Onco-Summaries: Daily Oncology Updates at a Glance

10/07/2025

TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC (Ref)

• The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + gemcitabine + cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy

  
  

  • The approval is based on results from the Phase 3 RATIONALE-309 trial which met the primary endpoint of PFS (HR 0.52; p<0.0001)

  • Prof. Lisa Licitra, Chief of the Head and Neck Cancer Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori: “The approval of TEVIMBRA combined with chemotherapy in Europe marks an important advancement for people with recurrent or metastatic nasopharyngeal carcinoma—a rare and challenging disease. Thanks to the compelling results from the RATIONALE-309 study, we now have a powerful new treatment that not only delays disease progression but also helps patients live longer. This approval brings new hope and a clinically proven option to patients who urgently need better care.”

Arcus’ quemliclustat received Orphan Drug Designation for Pancreatic Cancer (Ref)

• The US FDA granted the Orphan Drug Designation to Arcus Biosciences' quemliclustat (CD73 inhibitor) for the treatment of pancreatic cancer

• Richard Markus, CMO, Arcus Biosciences: “The orphan drug designation indicates the importance of developing new treatment options for rare diseases like pancreatic cancer, which has the highest mortality rate of all major cancers, and which has seen few treatment advancements over the past 30 years. We expect the Phase 3 PRISM-1 study to be fully enrolled this year and, if positive, intend to quickly bring this new first-line treatment option to patients, with the goal of prolonging survival for those with metastatic pancreatic cancer.”

  
  

• The Phase 3 PRISM-1 registrational trial of quemliclustat + chemotherapy as a first-line treatment for metastatic pancreatic cancer is expected to be fully enrolled by the end of 2025