Innovent Presents IBI354 Clinical Data on Various Cancers at 2024 ESMO Congress

Innovent Biologics, Inc., a premier biopharmaceutical company based in San Francisco and Suzhou, China, shared pivotal clinical data on its HER2 monoclonal antibody-camptothecin derivative conjugate, IBI354, at the 2024 ESMO Congress. The Phase 1/2 study aimed to assess the safety, tolerability, and preliminary efficacy of IBI354 in treating advanced solid tumors.

The study included 368 participants who had advanced solid tumors. Among them were 178 breast cancer patients, 92 ovarian cancer patients, 38 colorectal cancer patients, and 60 patients with other tumors. Notably, 42.7% of the participants had undergone five or more previous systemic treatments. The participants received various doses of IBI354 monotherapy, which showed a favorable safety profile with dose escalation up to 18mg without dose-limiting toxicity (DLT) events.

Common treatment-related adverse events (TRAEs) included nausea, decreased white blood cell count, and anemia. The incidence of interstitial lung disease (ILD) was 1.6%, all of which were grade 1. Overall, 21.5% of the patients experienced grade 3 or higher TRAEs, 2.4% required dose reductions due to TRAEs, and 1.6% discontinued treatment because of TRAEs. Importantly, no TRAEs led to death.

IBI354 showed promising efficacy across multiple tumor types. For the platinum-resistant ovarian cancer cohort (n=87, treated at doses ranging from 6 to 12mg/kg), the overall objective response rate (ORR) was 40.2%, and the disease control rate (DCR) was 81.6%. Within the 12mg/kg subgroup (n=40), the ORR was 52.5%, and the DCR reached 90.0%. Participants with HER2 1+ (n=27) saw an ORR of 55.6% and a DCR of 88.9%. At the data cutoff, the median follow-up was 6.5 months, with both progression-free survival (PFS) and duration of response (DoR) not yet matured.

In the HER2-positive breast cancer cohort (n=59, treated at 6 to 15mg/kg), the ORR was 67.8% and the DCR was 88.1%. The HER2-low breast cancer cohort (n=67, treated at 6 to 15mg/kg) demonstrated an ORR of 41.8% and a DCR of 82.1%. In the 12mg/kg subgroup (n=26), the ORR was 61.5% and the DCR was 88.5%. For HER2-positive gastrointestinal malignancies (n=35, treated at 6 to 15mg/kg), the ORR was 57.1% and the DCR was 91.4%. Among 26 participants with colorectal cancer, 14 achieved an objective response, resulting in an ORR of 53.8% and a DCR of 92.3%.

Professor Qi Zhou from Chongqing University Affiliated Cancer Hospital emphasized the need for new treatment options for platinum-resistant ovarian cancer, noting the promising activity of IBI354 in this patient population. Dr. Daphne Day from Monash Health highlighted the significant role of HER2-targeted therapy in breast cancer and the encouraging preliminary results of IBI354 in HER2-positive and -low breast cancer. Professor Lin Shen from Peking University Cancer Hospital noted the rising incidence of colorectal cancer in China and the positive preliminary efficacy of IBI354 in HER2-positive gastrointestinal malignancies.

Dr. Hui Zhou, Senior Vice President of Innovent, highlighted the company's strategic focus on antibody-drug conjugates (ADCs) and the potential of IBI354 to offer new treatment options for patients with advanced malignancies. Innovent continues to invest in research and development of ADC molecules, reinforcing its commitment to providing innovative treatments for challenging diseases.

IBI354 leverages Innovent's novel topoisomerase inhibitor NT3 platform, featuring a high drug-to-antibody ratio (DAR) of 8, which enhances its anti-tumor activity. The molecule has shown significant promise in preclinical and clinical settings, particularly in tumors resistant to other HER2-targeted therapies.

Innovent Biologics, founded in 2011, aims to make high-quality biopharmaceuticals accessible globally. The company focuses on discovering and developing therapies for cancer, cardiovascular, metabolic, autoimmune, and eye diseases. Innovent has already launched 11 products and continues to advance numerous other candidates through various stages of clinical development.