1210P The preliminary efficacy and safety of KN026 combined with KN046 treatment in HER2-positive locally advanced unresectable or metastatic gastric/gastroesophageal junction cancer without prior systemic treatment in a phase II study

Disitamab vedotin (RC48) plus toripalimab for HER2-expressing advanced gastric or gastroesophageal junction and other solid tumours: a multicentre, open label, dose escalation and expansion phase 1 trial

“…On the other hand, the synergistic efficacy observed in our present study is consistent with several studies reported previously involving other anti-HER2 therapies and PD-1 inhibitors. 7 , 18 , 19 Mechanically, HER2-positive G/GEJ cancer is a distinct tumour subtype that is characterized by a relatively active immune microenvironment compared with HER2-negative G/GEJ cancers. 5 , 6 We speculate that the benefit from ADCs in combination with immunotherapy is considered to be dependent on preexisting immunity.…”

Gastric cancer treatment: recent progress and future perspectives

“…The ongoing phase II/III trial (KN026-001) is planned to evaluate the survival benefit of KN026 plus chemotherapy in patients with HER2-positive unresectable or advanced G/GEJ adenocarcinoma upon progression after trastuzumab-containing treatment (NCT05427383). Most recently, the preliminary data presented at ESMO 2022 illustrated that KN026 plus KN046, a recombinant humanized PD-L1/CTLA-4 bispecific antibody, had remarkable efficacy and tolerable safety in HER2-positive G/GEJ patients without prior systemic treatment [ 128 ]. In this phase II study, the ORR was 77.8%, and the DCR was 92.6%, indicating the need for a future randomized clinical trial to confirm the efficacy of KN026 plus KN046 treatment versus standard of care.…”

Treatment strategies for patients with HER2-positive gastric cancer

“…An ORR of 53% and DCR of 73% were reported in the chemotherapy-free arm. In addition, another phase II trial, KN026-203, has evaluated the safety and efficacy of combined treatment with the bispecific antibodies KN026 and KN046, and indicated a 77.8% ORR and 92.6% DCR in a GC cohort in the preliminary analysis 20 . Together, these results have shed light on chemotherapy-free treatment of HER2-positive GC.…”