Onco-Summaries: Daily Oncology Updates at a Glance

24/11/2025

Avenzo Therapeutics' AVZO-103 received the FDA fast track designation for metastatic urothelial cancer (Ref)

The US FDA granted the fast track desingation to Avenzo Therapeutics' AVZO-103 (Nectin4/TROP2 bispecific antibody-drug conjugate) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin.

• Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer, Avenzo Therapeutics: “Receiving Fast Track designation for AVZO-103 highlights the significant need for treatment options for patients with urothelial cancer who have progressed on enfortumab vedotin. We believe AVZO-103 has the potential to become a promising treatment option for patients and we are committed to rapidly advancing its clinical development.”

• AVZO-103 is currently being studied in a Phase 1/2 open-label trial to evaluate the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors

The Phase 3 OptiTROP-Lung05 trial of sacituzumab tirumotecan + pembrolizumab met the primary endpoint of PFS in PD-L1-positive advanced NSCLC (Ref)

In the Phase 3 OptiTROP-Lung05 trial of Merck & Co./MSD's and Sichuan Kelun-Biotech's sacituzumab tirumotecan (sac-TMT; TROP2 ADC) in combination with pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in PFS as a first-line treatment for PD-L1-positive advanced NSCLC.

• A positive trend in overall survival was also observed

  
  

• Based on the results from the interim analysis, the company plans to communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China regarding the submission of a supplemental new drug application (sNDA) of sac-TMT

BMS' Breyanzi received the EC approval for R/R mantle cell lymphoma (Ref)

The European Commission granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; CD19-directed CAR-T cell therapy) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

• The decision is based on results from the MCL cohort of the TRANSCEND NHL 001 trial 

• Emma Charles, Senior vice president, Europe Region, Bristol Myers Squibb: “This approval for Breyanzi in relapsed or refractory mantle cell lymphoma marks another important step as we continue to deliver on the promise of cell therapy for more eligible patients across Europe – the fourth approval for Breyanzi in Europe. While frontline therapies have advanced over the years for this rare but aggressive form of non-Hodgkin lymphoma, the vast majority of patients relapse or become resistant and face reduced survival outlook, leaving a critical need for new treatment options. Breyanzi has the opportunity to address a treatment gap for this patient population based on its demonstrated clinical benefit.”

Phase 3 JS001sc-002-III-NSCLC trial of toripalimab subcutaneous + chemo met its primary endpoints in non-squamous NSCLC (Ref)

The Phase 3 JS001sc-002-III-NSCLC trial of Shanghai Junshi Biosciences' toripalimab subcutaneous injection (anti-PD-1) in combination with chemotherapy met its primary endpoints for the first-line treatment of recurrent or metastatic non-squamous NSCLC.

• Junshi Biosciences plans to submit a NDA to the regulatory authorities in the near future

• Dr. Jianjun ZOU, General Manager and CEO, Junshi Biosciences: “Since its launch as China's first domestically developed PD-1 antibody drug, toripalimab has secured approvals for 12 indications, benefiting a significant number of patients. In clinical practice, we observed that patients undergoing immunotherapy, either as monotherapy or combination maintenance therapy, face challenges such as frequent intravenous catheterization and time-consuming infusions. The recent success of the Phase 3 study for JS001sc, achieved through the efforts of both patients and the research team, marks not only a pivotal breakthrough in transitioning I-O therapy from 'efficacy' to 'convenience', but also exemplifies Junshi Biosciences' patient-centric ambition.“

  
  

  • By innovating drug delivery methods, we enhance treatment accessibility: simplifying procedures for patients, reducing their healthcare burden, and alleviating pressure on medical resources. We are committed to advancing the registration of JS001sc and providing more patients with a better treatment experience alongside clinical benefits.”