ASTELLAS PHARMA EUROPE LTD.

The European Commission approved zolbetuximab (Vyloy) plus chemotherapy for HER2-negative, Claudin 18.2-positive gastric and gastroesophageal junction cancers. Zolbetuximab, targeting CLDN18.2, showed improved progression-free and overall survival in phase 3 trials SPOTLIGHT and GLOW. Common side effects included vomiting, nausea, and decreased appetite.

Pancreatic cancer, a leading cause of cancer deaths worldwide, affects older adults more frequently and has a poor prognosis. 2024 guidelines recommend tailored FOLFIRINOX and gemcitabine-based therapies. Over 2,000 trials since 2019, led by North America, Asia-Pacific, and Europe, are advancing treatments. Novotech, a global CRO, supports oncology trials, highlighting progress in chemotherapy, RAS-targeted therapies, and personalized medicine.

Power's AI platform simplifies patient access to clinical trials, reducing recruitment delays and enhancing patient understanding, as highlighted at DPHARM Idol Disrupt 2024.

Eli Lilly’s 177Lu-PNT2002, compared to ARPIs like Xtandi and Zytiga, showed efficacy in mCRPC patients positive for PSMA at ESMO 2024. Despite initial negative OS results, crossover adjustments led to a favorable HR of 0.68, likely influencing FDA approval. 177Lu-PNT2002, with lower dosage and fewer cycles than Pluvicto, may challenge Novartis’s market position.

FDA grants RMAT designation to Poseida Therapeutics' P-BCMA-ALLO1, an allogeneic CAR-T therapy for relapsed/refractory multiple myeloma, based on positive Phase 1 study data.

Preoperative chemoradiotherapy did not improve survival over perioperative chemotherapy alone in resectable gastric and gastroesophageal junction adenocarcinoma, according to TOPGEAR data. Median overall survival was 46.4 months vs 49.4 months, with no significant differences in progression-free survival. However, preoperative chemoradiotherapy significantly improved pathological outcomes, including complete response rates and tumor downstaging.

Various researchers report financial relationships with pharmaceutical companies, including Deciphera, during and outside the conduct of the study.

Enfortumab vedotin + pembrolizumab could replace platinum-based chemo for unresectable/metastatic urothelial cancer, per CHMP's positive opinion based on Phase 3 EV-302 trial results showing nearly double median overall survival.

Panel discusses AI's impact on bioeconomy, emphasizing risks and need for critical evaluation. Concerns include workforce unpreparedness, regulatory challenges, and cybersecurity threats. AI's potential in drug discovery is noted, but trust and investment remain uncertain.

A report by the Access to Medicine Foundation examines how 20 major pharmaceutical companies are addressing patient access in low- and middle-income countries (LMICs), highlighting progress and areas needing improvement. The report identifies 42 different approaches to measuring patient reach, with 19 companies actively tracking this, but no industry-wide consensus. It calls for clearer, more actionable commitments to ensure lifesaving products reach underserved populations, emphasizing the need for collaboration and refining measurement methods to address health inequities.