Tuesday, Sep 8, 2015

FDA Grants Genentech's Alectinib Priority Review for Specific Type of ALK-Positive Lung Cancer

South San Francisco, CA -- September 8, 2015 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Alectinib was granted Breakthrough Therapy Designation by the FDA in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib.

“Alectinib was granted Priority Review by the FDA based on results from two studies showing the medicine shrank tumors in people with ALK-positive NSCLC that progressed on crizotinib,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “There is a need for new treatment options in this patient population, especially because the disease often spreads to the brain at progression.”

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The NDA for alectinib includes data from two Phase II studies (NP28761 and NP28673), and the FDA will make a decision on approval by March 4, 2016.

ALEX, an ongoing, global randomized Phase III study is comparing alectinib to crizotinib as an initial (first-line) treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion immunohistochemistry (IHC) test developed by Roche Diagnostics.

About the NP28761 and NP28673 Studies

Results from the Phase II NP28761 and NP28673 studies were recently presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO).

• NP28761 is a North American, single-arm, open-label, multicenter trial evaluating the safety and efficacy of alectinib in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib.
  • Response assessment by an independent review committee (IRC) showed that alectinib shrank tumors (objective response rate, ORR) in 47.8 percent (95 percent confidence interval [CI] 35.6 percent-60.2 percent) of people treated with alectinib, as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  • Investigator assessment showed that alectinib shrank tumors in this group of people with a similar response rate (ORR of 46.0 percent, [95 percent CI 35.2 percent-57.0 percent]).
  • Activity was also observed in the central nervous system (CNS), as shown by a CNS ORR by IRC of 68.8 percent (95 percent CI 41.3 percent-89.0 percent) in people whose disease had already spread to the brain or other parts of the CNS at study entry.
  • People whose tumors shrank in response to alectinib continued to respond for a median of 7.5 months (duration of response [DOR], immature data).
  • The immature median progression-free survival (PFS) was 6.3 months (95 percent CI 5.5 months–not estimable) based on 40 percent of events.

• In study NP28761, alectinib demonstrated a safety profile consistent with that observed in previous studies.
  • The most common Grade 3 or higher adverse events were increased muscle enzymes (increased blood levels of creatine phosphokinase; 8%), increased liver enzymes (alanine aminotransferase; 6%, and aspartate aminotransferase; 5%) and shortness of breath (dyspnea; 3%).
• NP28673 is a global, single-arm, open-label, multicenter trial evaluating the safety and efficacy of alectinib in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib.
  • An IRC analysis showed that alectinib shrank tumors (ORR of 50.0 percent, [95 percent CI 40.8 percent-59.1 percent]) in this group of people, as measured by RECIST.
  • Assessment by investigator was consistent with the IRC and also showed that alectinib shrank tumors in this group of people (ORR of 47.8 percent, [95 percent CI 39.3 percent-56.5 percent]).
  • Activity was also observed in the CNS, as shown by a CNS ORR by IRC of 57.1 percent (95 percent CI 39.4 percent-73.7 percent) in people whose disease had already spread to the brain or other parts of the CNS at study entry.
  • People who achieved a response continued to respond for a median of 11.2 months (DOR, immature data based on 33 percent of events, [95 percent CI 9.6 months-not estimable]).
  • The median PFS for people who received alectinib was 8.9 months (95 percent CI 5.6 months-11.3 months) based on 58 percent of events.
• Alectinib demonstrated a safety profile in study NP28673 consistent with that observed in previous studies.
  • The most common Grade 3 or higher adverse event was shortness of breath (dyspnea; 4%).

About alectinib

Alectinib (RG7853/AF-802/RO5424802/CH5424802) is an oral medicine created at Chugai Kamakura Research Laboratories for certain people with NSCLC whose tumors are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.

About Lung Cancer

According to the American Cancer Society, it is estimated that more than 221,000 Americans will be diagnosed with lung cancer in 2015, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages. Approximately 5 percent of people with NSCLC in the United States are ALK-positive.

About Genentech in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have two approved medicines to treat certain kinds of lung cancer 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.

About Genentech

Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.