Onco-Summaries: Daily Oncology Updates at a Glance

08/08/2025

Boehringer Ingelheim's Hernexeos received accelerated approval from the US FDA for HER2-mutant advanced NSCLC (Ref)

The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (Hernexeos; kinase inhibitor) for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.

• The approval is based on data from the Phase 1b Beamion-LUNG 1 trial in which the regimen elicited an ORR of 75% (N=71), including 6% of patients with CR; DOR of ≥6 months was seen in 58% of patients

  
  

• Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial

Junshi's sNDA for toripalimab + disitamab vedotin accepted by the NMPA for HER2-expressing urothelial carcinoma (Ref)

China's NMPA accepted Shanghai Junshi Biosciences' sNDA for toripalimab (TUOYI; anti-PD-1) + RemeGen's disitamab vedotin (HER2 ADC) as the treatment of HER2-expressing, locally advanced or metastatic urothelial carcinoma.

• The sNDA is based on results from the Phase 3 RC48-C016 trial of toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin in treatment-naive, HER2 expressing, locally advanced or metastatic UC

  
  

• The trial met its primary endpoints of PFS and OS; toripalimab had a good safety profile that was consistent with previous studies, with no new safety signals identified

Arvinas and Pfizer's NDA for vepdegestrant accepted by the US FDA for the treatment of ESR1m, ER+/HER2- advanced Breast Cancer (Ref)

The US FDA accepted the NDA for Arvinas and Pfizer's vepdegestrant (PROteolysis TArgeting Chimera estrogen receptor degrader) for the treatment of patients with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy.

• The FDA has assigned a PDUFA action date of June 05, 2026

  
  

• The NDA was based on data from the Phase 3 VERITAC-2 global, randomized trial evaluating vepdegestrant vs fulvestrant

  
  

• In Jul'21, Arvinas and Pfizer had signed a global collaboration for the co-development and co-commercialization of vepdegestrant