to earn milestone payments from the drug’s development and ultimate commercialization, Bloomberg noted.