Roche's investigational personalised medicine entrectinib shrank tumours in people with NTRK fusion-positive solid tumours

F. Hoffmann-La Roche Ltd / Roche's investigational personalised medicine entrectinib shrank tumours in people with NTRK fusion-positive solid tumours . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Entrectinib showed response irrespective of tumour type or 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, 21 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from an integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials that showed the investigational personalised medicine entrectinib shrank tumours (objective response rate; ORR) in more than half (57.4%) of people with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive solid tumours. Objective responses to entrectinib were seen across ten different solid tumour types (median duration of response [DOR]=10.4 months), including in people with and without central nervous system (CNS) metastases at baseline. [1] Importantly, entrectinib shrank tumours that had spread to the brain in over half of people (intracranial response; IC ORR=54.5%), with more than a quarter of these people having a complete response. [1] The safety profile of entrectinib was consistent with that seen in previous analyses. [1]

"These data demonstrate the potential of entrectinib to treat a range of difficult-to-treat and rare cancers regardless of their site of origin," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "Entrectinib has the potential to redefine personalised medicine, which can utilize tests such as next-generation sequencing, to find the right treatment for each individual patient. People with NTRK fusion-positive solid tumours need more options, and we look forward to working with health authorities to bring this potential treatment to patients as soon as possible."