ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma Inc. (TSE: 4503) announced that the European Commission has approved PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of adult patients with unresectable or metastatic urothelial cancer. This approval is based on the Phase 3 EV-302 trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-containing chemotherapy. The combination nearly doubled median overall survival to 31.5 months versus 16.1 months with chemotherapy, representing a 53% reduction in death risk. It also extended median progression-free survival to 12.5 months compared to 6.3 months with chemotherapy. This approval aligns with updated clinical guidelines from European medical associations and follows similar approvals in the U.S.

Astellas Pharma has initiated the HIGHLIGHT 1™ Phase 3 clinical study for fezolinetant, an investigational oral, nonhormonal compound aimed at treating moderate to severe vasomotor symptoms (VMS) in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy. VMS, including hot flashes and night sweats, affect up to 97% of breast cancer patients and are a major side effect of adjuvant endocrine therapies. The study is significant as there are currently no approved treatments for moderate to severe VMS in this patient population. Breast cancer is the most common cancer in women globally, with about 2.3 million new cases in 2022, and approximately 77% of breast cancers can be treated with adjuvant endocrine therapies.

Astellas Pharma Inc. announced that China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) for treating adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have previously received platinum-based chemotherapy and PD-1/L1 inhibitors. The approval is based on the global EV-301 and China EV-203 trials, which showed significant improvements in overall survival and objective response rate, respectively.

This approval provides a new treatment option for la/mUC patients in China, where over 92,000 people were diagnosed with bladder cancer in 2022. The EV-203 trial met its primary endpoint, demonstrating a statistically significant objective response rate of 37.5% in Chinese patients. The efficacy and safety data from this trial are consistent with global findings.

Astellas Pharma has received a positive CHMP opinion for zolbetuximab, a first-in-class CLDN18.2-targeted monoclonal antibody, in combination with chemotherapy for the treatment of advanced gastric and gastroesophageal junction cancer. If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy available in the EU. The recommendation is for adult patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2 positive.

The positive opinion is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials. A decision on EU marketing authorization is expected by October 2024. Gastric cancer is the sixth most common cause of cancer-related mortality in Europe, with over 135,000 new cases diagnosed in 2022.

Astellas Pharma Inc. (TSE: 4503) has received a positive opinion from the CHMP recommending approval of PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for first-line treatment of advanced bladder cancer. This recommendation is based on the Phase 3 EV-302 clinical trial results, which showed the combination nearly doubled median overall survival compared to platinum-containing chemotherapy. The trial demonstrated a median OS of 31.5 months for the combination versus 16.1 months for chemotherapy, representing a 53% reduction in risk of death. If approved, this combination will be the first alternative to platinum-containing chemotherapy for unresectable or metastatic urothelial cancer. The European Commission will now review the positive opinion for potential approval in the EU and associated countries.

Astellas Pharma Inc. (TSE: 4503) and Osaka University have announced a research collaboration to develop an innovative pluripotent stem cell-derived cartilage organoid cell therapy for treating intervertebral disc degenerative disease. The partnership combines:

• Osaka University's cartilage tissue creation protocol
• Universal Cells' Universal Donor Cell (UDC) technology
• Astellas Institute for Regenerative Medicine's R&D expertise in cell therapy

This collaboration aims to create a cell therapy with reduced risk of immune rejection by genetically modifying Human Leukocyte Antigen (HLA) using gene editing technology. The partnership represents a significant step in open innovation using UDC technology to develop regenerative therapies for intervertebral disc degenerative disease.

Astellas Pharma announced that the FDA has acknowledged the resubmission of their Biologics License Application (BLA) for zolbetuximab, a CLDN18.2-targeted monoclonal antibody.

If approved, it will be the first therapy for patients with advanced gastric and gastroesophageal junction cancers in the U.S. The FDA has set a target action date of November 9, 2024. A previous FDA review in January 2024 highlighted third-party manufacturing issues, not clinical concerns.

The BLA is based on Phase 3 trials (SPOTLIGHT and GLOW), which showed that 38% of patients had CLDN18.2 positive tumors. Zolbetuximab was recently approved in Japan for similar indications. Financial expectations related to this acknowledgment have already been factored into Astellas' forecasts for the fiscal year ending March 31, 2025.

Astellas Pharma has signed a non-binding memorandum of understanding with YASKAWA Electric to explore creating an advanced cell therapy ecosystem by integrating pharmaceutical and robotics technologies. The collaboration aims to digitize cell manufacturing processes using YASKAWA's humanoid robot, Maholo. This technology could streamline research to commercialization, potentially offering a platform for startups and academia. Astellas will provide cell manufacturing technology and regulatory insights, while YASKAWA will contribute cutting-edge robotics. The financial impact on Astellas for the fiscal year ending March 31, 2025, is expected to be minor.

Astellas Pharma Inc. will present new research at the 2024 ASCO Annual Meeting showcasing scientific advancements in its oncology portfolio. The company will share data from pivotal trials across various hard-to-treat cancers like prostate, urothelial, and gastric/gastroesophageal junction cancers. Key highlights include Phase 3 trial data supporting enfortumab vedotin, final overall survival results from the SPOTLIGHT study on zolbetuximab, and post-hoc analyses of the EMBARK trial on enzalutamide. Astellas continues to focus on innovative therapies for cancer patients.