Roche's investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer

F. Hoffmann-La Roche Ltd / Roche's investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Entrectinib reduced tumours in people with ROS1-positive non-small cell lung cancer (NSCLC), including those whose disease had spread to the central nervous system (CNS)

Data will be submitted to global regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)

Basel, 24 September 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results for its investigational medicine entrectinib, from an integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA trials, which showed that entrectinib shrank tumours (objective response rate; ORR) in 77.4% of people with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).^[1] In addition, entrectinib demonstrated a durable response of more than two years (duration of response [DoR] = 24.6 months).^[1] Importantly, entrectinib was shown to shrink tumours in more than half of people with cancer in the central nervous system (CNS) (intracranial ORR: 55.0%).^[1] The safety profile of entrectinib was consistent with that seen in previous analyses, and no new safety signals were identified. ^[1] Based on the integrated analysis of these studies, Roche plans to submit these data to global health authorities.

"These results show the potential of precision medicines to deliver tailored and effective treatment options for people with non-small cell lung cancer, including those whose tumours have spread to the central nervous system," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "We are also investigating entrectinib in NTRK fusion-positive tumours across several different cancer types, and look forward to presenting those results in the near future."

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How gene targeting might transform the lives of patients with rare forms of lung cancer	Learn about entrectinib, a molecule being investigated for the potential treatment of certain ROS1- or NTRK-fusion positive cancer

ROS1 gene fusions have been identified in 1-2% of people with NSCLC. ^[2] NSCLC is the most common type of lung cancer and accounts for 85% of all lung cancer diagnoses. ^[3] Approximately 30-40% of people with ROS1-positive NSCLC have brain metastases at time of diagnosis. ^[4]