Analyst Outlook
Herceptin (trastuzumab; Roche/Chugai) is a monoclonal antibody (MAb) currently approved for the
first-line treatment of advanced or metastatic gastric cancer expressing human epidermal growth
factor receptor 2 (HER2). Herceptin was the first targeted therapy approved for gastric cancer, and has
since risen to become the standard of care for HER2-positive patients. Branded sales of Herceptin are
expected to come under threat from biosimilars as key patents protecting the drug’s exclusivity have
expired in Japan and the EU, with US patent expiry expected in 2019. Roche and Chugai are currently
developing Perjeta (pertuzumab; Genentech/Roche/Chugai), a distinct but complementary HER2-
targeted MAb, for use in combination with Herceptin. Perjeta’s development will be used to offset
biosimilar competition, and allow Roche and Chugai to retain their dominance in the HER2-positive
gastric cancer market. In addition, several studies have suggested Herceptin’s potential efficacy
beyond the first-line setting, and may serve the basis for future label expansion. These developments
will be critical for Herceptin’s continued success as the HER2 gastric cancer therapy of choice.
Drug Overview
Herceptin is a humanized MAb targeting the HER2 receptor, a member of the human epidermal
growth factor receptor family. HER2 expression promotes cell proliferation and suppresses apoptosis.
Overexpression of HER2 can facilitate uncontrolled growth and tumorigenesis (Boku, 2014). Herceptin
mediates antibody-dependent cellular cytotoxicity and has been shown in vitro to be preferentially
exerted on HER2-overexpressing cancer cells (Herceptin prescribing information, 2015). In vivo models
have also shown Herceptin’s ability to inhibit the proliferation of human tumor cells that overexpress
HER2 (Gravalos and Jimeno, 2008).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Herceptin : Gastric cancer
15 Herceptin : Breast cancer: HER2-positive
LIST OF FIGURES
6 Figure 1: Herceptin for gastric cancer – SWOT analysis
7 Figure 2: Datamonitor Healthcare’s drug assessment summary for Herceptin in gastric cancer
8 Figure 3: Datamonitor Healthcare’s drug assessment summary for Herceptin in gastric cancer
21 Figure 4: Herceptin – SWOT analysis in HER2-positive breast cancer
21 Figure 5: Datamonitor Healthcare’s drug assessment summary of Herceptin for HER2-positive
breast cancer
22 Figure 6: Datamonitor Healthcare drug assessment summary of Herceptin for HER2-positive
breast cancer
LIST OF TABLES
4 Table 1: Herceptin drug profile
6 Table 2: Herceptin pivotal trial data in gastric cancer
15 Table 3: Herceptin (trastuzumab; Roche/Chugai) – drug profile
18 Table 4: Overview of pivotal trial data for Herceptin in HER2-positive breast cancer