Astellas Announces Positive Results from Enfortumab Vedotin China Bridging Study EV-203 at ASCO 2023

AstellasAstellas Pharma Group will2023Annual Meeting of the American Society of Clinical Oncology (ASCO) during the annual meeting, sharing including marketed products and investigational treatment options15A new research achievement, covering three approved drugs and one treatment solution under development. Among them,Enfortumab VedotinActs directly onNectin-4"First-in-class" antibody-Drug Conjugates (ADC）。EV-203Research as GlobalEV-301The bridging trial of the clinical trial, its research data showsEVMonotherapy in patients previously treated with platinum-based chemotherapy andPD 1/PD-L1The efficacy and safety of inhibitor therapy for locally advanced or metastatic urothelial carcinoma are consistent with global data.

BeijingJune 2, 2023PR Newswire -- Astellas (China) Investment Co., Ltd. today announced that the Phase II study (EV-203 study) evaluating the efficacy, safety, and pharmacokinetic profile of Enfortumab Vedotin in Chinese patients with locally advanced or metastatic urothelial cancer who have previously received platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy has met its primary endpoint. The objective response rate (ORR) for patients receiving EV monotherapy was 37.5% (95% Confidence Interval [CI]: 22.7-54.2), with a disease control rate (DCR) of 72.5%. The efficacy and PK data were consistent with global data.

As a bridging trial for the global EV-301 clinical study, this research aims to evaluate the objective response rate (ORR) of patients receiving EV treatment based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 edition established by the Independent Review Committee (IRC), while also assessing its pharmacokinetic characteristics. The study data were published in abstract form during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

In terms of secondary endpoints, EV also demonstrated clinically meaningful improvements in efficacy. The objective response rate (ORR) assessed by investigators was 42.5%, and the disease control rate (DCR) reached 82.5%. The median progression-free survival (PFS) assessed by the independent review committee was 4.67 months. The median duration of response (DOR) and overall survival (OS) have not yet been reached. Treatment-related adverse events (TRAEs) with EV were mostly grade 1-2, and two patients discontinued treatment due to TRAEs. The safety profile of EV in the treatment population was consistent with previous pivotal studies, with no new safety signals identified.

"The EV-203 study is the first clinical research in China using an ADC targeting Nectin-4 for urothelial cancer. Although only 40 patients were enrolled, this study confirmed that the efficacy of EV monotherapy in Chinese patients with advanced urothelial cancer is consistent with global results without the need for biomarker screening. EV monotherapy is an excellent option for urothelial cancer patients who have failed chemotherapy and immunotherapy. We look forward to the early market entry of EV to benefit more Chinese patients. The EV-302 study is a Phase III clinical trial conducted globally and is currently enrolling participants in China. We expect this clinical study to demonstrate that the combination of EV and PD-1 inhibitors can surpass first-line chemotherapy and become a first-line treatment option for advanced urothelial cancer," noted Professor Guo Jun, the principal investigator of the EV-203 trial and Director of the Department of Melanoma and Genitourinary Tumor Medical Oncology at Peking University Cancer Hospital.

"The current treatment strategies for advanced urothelial carcinoma still focus on platinum-based chemotherapy and immunotherapy, with a significant unmet need for treatment. The emergence of antibody-drug conjugates (ADCs) provides a new treatment option for patients with advanced urothelial carcinoma," said Ms. Wang Na, Deputy General Manager of Astellas China and Director of the Development Department. "Based on the positive results of this study, the marketing application of Enfortumab Vedotin in China was officially accepted by the Center for Drug Evaluation of the National Medical Products Administration in March 2023. We will continue to maintain close communication with Chinese drug regulatory authorities to ensure that Chinese patients can benefit from this innovative treatment as soon as possible."

ContinuousFollowing the positive results of the EV China bridging trial, Astellas will share a total of 15 new research findings at the 2023 ASCO Annual Meeting, including marketed products and investigational treatment options. These research reports cover three approved drugs and one investigational treatment option. With its growing oncology portfolio and new product pipeline, Astellas is committed to researching and identifying targeted therapies in areas where treatment options are extremely limited and cancers are difficult to treat. Key focus areas include prostate cancer, urothelial cancer, gastric cancer/gastroesophageal junction (GEJ) adenocarcinoma, head and neck cancer, and acute myeloid leukemia (AML). For more information, please refer to Astellas' robust oncology portfolio and new product pipeline presented at the 2023 ASCO Annual Meeting (reference link: https://www.astellas.com.cn/zh-hans/news/13951).