Onco-Summaries: Daily Oncology Updates at a Glance

24/07/2025

GenFleet Therapeutics and Verastem Oncology's VS-7375 received the Fast Track Designation from the US FDA for pancreatic cancer (Ref)

The US FDA granted the Fast Track Designation to GenFleet Therapeutics and Verastem Oncology's VS-7375 (oral KRAS G12D (ON/OFF) inhibitor) for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas, and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy.

• Dan Paterson, President and CEO, Verastem Oncology: “The Fast Track Designation for VS-7375 underscores the importance of our potential best-in-class KRAS G12D (ON/OFF) inhibitor. As we continue enrollment in our U.S. Phase 1/2a clinical trial, our goal is to accelerate the program’s development given the lack of FDA-approved, KRAS G12D-targeted treatments for people living with KRAS G12D cancers. Given the encouraging initial safety and efficacy results in China reported by our partner, GenFleet Therapeutics, at ASCO this year, we are excited to be advancing VS-7375 in the U.S. to evaluate it in advanced pancreatic cancer and non-small cell lung cancer and in combination with cetuximab in advanced solid tumors, including colorectal cancer.”

  
  

• The Phase 1/2a VS-7375-101 trial is being conducted in the US, with plans to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors, including PDAC.

BeOne's tislelizumab-based regimen received positive CHMP opinion for resectable NSCLC regardless of PD-L1 (Ref)

The CHMP adopted a positive opinion recommending the approval of BeOne Medicines' tislelizumab (Tevimbra; anti-PD-1) + platinum-containing chemotherapy as a neoadjuvant treatment followed by tislelizumab mono as an adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence. 

• The positive opinion was granted based on results from the the China-specific Ph3 RATIONALE-315/NCT04379635 trial of neoadjuvant tislelizumab + chemo followed by adjuvant tislelizumab (n=226) vs neoadjuvant placebo + chemo followed by adjuvant placebo (n=227) in resectable stage II-IIIA NSCLC pts

  
  

  • MPR: 56.2% vs 15.0% (P<0.0001)

    
    

  • pCR: 40.7% vs 5.7% (P<0.0001)

    
    

  • mEFS: NR vs NR (HR 0.56; P=0.0003)

    
    

  • mOS: NR vs NR (HR 0.62; P=0.0193)