Clinical data on KN026 in combination with docetaxel for neoadjuvant therapy for HER2-positive early or locally advanced breast cancer are published at SABCS 2022

Corning Jerry Biopharmaceuticals (stock code: 9966.
HK) announced that data from the Phase II clinical study of HER2 dual antibody KN026 in combination with docetaxel for neoadjuvant therapy for HER2-positive early or locally advanced breast cancer (study number: KN026-208) were presented
in poster form at the 2022 San Antonio Breast Cancer Congress (SABCS 2022).

Display form: poster

Poster topic: KN026 in combination with docetaxel for neoadjuvant therapy for HER2-positive early or locally advanced breast cancer: a single-arm, multicenter, phase II study

Poster number: OT2-16-04

Corresponding author: Professor Wu Jiong, Cancer Hospital of Fudan University

Published: December 7, 2022, 5:00- 6:15pm (CST)

KN026-208 (NCT04881929) is a phase II, open-label, multicenter clinical study to evaluate the efficacy, safety, and tolerability
of KN026 in combination with docetaxel in neoadjuvant therapy for HER2-positive early/locally advanced breast cancer.
The patient received KN026 30mg/kg Q3W combined with docetaxel 75mg/m2 Q3W for 4 cycles before surgery
.
The primary endpoint of the study was overall pathologic complete response rate (tpCR rate); Secondary endpoints were complete response rate (bpCR rate), objective response rate (ORR), safety, pharmacokinetics (PK), and immunogenicity
.

As of September 10, 2022, a total of 30 women with HER2-positive early or locally advanced breast cancer were enrolled in the study, of which 20 patients completed surgery and postoperative pathological evaluation
。 The overall pathologic complete response (tpCR) rate was 50.
0% (10/20, 95% CI: 27.
2% to 72.
8%), the breast pathologic complete response (bpCR) rate was 55.
0% (11/20, 95% CI: 31.
53% to 76.
94%), and the objective response rate (ORR) was 100% (20/20, 95% CI: 83.
16% to 100%)
.

In terms of safety, 16 of the 30 patients (53.
3%) experienced grade 3 and above adverse events (TEAEs), and the most common (incidence ≥5%) were neutropenia (50%, 15/30), decreased white blood cell count (40%, 12/30) and decreased lymphocyte count (10%, 3/30).

The incidence of serious adverse events (SAEs) and grade 3 and above SAEs was 6.
7% (2/30).

There was only one case
of SAE related to KN026 and SAE related to docetaxel.

The results showed that KN026 combined with docetaxel neoadjuvant therapy had significant efficacy and was well tolerated in patients with early or locally advanced
HER2-positive breast cancer.

About KN026

KN026 is a HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights, which can bind two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade, which is better than the combination of trastuzumab and pertuzumab, such as showing higher affinity, and has a potent tumor suppressor effect in HER2-positive tumor cell lines
.
At the same time, KN026 also has inhibitory effect
on HER2 low-expression tumors and trastuzumab-resistant cell lines.

KN026 has been approved by the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) in 2018, and is currently conducting a number of clinical trials in different stages in China and the United States, including breast cancer, gastric cancer/gastroesophageal junction cancer, etc.
, KN026 combined with chemotherapy and KN026 combined with KN046 no chemotherapy for gastric cancer
。 The trial results showed that KN026 had good efficacy and safety, and still showed significant antitumor activity
in patients with HER2-positive breast cancer who progressed after multi-line anti-HER2 therapy.

In August 2021, Corning Jereh signed a Chinese mainland development and commercialization license agreement
with Shanghai Jinmante Biotechnology Co.
, Ltd.
(hereinafter referred to as "Jinmante Biotechnology"), a wholly-owned subsidiary of CSPC Pharmaceutical Group.
According to the terms of the agreement, Zimante Biotech will obtain the exclusive development and exclusive commercialization license of KN026 in Chinese mainland (excluding Hong Kong, Macau and Taiwan) for breast cancer and gastric cancer indications
.