China NMPA Approves Padcev Plus Keytruda for Advanced Urothelial Cancer
• China's NMPA has approved Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer (la/mUC).
• The approval is based on the EV-302 trial, which showed the combination significantly improved overall and progression-free survival compared to platinum-based chemotherapy.
• The combination represents the first non-platinum treatment option for Chinese patients with advanced urothelial cancer in the first-line setting.
• This approval marks a significant advancement in the treatment landscape, offering hope for longer survival to Chinese patients with advanced urothelial carcinoma.
Phase 2b Trial of Glecirasib in KRAS G12C-Mutated Non-Small-Cell Lung Cancer
A phase 2b trial investigates the efficacy of Glecirasib in treating KRAS G12C-mutated non-small-cell lung cancer, involving multiple institutions across China and the USA.
JSKN003 Shows Promise in HER2-Positive Solid Tumors and Platinum-Resistant Ovarian Cancer
• JSKN003 demonstrated a 56.8% objective response rate in heavily pretreated patients with platinum-resistant ovarian cancer, irrespective of HER2 expression.
• In HER2-positive solid tumors, JSKN003 achieved a 75% objective response rate and an 89.3% disease control rate, showcasing encouraging antitumor activity.
• The bispecific antibody-drug conjugate exhibited a favorable safety profile in both studies, with manageable adverse events and no treatment-related deaths reported.
• These findings support further clinical investigation of JSKN003 as a potential treatment option for advanced HER2-expressing cancers and platinum-resistant ovarian cancer.
JSKN003 Demonstrates Promising Efficacy in HER2-Positive Cancers and Platinum-Resistant Ovarian Cancer
• JSKN003, an anti-HER2 bispecific antibody-drug conjugate, shows a 56.8% objective response rate in heavily pretreated platinum-resistant ovarian cancer patients.
• In HER2-positive solid tumors, JSKN003 achieves a 75% objective response rate and an 89.3% disease control rate, indicating strong antitumor activity.
• The bispecific ADC exhibits a favorable safety profile with manageable adverse events, supporting further clinical evaluation in various cancer types.
• These findings, presented at ESMO Congress 2024, highlight JSKN003's potential as a novel treatment option for advanced, heavily pretreated cancers.
© Copyright 2025. All Rights Reserved by MedPath