Astellas Pharma - ALPMY STOCK NEWS

Astellas and Seagen have completed submissions for two supplemental Biologics License Applications (sBLAs) to the FDA for PADCEV (enfortumab vedotin-ejfv). One seeks to convert its accelerated approval to regular approval based on the EV-301 trial data, while the second aims for label expansion to include patients with metastatic urothelial cancer previously treated with a PD-1/L1 inhibitor. The FDA is reviewing these applications under the Real-Time Oncology Review pilot program, which aims for expedited access to effective treatments.

Astellas Pharma and Seagen announced positive primary results from the phase 3 EV-301 trial for PADCEV in adult patients with advanced urothelial cancer. The trial showed that patients receiving PADCEV had a median overall survival of 12.9 months, 3.9 months longer than those on chemotherapy (9.0 months). Secondary endpoints also favored PADCEV, with a median progression-free survival of 5.6 months. The findings highlight PADCEV as the first therapy to significantly reduce the risk of death compared to chemotherapy in this patient demographic. Results will be submitted to the FDA and global health authorities.

Astellas Pharma and Seagen announced results from the pivotal phase 2 EV-201 trial, where 52% of patients treated with PADCEV (enfortumab vedotin-ejfv) exhibited an objective response. Among these, 20% achieved a complete response, and the median duration of response was 10.9 months. This trial focused on patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin chemotherapy. The findings, presented at the ASCO GU symposium, will be submitted to the FDA by the end of March as part of a supplemental biologics licensing application.

Astellas Pharma has received conditional approval from China's NMPA for XOSPATA (gilteritinib) to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations. This expedited approval follows priority review status granted in July 2020. Gilteritinib addresses a critical need, as approximately 30% of AML patients have FLT3-ITD mutations, linked to poor prognosis. The approval is based on the Phase 3 ADMIRAL trial, showing gilteritinib increased median overall survival to 9.3 months compared to 5.6 months with traditional chemotherapy.

Astellas Pharma announced the presentation of 42 roxadustat abstracts at the ASN Kidney Week 2020, in collaboration with FibroGen and AstraZeneca. Key findings include the Phase 3 DOLOMITES study and a Japanese Phase 3 study comparing roxadustat and darbepoetin alfa for treating anemia in CKD patients not on dialysis. Roxadustat is under regulatory review in Japan, the U.S., and EU for CKD-related anemia treatments. The data presented aims to demonstrate the efficacy and safety of roxadustat in diverse patient populations.

Astellas Pharma and Seagen announced promising topline results from the second cohort of their pivotal phase 2 clinical trial (EV-201) for PADCEV (enfortumab vedotin-ejfv), aimed at treating advanced urothelial cancer. The study reported a 52% objective response rate and a median duration of response of 10.9 months among patients previously treated with a PD-1/L1 inhibitor and ineligible for cisplatin. The trial's findings will be submitted for discussion with regulatory authorities and presentation at scientific congresses, indicating potential for extended approval of PADCEV in the U.S.

Astellas Venture Management and Mission Bay Capital BioLabs have launched their second Golden Ticket Competition, aimed at supporting entrepreneurial scientists and biotechnology startups. The competition is open for submissions until October 27, 2020, offering winners a year of access to state-of-the-art lab facilities and Astellas' R&D resources. This initiative builds on the success of the inaugural event in 2019, which aided companies like AmbAgon Therapeutics. Astellas is focused on innovations addressing unmet medical needs through collaboration with emerging biotech.

Astellas Pharma has released findings from two studies and a sleep survey that highlight the prevalence of vasomotor symptoms (VMS) during menopause and their disruptive effects on sleep. Approximately 34% of postmenopausal women in the U.S. experience moderate-to-severe VMS, with 61% reporting sleep disturbances. The studies underscore the need for new treatment options for VMS, given their negative impact on women's quality of life. These findings will be presented at the North American Menopause Society's 2020 Virtual Annual Meeting.

Astellas Pharma and Seattle Genetics announced that their phase 3 trial of PADCEV (enfortumab vedotin-ejfv) achieved its primary endpoint, demonstrating a significant improvement in overall survival for patients with locally advanced or metastatic urothelial cancer compared to chemotherapy. Specifically, the trial showed a 30% reduction in the risk of death (HR=0.70; p=0.001) and a 39% reduction in the risk of disease progression (HR=0.61; p<0.00001). Results will be submitted to the FDA for confirmatory approval and are intended to support global registrations.