Onco-Summaries: Daily Oncology Updates at a Glance

12/08/2025

Perioperative pembrolizumab + enfortumab vedotin significantly improved EFS, OS and pCR in cisplatin-ineligible MIBC (Ref)

The Phase 3 KEYNOTE-905/EV-303 trial of Merck & Co./MSD's pembrolizumab (Keytruda; anti-PD-1) + Astellas Pharma and Pfizer's enfortumab vedotin (Padcev; anti-Nectin-4 ADC) given before and after radical cystectomy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of EFS, as well as key secondary endpoints of OS and pCR vs radical cystectomy alone in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.

• The trial is continuing to evaluate the secondary endpoints of EFS, OS, and pCR rate for neoadjuvant and adjuvant pembrolizumab vs surgery alone

  
  

• The safety profile of the combo was consistent with the known safety profiles of each agent; no new safety signals were identified

  
  

• The companies plan to share these results with regulatory authorities worldwide and will present the data at an upcoming medical meeting

Bayer and Kumquat signed a $1.3B agreement for Kumquat’s KRAS G12D inhibitor (Ref)

Bayer and Kumquat Biosciences entered into an exclusive global license and collaboration to develop and commercialize Kumquat’s KRAS G12D inhibitor.

• Under the agreement, Kumquat is responsible for the initiation and completion of the Phase 1a study, while Bayer will complete development and commercial activities

  
  

• Kumquat will receive up to $1.3 billion, including upfront, clinical and commercial milestones, and additional tiered royalties on net sales

  
  

• Kumquat retains an exclusive option to negotiate for participating in profit-loss sharing in the US