Onco-Summaries: Daily Oncology Updates at a Glance

08/10/2025

Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC (Ref)

The US FDA approved Regeneron Pharmaceuticals' Libtayo® (cemiplimab; PD-1 inhibitor) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

• The approval is based on results from the pivotal Phase 3 C-POST trial of adjuvant Libtayo vs placebo in patients with CSCC at high risk of recurrence after surgery and radiation

  
  

• Libtayo significantly reduced the risk of disease recurrence or death by 68% vs placebo (HR 0.32; 95% CI: 0.20-0.51; p<0.0001)

  
  

• A filing is also under review in the EU, with a decision expected by H1'26

  
  

Werewolf Therapeutics' WTX-124 received the FDA Fast Track Designation for the treatment of cutaneous melanoma (Ref)

The US FDA granted the fast track designation to Werewolf Therapeutics' WTX-124 (conditionally activated IL-2 INDUKINE therapy) for the potential treatment of patients with locally advanced or metastatic cutaneous melanoma after standard of care immunotherapy. 

• WTX-124 is being evaluated in the Phase 1/1b NCT05479812 open-label, multicenter trial as a single-agent and in combination with pembrolizumab for the treatment of multiple advanced solid tumors

  
  

• Daniel J. Hicklin, President and CEO, Werewolf: “At Werewolf we are focusing on efforts to address the high unmet need of cancer patients, and we believe there is significant opportunity with WTX-124 for the potential treatment of advanced cancers. We are encouraged by this Fast Track Designation as an important milestone for the WTX-124 program and because it underscores the urgent need for patients with relapsed/refractory melanoma where treatment options are limited. In the fourth quarter, we anticipate sharing preliminary data from the ongoing WTX-124 Phase 1/1b clinical trial, including in patients with cutaneous melanoma, and engaging with the FDA regarding the potential registration strategy for this agent.”

Vivace Therapeutics' VT3989 received the FDA Fast Track Designation for the treatment of mesothelioma (Ref)

The US FDA granted the fast track designation to Vivace Therapeutics' VT3989 (TEAD autopalmitoylation inhibitor) as a treatment for patients with unresectable malignant nonpleural or pleural mesothelioma whose disease has progressed on prior immune checkpoint inhibitor therapy and platinum-based chemotherapy.

• The Phase 1 NCT04665206 multi-center, open label trial of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural and non-pleural malignant mesothelioma is ongoing

  
  

• Sofie Qiao, President and CEO, Vivace Therapeutics: "We are pleased to receive Fast Track Designation from the FDA for VT3989 in this patient population, which is in desperate need of new and effective therapeutic options. This designation represents another important step in our ongoing development of VT3989 and will offer key advantages as we continue on our path toward potential commercialization of this first-in-class and best-in-class therapy."