Roche Pharmaceutical Development and Sales Overview

Gavreto (pralsetinib, RG6396) Highly selective RET inhibitor Indication Phase/study # of patients Design " RET+ NSCLC, thyroid cancer and other advanced solid tumors Phase I/II ARROW N=647 Part I: Gavreto 30-600mg dose escalation Part II: Gavreto 400mg dose expansion Primary endpoint ■ Status " ■ Safety and efficacy Data presented at ASCO (NSCLC) and ESMO (MTC) 2020 Filed in US and EU for RET fusion-positive NSCLC and US for RET-mutant MTC and RET fusion-positive thyroid cancer Approved in US Q3 2020 in RET fusion-positive NSCLC, in Q4 2020 in RET- mutant MTC and RET fusion-positive thyroid cancer Updated data presented at ASCO 2021 and 2022 Data published in Lancet Oncol 2021 Jul;22(7):959-969 and Lancet Diabetes & Endocrinology Aug 2021;9(8):491-501 Approved in EU for RET fusion-positive NSCLC Q4 2021 CT Identifier NCT03037385 1L RET fusion-positive, metastatic NSCLC Phase III AcceleRET Lung N=250 " ARM A: Gavreto 400mg ◉ ARM B: Platinum-based chemotherapy +/- pembrolizumab Progression-free survival Study initiated in Q1 2020 NCT04222972 In collaboration with Blueprint Medicines NSCLC-non-small cell lung cancer; MTC-medullary thyroid cancer; RET=Rearranged during transfection; ASCO=American Society of Clinical Oncology; ESMO-European Society for Medical Oncology Roche 79 Oncology

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