GQ-1005

From September 7 to September 10, 2024, the World Congress on Lung Cancer (WCLC) was held in San Diego, USA. WCLC is one of the most influential academic events in the field of lung cancer, where top experts and scholars from all over the world share and discuss the latest cutting-edge developments. On September 10, local time, GeneQuantum released the latest data of the first human study (FIH) of a novel HER2-ADC GQ1005 in HER2-expressing or HER2- mutated advanced solid tumors in the form of an oral report at the conference. As of the data cut-off on May 10th, 188 patients were enrolled, including 50 patients with NSCLC. The median age of the whole population is 55 years old, and 54.8% of patients have received third-line or above treatments in the past, and the median drug exposure were 84 days. The median age of the NSCLC subgroup is 58 years old, and 52% of patients have received at least second-line treatments in the past, and the median drug exposure exposure were 85 days. GQ1005 has excellent safety and tolerance: Lower rates of gastrointestinal toxicity, hepatotoxicity and hematotoxicity than benchmark in whole population and NSCLC. ≥G3 TRAEs were less than 20% (17.6% and 14.0% in whole population and NSCLC, respectively). The most common ≥G3 TRAEs (incidence ≥2%) in whole population are lymphocyte count decreased (4.3%) and anemia (3.7%). The most common ≥G3 TRAEs (incidence ≥2%) in NSCLC are vomiting (4%), nausea (4%), anemia (2%), decreased appetite (2%), platelet count decreased (2%), fatigue (2%), and lymphocyte count decreased (2%). Lower incidence of ILD in whole population and NSCLC. Most of them were grade 1-2 and recovered. GQ1005 shows promising antitumor activity： Among the whole population, the objective response rate (ORR) of 154 assessable patients was 40.9%, and the disease control rate (DCR) was 83.8%. In NSCLC, the ORR of 40 evaluable patients was 32.5% and the DCR was 92.5%. The median follow-up time was 4.5 months and 5.49 months in whole population and NSCLC, respectively. The median progression-free survival (mPFS) was 7.23 months, and the median duration of response (mDoR) was 8.8 months in whole population and NSCLC The 12-month OS rate all beyond 70% in both targeted population, 72.6% and 73.4% respectively. Dr. Shi Yan, Chief Medical Officer of GeneQuantum, said:“We are very happy to share the latest research data of GQ1005 in the form of an oral report at the WCLC conference. GQ1005 is a new generation of HER2 ADC independently developed by GeneQuantum, which has shown encouraging safety and clinical benefits in a variety of advanced solid tumors expressed by HER2. Although the number of NSCLC in the current study is small and the follow-up time is still short, it has also shown positive efficacy signals and excellent safety characteristics, which is enough to stimulate interest in further exploration. We will continue to promote the research and exploration of GQ1005 in a variety of solid tumors with HER2 expression/mutation, and bring new treatment options to more patients.” About GQ1005 GQ1005 is an innovative anti-HER2 antibody-drug conjugate (ADC) developed by GeneQuantum. The antibody is an engineered trastuzumab targeting HER2, and the payload is a topoisomerase I inhibitor, DXd. GQ1005 was produced using a unique immobilized enzyme-based site-specific conjugation platform, leading to higher homogeneity and purity. This ADC features a highly stable linker and has a bystander killing effect. Preclinical studies have shown that GQ1005 exhibits similar antitumor efficacy to Enhertu and better stability than Enhertu, with a notable absence of toxicity, suggesting a superior therapeutic profile. At present, GQ1005 has been approved to carry out phase III clinical trials for the treatment of HER2-positive non-surgical resection/metastatic breast cancer. About GeneQuantum Healthcare GeneQuantum, headquartered in China, is a global leader in the ADC field, distinguished for its advancement of enzymatic site-specific conjugation technologies. GQ’s pioneering technologies, iLDC and iGDC, serve as the foundation of a comprehensive ADC drug development platform, spanning from the initial design to seamless commercial production. The technology offered by GQ provides numerous advantages, such as exceptional product homogeneity, elevated process quality, enhanced metabolic stability, and low commercialization costs. GQ remains steadfast in its commitment to delivering vital technical support, expediting global ADC drug development. For more information, please visitwww.genequantum.com.