Astellas Pharma - ALPMY STOCK NEWS

Astellas Pharma announced the publication of results from the Phase 3 SPOTLIGHT trial evaluating zolbetuximab in combination with mFOLFOX6 for patients with CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma. Published in The Lancet, the trial met its primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS). Key findings include a 24.9% reduced risk of progression or death and a median PFS of 10.61 months for zolbetuximab versus 8.67 months for placebo. OS data revealed a 25% reduced risk of death, with median OS of 18.23 months for the treatment group. The SPOTLIGHT study establishes the clinical benefit of zolbetuximab, supporting Astellas' development efforts in gastric cancer.

On April 11, 2023, Kyoto University's Center for iPS Cell Research and Application (CiRA) and Astellas Pharma entered the second phase of their joint research agreement. This phase focuses on enhancing the use of differentiated cells from human induced pluripotent stem cells (iPS cells) for innovative medical solutions. Building on prior research from July 2017 to March 2023, the collaboration will establish a technological platform to produce high-quality iPS cell-derived cells. The key initiatives include developing evaluation systems to improve clinical predictability and creating new cell therapy programs. CiRA's Director, Jun Takahashi, and Astellas' CSO, Yoshitsugu Shitaka, express optimism about the potential advancements in drug discovery and treatment options for various diseases.

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.