Urothelial carcinoma (UC) is a common type of bladder cancer, accounting for approximately 90% of all bladder cancers. In recent years, neoadjuvant chemoradiotherapy and immunotherapy have made more and more significant progress in the field of urothelial carcinoma, providing a new direction for the treatment of urothelial carcinoma patients.
Padcev received accelerated approval from the U.S. Food and Drug Administration (FDA) for use in patients with locally advanced or metastatic urothelial carcinoma who have previously been treated with a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy regimen as part of neoadjuvant/adjuvant therapy or locally advanced or metastatic disease.
The approval is based on results from the first cohort of pivotal Phase II ev-201, which showed that Padcev treatment rapidly shrank tumors in the majority of patients, with an objective response rate of 44%(55/125, 95%CI:35.1-53.2) and a complete response rate of 12%(15/125). Median duration of response was 7.6 months (range 0.95 to 11.3+).
Padcev is a newADC that targets a cell surface protein that is highly expressed in bladder cancer. The drug is made by coupling human IgG1 monoclonal antibody enfortumab, which targets connexin-4 (nectin-4), with the cytotoxic agent MMAE(Monomethyl auristatin E, a microtubule destroyer). Nectin-4 is a highly expressed therapeutic target in a variety of solid tumors, including urothelial carcinoma (UC). The Padcev and Keytruda combination regimen has also shown promising results in the treatment of urothelial carcinoma, providing a new direction for urothelial carcinoma patients. Padcev has been approved for marketing in the United States and is in clinical trials in Japan, where approval is expected. For patients with urothelial carcinoma, the approval of Padcev may provide a new treatment direction.
Reference
アステラス製薬、抗体-薬物複合体「PADCEV」が局所進行性または転移性尿路上皮がんへの適応について米国で承認取得:日本経済新聞