sacibertinib (Hemay022) / Tianjin Hemay Pharma - LARVOL DELTA

A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=339 | Recruiting | Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd

Combination therapy • Metastases • New P3 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

A phase I study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer. (PubMed, Chin J Cancer Res) - P3 | "The pharmacokinetic properties and encouraging anti-tumor activities of Hemay022 in advanced breast cancer patients warranted further evaluation of Hemay022 for treating breast cancer patients in the current phase III trial (No. NCT05122494)."

Journal • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • EGFR • HER-2

Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd | Recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Study Evaluating Hemay022 In Subjects With HER2-Positive Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd | Unknown status ➔ Completed | N=57 ➔ 28 | Trial completion date: Dec 2018 ➔ Sep 2023 | Trial primary completion date: Dec 2018 ➔ Sep 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Sacibertinib Plus Endocrine Therapy Shows Early Safety, Activity in ER+/HER2+ Breast Cancer (OncLive) - P1 | N=57 | NCT02476539 | "Sacibertinib (Hemay022) plus endocrine therapy demonstrated acceptable safety with early clinical activity in patients with estrogen receptor (ER)–positive/HER2-positive metastatic breast cancer, according to data from a phase 1b study (NCT02476539) presented at the 2023 San Antonio Breast Cancer Symposium. In the 51 patients total patients, the overall response rate was 31.4%; this was comprised of a complete response (CR) rate of 2.0%, a partial response (PR) rate of 29.4%, and a stable disease (SD) rate of 51.0%; 17.6% of patients experienced progressive disease (PD). Moreover, the disease control rate (DCR) was 82.4%, and the clinical benefit rate (CBR) was 60.8%."

P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Antitumor activity and safety of sacibertinib (Hemay022) in combination with endocrine therapy in patients with ER and HER2 both positive metastatic breast cancer: A phase Ib study (SABCS 2023) - "This study aimed to explore the safety and efficacy of sacibertinib plus endocrine therapy in patients with estrogen receptor-positive ( PATIENTS AND METHODS Using a phase 1b 3+3 dose escalation and expansion study design, patients with ER+/ HER2+ MBC were treated with sacibertinib (200mg-500mg daily) plus endocrine therapy including exemestane, letrozole, fulvestrant. CONCLUSION Sacibertinib plus endocrine therapy had a favorable safety profile and antitumor activity in patients with ER+/ HER2+ MBC, 400-500mg daily showed more efficacy, supporting further assessment in randomized studies. This figure showed response of Sacibertinib plus endocrine therapy in ER+/ HER2+ metastatic breast cancer."

Clinical • Combination therapy • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Antitumor efficacy and safety of sacibertinib (Hemay022) in combination with endocrine therapy in patients with ER+ and HER2+ metastatic breast cancer: A phase Ib study (SABCS 2023) - P1 | "PATIENTS AND METHODS Using a phase 1b 3+3 dose escalation and expansion study design, patients with ER+/ HER2+ MBC were treated with sacibertinib (200mg-500mg daily) plus endocrine therapy including exemestane, letrozole, fulvestrant . Summary of efficacy data(EAS) NOTE. NA, not available (because cannot be calculated) Treatment-Emergent Adverse Events Occurring in ≥ 10% of Patients in the Safety Population Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; Waterfall plot of best change rate in target-lesion size from baseline"

Clinical • Combination therapy • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Phase Ⅲ Study of the Efficacy and Safety of Hemay022+Aromatase Inhibitor(AI) in Participants With ER+/HER2+ Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=339 | Recruiting | Sponsor: Tianjin Hemay Oncology Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Phase Ⅲ Study of the Efficacy and Safety of Hemay022+Aromatase Inhibitor(AI) in Participants With ER+/HER2+ Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P3; N=339; Not yet recruiting; Sponsor: Tianjin Hemay Oncology Pharmaceutical Co., Ltd

Clinical • New P3 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Tianjin Hemay Pharmaceutical Co.,Ltd; Trial completion date: Jul 2021 ➔ Dec 2022; Trial primary completion date: Feb 2021 ➔ May 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Food-Effect Study of Hemay022 in Healthy Participants (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Tianjin Hemay Oncology Pharmaceutical Co., Ltd; Trial primary completion date: Dec 2020 ➔ May 2021

Clinical • Trial primary completion date

A Food-Effect Study of Hemay022 in Healthy Participants (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Tianjin Hemay Oncology Pharmaceutical Co., Ltd

Clinical • New P1 trial

Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Tianjin Hemay Pharmaceutical Co.,Ltd; Trial completion date: Jul 2019 ➔ Jul 2021; Trial primary completion date: Mar 2019 ➔ Feb 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2