Meeting
2023 ASCO Annual Meeting
Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy (1L) for patients (pts) with advanced HER2-positive breast cancer (BC): Updated results from a phase 1b/2 study.
Authors
Xiaojia Wang
Department of Oncology, Zhejiang Cancer Hospital, Hangzhou, China
Xiaojia Wang , Keun Seok Lee , Xiaohua Zeng , Tao Sun , Young-Hyuck Im , Huiping Li , Kun Wang , Huiyan Li , Ping Zhou , Yuanyuan Bao , Zefei Jiang
Organizations
Department of Oncology, Zhejiang Cancer Hospital, Hangzhou, China, Department of Oncology, National Cancer Center, Goyang-Si, Korea, Republic of (South), Department of Breast Oncology, Chongqing University Cancer Hospital, Chongqing, China, Breast Medicine, Cancer Hospital of China Medical University, Liaoning Cancer Hospital, Liaoning, China, Department of Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of (South), Department of Breast Oncology, Beijing Cancer Hospital, Beijing, China, Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China, Clinical Development, BeiGene (Shanghai) Co., Ltd., Shanghai, China, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China
Research Funding
Pharmaceutical/Biotech Company
BeiGene, Ltd., This study was sponsored by BeiGene, Ltd. Medical writing support for the development of this abstract, under the direction of the authors, was provided by Emily Finn, MSc, of Ashfield MedComms, an Inizio company, and was funded by BeiGene, Ltd
Background: Despite HER2-targeted agents improving outcomes in HER2-positive (+) BC, some pts develop resistance, relapse, or do not respond to current 1L therapies. Zani, also known as ZW25, is a novel HER2-targeted bispecific antibody that binds to two distinct extracellular domains of HER2. Preliminary results from this phase 1b/2 trial (NCT04276493) showed that zani plus docetaxel had a manageable safety profile and demonstrated promising antitumor activity in pts with advanced HER2+ BC; here we present the updated data following enrollment completion. Methods: Cohort 1 of this open-label study is evaluating zani in combination with docetaxel as a 1L therapy in adult females with advanced HER2+ BC who may have received prior neoadjuvant/adjuvant therapy. Cohort 1a pts received zani 30 mg/kg intravenously (IV), Cohort 1b pts received zani 1800 mg IV, both with docetaxel 75 mg/m2 IV every 3 weeks. The primary endpoints were safety and investigator (INV)-assessed objective response rate (ORR) per RECIST v1.1. Secondary endpoints included INV-assessed duration of response (DoR) and disease control rate (DCR). Results: As of Nov 22, 2022, 37 pts (median age 55.0 years [range: 33-80]) were assigned to Cohort 1a (n=10) or 1b (n=27). Median study follow-up was 15.5 months (range: 1.1-29.3); patients received a median of 13 treatment cycles (range 1-37) and 18 (48.6%) pts remained on treatment. Of the 33 efficacy evaluable (EE) pts, confirmed ORR was 90.9% (95% confidence interval [CI]: 75.7, 98.1). Efficacy data are summarized in Table. In total, 36 (97.3%) pts experienced ≥1 treatment-related adverse event (TRAE); 25 (67.6%) pts experienced ≥grade 3 TRAEs. The most common ≥grade 3 TRAEs were decreased neutrophil count, experienced by 18 (48.6%) pts, and decreased white blood cell count, experienced by 7 (18.9%) pts. Serious TRAEs occurred in 6 (16.2%) pts; no TRAEs led to death. Conclusions: Zani combined with docetaxel demonstrated promising antitumor activity as 1L therapy for advanced HER2+ BC, with a manageable safety profile. Clinical trial information: NCT04276493.
| Cohort 1a (n=8) | Cohort 1b (n=25) | Total (n=33) | |
|---|---|---|---|
| Confirmed best overall response, n (%) | |||
| Complete response | 1 (12.5) | 1 (4.0) | 2 (6.1) |
| Partial response | 7 (87.5) | 21 (84.0) | 28 (84.8) |
| Stable disease | 0 (0.0) | 2 (8.0) | 2 (6.1) |
| Progressive disease | 0 (0.0) | 1 (4.0) | 1 (3.0) |
| Confirmed ORR, n (%) 95% CI | 8 (100) 63.1, 100 | 22 (88.0) 68.8, 97.5 | 30 (90.9) 75.7, 98.1 |
| Confirmed DCR, n (%) 95% CI | 8 (100) 63.1, 100 | 24 (96.0) 79.6, 99.9 | 32 (97.0) 84.2, 99.9 |
| Median DoR, months (95% CI) | 12.4 5.5, NE | NE 12.1, NE | NE 12.1, NE |
| Confirmed DoR, range† | 3.5†-23.5† | 4.3†-16.5† | 3.5†-23.5† |
*Four pts without any postbaseline tumor assessments were excluded from the EE analysis set.
Data cut off: November 22, 2022.
†Censored.
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Abstract Details
Session Type
Poster Session
Session Title
Breast Cancer—Metastatic
Track
Breast Cancer
Sub Track
HER2-Positive
Clinical Trial Registration Number
NCT04276493
Citation
J Clin Oncol 41, 2023 (suppl 16; abstr 1044)
DOI
10.1200/JCO.2023.41.16_suppl.1044
Abstract #
1044
Poster Bd #
265
Abstract Disclosures
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