Onco-Summaries: Daily Oncology Updates at a Glance

29/01/2026

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• Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia

  
  

• Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC

  
  

• The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC

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Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia (Ref)

The US FDA granted the Fast Track designation to Quetzal Therapeutics' QTX-2101 (oral arsenic trioxide capsule) for the treatment of patients with acute promyelocytic leukemia (APL).

• QTX-2101 is currently being evaluated in a global, multicenter, randomized, controlled Phase III clinical trial comparing the investigational oral capsule to standard-of-care therapy in patients with newly diagnosed APL

• The trial builds on pharmacokinetic and safety data from prior Phase I studies conducted in the United States

Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC (Ref)

The US FDA accepted Summit's Biologics License Application (BLA) seeking approval for Summit & Akeso's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy.

• The FDA provided a PDUFA goal action date of November 14, 2026

• The BLA was submitted based on the overall results of the Phase III HARMONi trial

The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC (Ref)

The Phase III IMpower030 trial of neoadjuvant treatment with Roche's atezolizumab (anti-PD-L1) + platinum-based  chemotherapy followed by adjuvant treatment with atezolizumab alone in resectable stage II, IIIA, or select IIIB NSCLC failed to meet the primary endpoint.

• The perioperative regimen failed to meet the primary endpoint of Event Free Survival (EFS) vs neoadjuvant treatment with placebo + platinum-based chemotherapy