Genentech Lung Cancer Treatments Shrink Tumors, Prolong Life
Published: May 15, 2015
May 14, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SOUTH SAN FRANCISCO – Two Genentech studies revealed its investigational oral drug alectinib, an anaplastic lymphoma kinase (ALK) inhibitor, shrank tumors in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib.
The two studies showed the tumors shrank by 50 percent and 47.8 percent, respectively. Additionally, results from the two studies showed alectinib was able to shrink tumors in people whose cancer had spread to the central nervous system by 57.1 percent and 68.8 percent respectively, the company said. The shrinking of tumors prolonged life in trial patients who took the medication.
The patients continued to respond for a median of 11.2 and 7.5 months, respectively. The results of the studies will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology at the end of this month.
Because of the positive results of the two trials, Genentech said it will submit the data to federal regulators later this year to support approval of alectinib as a new option for patients whose advanced ALK-positive lung cancer continued to progress on crizotinib. Developed by Pfizer Inc. , crizotinib was approved by the U.S. Food and Drug Administration (FDA) in 2013 for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.
“Cancer spreads to the brain in about half of people with ALK-positive lung cancer, and these studies suggest that alectinib can shrink tumors in people with this difficult-to-treat disease,” Sandra Horning, Genentech’s head of Global Product Development, said in a statement.
According to the American Cancer Society, approximately 221,000 Americans will be diagnosed with lung cancer this year, with about 60 percent of those diagnoses being made when the disease is in advanced stages. NSCLC accounts for 85 percent of all lung cancers, according to the ACS. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history. It is almost always found in people with a specific type of NSCLC called adenocarcinoma, the company said.
Genentech has two approved medicines to treat certain kinds of lung cancer, including Avastin, and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.
Alectinib was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.
Alectinib is currently undergoing a Phase III trial, dubbed Alex, which is comparing Genentech’s drug to crizotinib as a first-line treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by an investigational companion immunohistochemistry test, which was developed by Genentech’s parent company Roche .
In addition to the investigational studies for alectinib, Genentech also announced that an experimental drug with the code MPDL3280A showed the immunotherapy doubled the likelihood of survival vs. chemotherapy in people with previously treated, advanced NSCLC whose cancer had the highest levels of PD-L1. MPDL3280A is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells.
“The goal of PD-L1 as a biomarker is to identify people most likely to experience improved overall survival with MPDL3280A alone, and which people may be appropriate candidates for a combination of medicines,” Horning said.
In February, MPDL3280A received Breakthrough Therapy Designation from the FDA for the treatment of patients with NSCLC that expresses PD-L1 and who progressed during or after standard treatments.
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