Innovent dosed first participant in Phase 3 clinical study of IBI354 (novel HER2 ADC) for first line treatment of HER2-positive breast cancer

CAR-T Digest - August 2020

Weekly Digest - February 2026

12 February 2026: Innovent dosed first participant in Phase 3 clinical study of IBI354 (novel HER2 ADC) for first line treatment of HER2-positive breast cancer

Innovent Biologics announced that the first patient has been dosed in the pivotal Phase 3 HeriCare-Breast01 trial evaluating its novel HER2 antibody–drug conjugate IBI354 as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer
The randomized, active-controlled study is comparing IBI354, with or without pertuzumab, against the current standard THP regimen (paclitaxel, trastuzumab, and pertuzumab), with progression-free survival as the primary endpoint, positioning IBI354 as a potential next-generation option in the frontline setting
The Phase 3 program builds on encouraging Phase 1/2 data in heavily pretreated HER2-positive breast cancer patients, where IBI354 demonstrated a confirmed objective response rate of 59.1% overall, rising to over 70% at the 9 mg/kg Q3W dose, alongside a median progression-free survival of 14.1 months in that cohort
Importantly, early clinical studies also indicated a favorable safety profile, with low rates of grade 3 or higher treatment-related adverse events and minimal incidence of interstitial lung disease, supporting the company’s strategy of developing a high potency, low-toxicity ADC platform
With two pivotal Phase 3 trials now underway in breast and ovarian cancer, Innovent aims to advance IBI354 as part of its differentiated SoloTx ADC platform, seeking to establish a new first-line treatment standard for patients with HER2-positive advanced breast cancer