ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma and Seagen have completed patient enrollment in Cohort K of the EV-103 clinical trial, testing PADCEV in combination with KEYTRUDA against metastatic urothelial cancer. This phase 1b/2 trial focuses on patients unable to receive cisplatin-based chemotherapy. The FDA granted Breakthrough Therapy designation for this combination in February 2020. Positive trial results may lead to an accelerated approval application to the FDA. Urothelial cancer comprises a significant portion of bladder cancer cases, with an estimated 83,730 diagnoses in the U.S. in 2021.

Enfortumab vedotin has received approval in Japan for patients with advanced urothelial carcinoma that cannot be surgically removed. The approval by Japan's MHLW follows a priority review and is mainly based on the global Phase 3 EV-301 clinical trial. In the trial, patients treated with enfortumab vedotin showed a median overall survival of 12.9 months, compared to 9.0 months for those receiving chemotherapy, indicating improved outcomes. This ADC targets Nectin-4, a protein commonly found in bladder cancer cells, addressing a significant unmet medical need in the region.

Astellas Pharma and Seagen announced on Sept. 27, 2021 that Japan's Ministry of Health, Labour and Welfare has approved PADCEV (enfortumab vedotin) for treatment of radically unresectable urothelial carcinoma post-chemotherapy. The approval followed a six-month priority review based on the Phase 3 EV-301 trial, which showed a median overall survival of 12.9 months for PADCEV versus 9.0 months for chemotherapy. This treatment addresses a significant need, as over 24,300 bladder cancer cases are diagnosed annually in Japan, with about 9,500 deaths.

Astellas Pharma announced the 12-week results from the pivotal Phase 3 SKYLIGHT 2 clinical trial of fezolinetant, aimed at treating moderate to severe vasomotor symptoms (VMS) associated with menopause. The trial demonstrated that both 30 mg and 45 mg doses achieved significant reductions in VMS frequency and severity compared to placebo. Adverse events were reported in 40% of the treatment group, with headache as the most common. The findings underscore the potential of fezolinetant as a non-hormonal treatment option for VMS, with plans for further development and safety studies.

Astellas Venture Management and MBC BioLabs announced the third iteration of the Future Innovator Prize, aimed at supporting entrepreneurial scientists and biotech startups. The competition offers winners a year of access to MBC BioLabs’ facilities and Astellas’ R&D resources. Interested parties can submit their applications until November 1, 2021. The initiative seeks to accelerate novel therapeutic programs, especially in oncology, immunology, and neuroscience. Previous winners have shown potential in addressing unmet medical needs, reflecting a commitment to innovative science for patient benefit.

Astellas Pharma and Pfizer announced that XTANDI (enzalutamide) improved overall survival in the Phase 3 ARCHES trial for men with metastatic hormone-sensitive prostate cancer (mHSPC). The study involved 1,150 patients and showed a 34% reduction in the risk of death (HR=0.66; p<0.0001) compared to placebo. Median OS was not reached in either group. Results are set to be presented at the ESMO Congress. This marks the third stage where enzalutamide has shown survival benefits in advanced prostate cancer, enhancing its clinical profile in earlier disease settings.

Astellas Pharma has reported a serious adverse event in the ASPIRO clinical trial for AT132, aimed at treating X-linked Myotubular Myopathy. A participant, who had developed this adverse event, tragically passed away on September 9, 2021. This incident has prompted Astellas to pause screening and dosing in the trial, which had resumed after a previous FDA clinical hold. The FDA has placed the ASPIRO trial on hold again, pending further review. Astellas remains committed to investigating the findings and continuing the development of AT132.

Astellas Pharma announced a voluntary pause in the ASPIRO clinical trial for AT132, a gene therapy for X-linked Myotubular Myopathy (XLMTM), following a serious adverse event involving abnormal liver function in a participant. This pause affects screening and dosing of new participants, though no Investigational New Drug clinical hold has been issued yet. Since the trial began, 24 participants have received AT132, with past adverse liver events leading to fatalities. Astellas continues to monitor existing participants and will provide updates on the investigation.

Astellas Pharma and FibroGen announced the European Commission's approval of EVRENZO™ (roxadustat) for treating symptomatic anemia linked to chronic kidney disease (CKD) in adults. This makes roxadustat the first oral HIF-PH inhibitor available in the EU, enhancing treatment options for CKD patients. The approval follows a positive opinion from the EMA and triggers a $120 million milestone payment from Astellas to FibroGen. The comprehensive Phase 3 program involved 9,600 patients and demonstrated efficacy in maintaining target hemoglobin levels.