Innovent Doses First Participant in Pivotal Phase 3 Clinical Trial for IBI354 Targeting HER2-Positive Breast Cancer

Innovent Begins Phase 3 Trial for IBI354 in HER2-Positive Breast Cancer

Innovent Biologics, Inc., a leading biopharmaceutical company, has successfully dosed the first participant in its pivotal Phase 3 clinical study for IBI354, a novel HER2 antibody-drug conjugate (ADC). This innovative treatment is aimed at patients suffering from unresectable locally advanced or metastatic HER2-positive breast cancer, a condition affecting many women globally.

Clinical Study Overview

The study, referred to as HeriCare-Breast01, is a multicenter, randomized, open-label trial designed to compare the safety and effectiveness of IBI354 with that of the current standard treatment. The current standard, which includes paclitaxel plus trastuzumab and pertuzumab (known as THP), has shown improvements in first-line treatment for HER2-positive advanced breast cancer but still faces challenges related to side effects and tolerability.

As part of the trial, IBI354 will be tested either alone or in combination with pertuzumab. The primary goal is to determine progression-free survival (PFS) among participants, providing crucial evidence regarding the treatment's efficacy.

Previous Findings and Promising Data

Prior studies have laid a strong foundation for IBI354, particularly a multicenter Phase 1/2 trial that included 88 participants with HER2-positive breast cancer. Results demonstrated an impressive overall confirmed objective response rate (cORR) of 59.1%, with a disease control rate (DCR) of 90.9%. For those treated specifically at a dose of 9 mg/kg, the ORR reached 72.4% and the DCR was recorded at 89.7%.

These statistical achievements, presented at the ASCO 2025 conference, underline the potential of IBI354 to outperform existing therapies. Furthermore, remarkable results indicated that the median follow-up time for this treatment was 13.6 months, with an encouraging PFS of 14.1 months.

Credit for this impressive safety profile belongs to the innovative design of IBI354, which reduced risks of treatment-related adverse events. The most common issues faced were manageable and included reduced white blood cell counts and mild nausea without severe grades.

Expert Insights

Binghe Xu, the principal investigator, expressed optimism towards the HeriCare-Breast01 study. He highlighted that even though first-line treatments have improved, toxicity and limited tolerability remain critical challenges, especially for elderly patients and those with multiple health conditions. In contrast, IBI354’s characteristics suggest it could lead to better treatment outcomes with less severe side effects.

Dr. Zhou Hui, Innovent’s Chief RD Officer for Oncology, emphasized the significance of this Phase 3 trial. It is a key step in advancing their ADC pipeline and represents a potential breakthrough in first-line treatment options for HER2-positive breast cancer. Harnessing advanced antibody engineering, Innovent aims to refine IBI354’s therapeutic profile further, potentially offering a solution that is both effective and easier for patients to tolerate.

The Future of Breast Cancer Treatment

Breast cancer remains a major healthcare issue, affecting approximately 1.3 million women annually, with a significant portion transitioning to advanced stages, including HER2-positive types. Given that current ADC treatments have not yet been fully approved for first-line use in advanced cases in China, there is an immediate demand for new therapies that can improve patient prognosis.

In summation, IBI354's promising data and the commencement of the HeriCare-Breast01 trial signify a crucial moment in the quest for innovative treatments for HER2-positive breast cancer, aiming to enhance the quality of life for patients battling this formidable disease.

For further information, visit Innovent's website or reach out through their social media channels.