ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Seagen Inc. (NASDAQ: SGEN) and Astellas Pharma Inc. (Tokyo: 4503) announced that the FDA has granted accelerated approval for the combination of PADCEV (enfortumab vedotin-ejfv) and KEYTRUDA (pembrolizumab) as a treatment for adult patients with locally advanced or metastatic urothelial cancer who cannot receive cisplatin-containing chemotherapy. This approval is based on tumor response rates from the EV-103 clinical trial, where 68% of patients showed confirmed responses. Continued approval depends on clinical benefit verification in the ongoing EV-302 trial.

Astellas Pharma and Seagen announced FDA accelerated approval for PADCEV (enfortumab vedotin-ejfv) in combination with KEYTRUDA (pembrolizumab) for adults with locally advanced or metastatic urothelial cancer who cannot receive cisplatin-based chemotherapy. This marks the first treatment option combining an antibody-drug conjugate and a PD-1 inhibitor for this patient group, estimated to include 8,000 to 9,000 individuals in the U.S. Approval is based on tumor response rates from the EV-103 trial, and further confirmation of clinical benefit is required from the ongoing EV-302 trial.

Astellas Pharma has announced a partnership with Roche Diabetes Care Japan to develop the Accu-Chek® Guide Me glucose meter integrated with the BlueStar® digital health solution in Japan. The initiative aims to enhance diabetes management for approximately 10 million individuals in Japan, who are diagnosed with diabetes and prediabetes. Clinical trials for this combined medical product are expected to initiate in fiscal year 2023. The collaboration seeks to utilize advanced AI algorithms for personalized coaching and insights, ultimately improving patient self-management and outcomes in diabetes care.

Astellas Pharma announced positive results from the Phase 3 GLOW trial of zolbetuximab plus CAPOX for treating locally advanced, unresectable or metastatic gastric cancer. The study demonstrated a 31.3% reduction in the risk of progression or death compared to CAPOX alone, with a median progression-free survival of 8.21 months. Additionally, overall survival improved by 22.9%, achieving a median of 14.39 months. Serious treatment-emergent adverse events were similar in both treatment and placebo groups. The results will be presented at the upcoming ASCO Plenary Series, paving the way for global regulatory submissions based on the GLOW and SPOTLIGHT trials.

Pfizer (NYSE: PFE) and Astellas Pharma have announced positive topline results from the Phase 3 EMBARK trial, evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) experiencing high-risk biochemical recurrence. The trial met its primary endpoint, demonstrating a significant improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide over placebo. Additionally, significant improvements were noted for patients on XTANDI monotherapy. A positive trend in overall survival was also observed and further data analysis is ongoing. Detailed results will be presented at a future medical meeting.

Pfizer and Astellas announced positive topline results from the Phase 3 EMBARK trial for XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) at high risk for biochemical recurrence. The trial met its primary endpoint, showing a statistically significant improvement in metastasis-free survival when comparing XTANDI plus leuprolide to placebo plus leuprolide. Additionally, XTANDI monotherapy also demonstrated significant benefits. Preliminary safety analyses revealed no new safety signals. Further details will be presented at future medical meetings, and discussions with the FDA for regulatory submission are anticipated.

Astellas Pharma announced the publication of pivotal Phase 3 SKYLIGHT 1 study results for fezolinetant, a nonhormonal treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, in The Lancet. The study demonstrated statistically significant reductions in VMS frequency and severity at 4 and 12 weeks, with improvements lasting through the 52-week trial. Treatment-emergent adverse events occurred in 37-45% of participants, with common events being headache and COVID-19. Regulatory applications for fezolinetant are under review in multiple regions, and if approved, it could become the first nonhormonal option for treating menopausal VMS.

Astellas Pharma announced positive results from the Phase 3 China ARCHES study of XTANDI^® (enzalutamide) combined with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study, involving 180 patients, achieved its primary endpoint by significantly delaying prostate-specific antigen (PSA) progression compared to placebo plus ADT. Key secondary endpoints were also met, indicating reduced radiographic progression-free survival (rPFS) and higher rates of undetectable PSA. These findings support XTANDI’s potential as a treatment option, pending regulatory approval from the China National Medical Products Administration (NMPA).

Astellas Pharma and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) announced that the Phase 3 MORPHO trial of gilteritinib did not meet its primary endpoint of relapse-free survival (RFS) in patients with FLT3-ITD mutated acute myeloid leukemia (AML) after allogeneic stem cell transplantation. The study involved 356 patients and was double-blind and placebo-controlled. Despite not achieving significant RFS, Astellas remains committed to advancing treatment options for AML. The results will be analyzed further for additional secondary endpoints. This outcome is not expected to impact the financial forecasts for the fiscal year ending March 31, 2023.