About NP28673 About NP28761

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Caren Montgomery
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1 Media Release Basel, 14 May 2015 Roche s investigational medicine alectinib shrank tumours in nearly half of people with specific type of lung cancer Alectinib showed response rates of up to 69% in the central nervous system (CNS) in people with advanced ALK+ NSCLC Roche 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 Roche (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 inhibitor (ALKi), shrank tumours (overall response rate; ORR: 50% and 47.8%, respectively) in people with advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib. In addition, alectinib was shown to shrink tumours in people whose cancer had spread to the central nervous system (CNS) (CNS ORR: 57.1% and 68.8%, respectively). Additionally, people whose tumours 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% of people) were an increase in muscle enzymes (increased blood levels of creatine phosphokinase), increased liver enzymes and shortness of breath (dyspnea). 1,2 Cancer spreads to the brain in about half of people with ALK-positive lung cancer, and these studies suggest that alectinib can shrink tumours in people with this difficult-to-treat disease, said Sandra Horning, MD, 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 51 st 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 F. Hoffmann-La Roche Ltd 4070 Basel Switzerland Group Communications Roche Group Media Relations Tel Fax /5

2 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). 1,2 Alectinib was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in June 2013 for people with ALK+ 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 was made available in to patients in Japan in September 2014 and is marketed in Japan by Chugai Pharmaceutical, a member of the Roche Group. ALEX, a global randomised Phase III study, is ongoing, comparing alectinib to crizotinib as an initial (firstline) treatment for people with advanced NSCLC whose tumours were characterised as ALK+ by an investigational companion immunohistochemistry (IHC) test being developed by Roche. 3 About NP NP28673 is a phase I/II global, single arm, open-label, multicentre trial evaluating the safety and efficacy of alectinib in 138 people with ALK+ NSCLC whose disease progressed on crizotinib. The study showed by assessment of an independent review committee an ORR in 50.0% of people treated with alectinib, as measured by RECIST criteria. o An investigator assessment also showed tumours shrank in 47.8% of people who received alectinib. o CNS tumours shrank in response to alectinib in 57.1% of people whose disease had spread to the brain or other parts of the CNS. o In addition, the people whose tumours shrank in response to alectinib continued to respond for a median of 11.2 months (DOR, immature data). o 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. o The most common (occurring in at least 2% of people) Grade 3 or higher adverse event was shortness of breath (dyspnea; 4%). About NP NP28761 is a phase I/II North American, single arm, open-label, multicentre trial evaluating the safety and efficacy of alectinib in 87 people with ALK+ NSCLC whose disease progressed on crizotinib. 2/5

3 The study showed by assessment of an independent review committee an ORR in 47.8% of people treated with alectinib, as measured by RECIST criteria. o An investigator assessment showed tumours shrank in 46.0% of people who received alectinib. o CNS tumours shrank in response to alectinib in 68.8% of people whose disease had spread to the brain or other parts of the CNS. o In addition, the people whose tumours shrank in response to alectinib continued to respond for a median of 7.5 months (DOR, immature data). o The immature median PFS was 6.3 months (95% confidence interval [CI] 5.5 not estimable). Alectinib demonstrated a safety profile consistent with that observed in previous studies. o The most common (occurring in at least 2% of people) Grade 3 or higher adverse events were an increase in 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%). About Alectinib Alectinib (RG7853/AF-802/RO /CH ) is an investigational oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK+. ALK+ 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. Early studies with alectinib have shown activity on brain metastases, indicating that the drug may be taken up in the brain. The brain is protected by the Blood-Brain Barrier, a network of tightly joined cells that line the inside of the blood vessels in the brain and spinal cord. One of the ways the Blood-Brain Barrier prevents molecules from affecting the brain is to actively eject them from the barrier through a process known as active efflux. The active efflux system does not recognise alectinib, which means that it may travel into and throughout brain tissue. The Global Phase 3 studies of alectinib include a companion test developed by Roche. Alectinib is marketed in Japan by Chugai Pharmaceutical, a member of the Roche Group. About Roche in lung cancer Lung cancer is a major area of focus and investment for Roche, 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 3/5

4 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 Roche Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twentyeight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit roche.com. All trademarks used or mentioned in this release are protected by law. Additional information -Roche in Oncology: Roche Group Media Relations Phone: / basel.mediaoffice@roche.com - Nicolas Dunant (Head) - Ulrike Engels-Lange - Štěpán Kráčala - Nicole Rüppel 4/5

5 - Claudia Schmitt - Nina Schwab-Hautzinger 1 Ignatius Ou et al, Efficacy and safety of the ALK inhibitor alectinib in ALK+ non-small-cell lung cancer (NSCLC) patients who have failed prior crizotinib: an open-label, single-arm, global phase 2 study (NP28673) 2 Ghandi L et al, A phase 2, open-label, multicenter study of the ALK inhibitor alectinib in an ALK+ non-small-cell lung cancer (NSCLC) US/Canadian population who had progressed on crizotinib (NP28761) 3 (URL accessed: ) 5/5

FDA approves Roche s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer

Media Release Basel, 07 November 2017 FDA approves Roche s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer Approval based on phase III results that showed Alecensa