The first participant in the Phase 3 HeriCare-Breast01 clinical trial of IBI354 in human epidermal growth factor 2 (HER2)-positive breast cancer has been dosed, Innovent Biologics announced in a recent press release.
IBI354 is a HER2-targeted antibody-drug conjugate that binds to HER2 receptors and releases camptothecin, a chemotherapy, into cancer cells. Innovent is studying the drug as a potential first-line therapy for patients with inoperable locally advanced or metastatic HER2-positive breast cancer.
In this multicenter, randomized study, participants will either receive IBI354, with or without pertuzumab, or the standard of care, which includes paclitaxel, trastuzumab and pertuzumab. The primary endpoint of the trial is progression-free survival.
In a previous Phase 1/2 study of patients with advanced solid tumors, the disease control rate with IBI354 was 90.9%. Patients with breast cancer who received 9 milligrams IBI354 per kilogram body weight had an overall response rate of 72.4%. These individuals tried a median of four treatment lines prior to entering the study.
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The most common side effects included nausea, anemia and low white blood cell counts. The incidence of interstitial lung disease, a potential effect of certain cancer treatments, was just 1.2%. All cases were grade 1.
In addition, only 1.2% of treatment-related adverse events resulted in treatment discontinuation, and no deaths occurred.
“IBI354 holds strong potential to offer a new first-line treatment option for patients with HER2-positive advanced breast cancer—one that combines durable antitumor activity with favorable long-term tolerability,” said Zhou Hui, chief research and development officer of oncology at Innovent.
“This ‘high-efficacy, low-toxicity’ therapeutic window may allow a broader range of patients to achieve sustained, high-quality treatment outcomes,” added principal investigator Binghe Xu.
Innovent is also evaluating IBI354 in patients with ovarian cancer in the Phase 3 HeriCare-Ovarian01 study. The company plans to study the drug in other types of cancer as well.
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