Wednesday, May 13, 2015

Genentech’s Investigational Medicine Alectinib Shrank Tumors in Nearly Half of People with Specific Type of Lung Cancer

• Alectinib showed response rates of up to 69 percent in the central nervous system (CNS) in people with advanced ALK-positive non-small cell lung cancer
• Genentech plans to submit these Phase I/II data to the FDA as part of a New Drug Application for alectinib, which has been granted Breakthrough Therapy Designation

South San Francisco, CA -- May 13, 2015 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from two pivotal studies (NP28673 and NP28761) that showed alectinib, its oral investigational anaplastic lymphoma kinase (ALK) inhibitor, shrank tumors (overall response rate; ORR: 50.0 percent and 47.8 percent, respectively) in people with advanced ALK-positive non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib. In addition, alectinib was shown to shrink tumors in people whose cancer had spread to the central nervous system (CNS) (CNS ORR: 57.1 percent and 68.8 percent, respectively). People whose tumors shrank in response to alectinib continued to respond for a median of 11.2 and 7.5 months, respectively (duration of response; DOR). Alectinib demonstrated a safety profile consistent with that observed in previous studies. The most common adverse events (Grade 3 or higher occurring in at least 2 percent of people) were an increase in muscle enzymes (increased blood levels of creatine phosphokinase), increased liver enzymes and shortness of breath (dyspnea).   

"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," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We plan to submit these data to the FDA this year to support alectinib as a potential new option for people whose advanced ALK-positive lung cancer progressed on crizotinib." 

Results from both studies will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO). The NP28673 study will be presented by Dr. Sai-Hong Ignatius Ou, associate clinical professor, University of California, Irvine (Abstract #8008, Sunday, May 31, 10:24-10:36 A.M. CDT), and the NP28761 study will be presented by Dr. Leena Gandhi, assistant professor of medicine, Dana-Farber Cancer Institute, Boston (Abstract #8019, Monday, June 1, 8:00-11:30 A.M. CDT). 

Alectinib was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) 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.

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

About the NP28673 Study 

• NP28673 is a Phase I/II 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. 
• The study showed by assessment of an independent review committee an ORR in 50.0 percent of people treated with alectinib, as measured by RECIST criteria. 
  • An investigator assessment also showed tumors shrank in 47.8 percent of people who received alectinib.
  • CNS tumors shrank in response to alectinib in 57.1 percent of people whose disease had spread to the brain or other parts of the CNS.
  • In addition, the people whose tumors shrank in response to alectinib continued to respond for a median of 11.2 months (DOR, immature data).
  • The median progression-free survival (PFS) for people who received alectinib was 8.9 months. 
• Alectinib demonstrated a safety profile consistent with that observed in previous studies.
  • The most common (occurring in at least 2 percent of people) Grade 3 or higher adverse event was shortness of breath (dyspnea; 4 percent).

About the NP28761 Study 

• NP28761 is a Phase I/II 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. 
• The study showed by assessment of an independent review committee an ORR in 47.8 percent of people treated with alectinib, as measured by RECIST criteria.
  • An investigator assessment showed tumors shrank in 46.0 percent of people who received alectinib.
  • CNS tumors shrank in response to alectinib in 68.8 percent of people whose disease had spread to the brain or other parts of the CNS.
  • In addition, the people whose tumors shrank in response to alectinib continued to respond for a median of 7.5 months (DOR, immature data).
  • The immature median PFS was 6.3 months (95 percent confidence interval [CI] 5.5–not estimable). 
• Alectinib demonstrated a safety profile consistent with that observed in previous studies.
  • The most common (occurring in at least 2 percent of people) Grade 3 or higher adverse events were an increase in muscle enzymes (increased blood levels of creatine phosphokinase; 8 percent), increased liver enzymes (alanine aminotransferase; 6 percent, and aspartate aminotransferase; 5 percent) and shortness of breath (dyspnea; 3 percent).

About Alectinib

Alectinib (RG7853/AF-802/RO5424802/CH5424802) is an investigational oral medicine created at Chugai Kamakura Research Laboratories and is being developed for 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. It is almost always found in people with a specific type of NSCLC called adenocarcinoma.

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. 

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.

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