Onco-Summaries: Daily Oncology Updates at a Glance

28/10/2025

Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC (Ref)

The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC).

• To note, in Sep'24, Alphamab  entered a licensing agreement with JMT-Bio Technology (a wholly-owned subsidiary of CSPC Pharmaceutical Group) under which JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan). Alphamab retains exclusive production rights for JSKN003.

Phase 3 LITESPARK-011 trial of belzutifan + lenvatinib met its PFS endpoint in previously treated RCC (Ref)

Merck & Co./MSD and Eisai reported that the Phase 3 LITESPARK-011 trial of belzutifan (HIF-2α inhibitor) + lenvatinib (multiple receptor tyrosine kinase inhibitor) met one of its primary endpoints of PFS for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-PD-1/L1 therapy.

• At a pre-specified interim analysis, the combo elicited a statistically significant and clinically meaningful improvement in PFS vs cabozantinib

  
  

• The combo also showed a statistically significant improvement in the trial’s key secondary endpoint of ORR

  
  

• A trend toward improvement in OS (the other primary endpoint) was observed. However, this result did not reach statistical significance at the time of this interim analysis. OS will be tested at a subsequent analysis, per the clinical protocol.

Exousia Pro's exosome-based therapy received the FDA orphan drug designation for GBM (Ref)

The US FDA granted the orphan drug designation to Exousia Pro's exosome-based therapy for Glioblastoma multiforme (GBM).

• Marvin S. Hausman, Chairman, Scientific Advisory Board: "GBM is the most common and highly malignant central nervous system (CNS) tumor that currently lacks adequate treatment. Our breakthrough exosomal technology has the ability to deliver a wide range of therapeutics, including genetic material, into cells afflicted with cancer, such as GBM. The therapeutic technology presented in this orphan drug application is a method for using exosomes loaded with desired nucleic acids, in the effective treatment of GBM when combined with currently available standard anticancer therapy."