ASTELLAS PHARMA INC.
'In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,' said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. 'Enfortumab vedotin has become a second- and third-line treatment option for many patients around the world with previously treated locally advanced or metastatic urothelial cancer, and an approval in
The BLA submission for enfortumab vedotin is based on data from the EV-203 study (NCT04995419), a single-arm, open-label, multicenter Phase 2 study of enfortumab vedotin in Chinese patients with la/mUC who previously received a PD-1/L1 inhibitor and platinum-based chemotherapy. Results showed that EV-203 met its primary endpoint, showing statistical significance in objective response rate (ORR) by independent review committee (IRC) for patients treated with enfortumab vedotin alone compared to historical controls. Efficacy and pharmacokinetic data from the study are in line with global data, and EV-203 is a bridging study to EV-301, a Phase 3 randomized study that has supported global registrations of enfortumab vedotin, and EV-201 Cohort 1.
Enfortumab vedotin alone and in combination with other therapies is the subject of a robust clinical development program aimed at addressing unmet medical needs across the continuum of urothelial cancer and in other solid tumors.
About Bladder and Urothelial Cancer
Globally, approximately 573,000 new cases of bladder cancer and 212,000 deaths are reported annually.1 Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.2 Approximately 12% of cases are locally advanced or metastatic urothelial cancer at diagnosis.3
In
About the EV-203 Trial
The EV-203 trial (NCT04995419) is a Phase 2, multicenter, single-arm bridging study in
About the EV-301 Trial
The EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized Phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in 608 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapies. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters.
About the EV-201 Trial
The EV-201 trial (NCT03219333) is a single-arm, multi-cohort, multicenter, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1 or PD-L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (Cohort 1) and those who have not received a platinum-containing chemotherapy in this setting and who are ineligible for cisplatin (Cohort 2). The trial enrolled 125 patients in Cohort 1 and 89 patients in Cohort 2 at multiple centers internationally. The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability.
Results of EV-301 and EV-201 Cohort 2 clinical trials supported the full and supplemental approval of PADCEV (enfortumab vedotin-ejfv) by the
About PADCEV
PADCEV (enfortumab vedotin-ejfv) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.5 Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4-expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).6
About Astellas
About
About the Astellas and Seagen Collaboration
Astellas and
Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development), which is included in this press release, is not intended to constitute an advertisement or medical advice.
Seagen Forward-Looking Statements
Certain statements made in this press release are forward-looking, such as those, among others, relating to the potential for NMPA approval in the referenced indication; the timing of any potential approval; the therapeutic potential of enfortumab vedotin alone or in combination; its possible efficacy, safety and therapeutic uses; clinical development programs and planned and ongoing clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, the possibility that the referenced application may not be approved in a timely manner or at all or with the requested label; the risk of adverse events and the potential for newly-emerging safety signals; the risk of adverse regulatory actions and the risk of delays, setbacks or failures in clinical development and regulatory activities, the submission of regulatory applications and the regulatory review process for a variety of reasons, including without limitation the inherent difficulty and uncertainty of pharmaceutical product development, possible required modifications to clinical trials, the inability to provide information and institute safety mitigation measures as may be required by regulatory authorities from time to time, failure to properly conduct or manage clinical trials, and failure of clinical results to support continued development or regulatory approvals. More information about the risks and uncertainties faced by
Contact:
Tel: (310) 430-3476
Email: dcaouette@seagen.com
(C) 2023 Electronic News Publishing, source
