Innovent Biologics’ IBI363 shows significant promise for advanced colorectal cancer, with median overall survival of 16.1 months in monotherapy and 15.1% response rate in combination with bevacizumab. The treatment exhibits manageable safety profile and may convert ‘cold tumors’ into ‘hot tumors’, representing a breakthrough in immunotherapy for this challenging cancer type.
In a significant advancement in cancer treatment, the investigational drug IBI363, developed by Innovent Biologics, has shown promising results in treating advanced colorectal cancer. During the recent 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, new data was shared showing that IBI363 monotherapy resulted in a median overall survival (OS) of 16.1 months, compared to 6.4 to 9.3 months seen with standard therapies.
Moreover, when IBI363 is combined with bevacizumab, it demonstrated a confirmed objective response rate (cORR) of 15.1%, which is particularly noteworthy for a disease class typically regarded as difficult to treat. The disease control rate (DCR) for this combination therapy stood at an encouraging 61.6%. The efficacy of IBI363 was more pronounced in patients without liver metastases, achieving a cORR of 31.3% and a median progression-free survival (PFS) of 7.4 months.
Safety remains a vital concern, but so far, data indicates a manageable safety profile. Among participants, 27.9% of those on monotherapy experienced grade 3 or higher treatment-related adverse events, which isn’t uncommon in cancer therapies. The most frequent side effects included arthralgia, anemia, rash, and hypothyroidism, yet notably, no new safety signals were reported.
The Phase 1 studies of IBI363 (NCT05460767 and NCT06717880) included 141 patients, where the vast majority (86.8%) were microsatellite stable, a group that historically benefits less from traditional immunotherapies. The median follow-up was 20.1 months for monotherapy, which is important as it highlights the sustainability of response over time.
Innovent’s development strategy is backed by its strong clinical data, spotlighting the dual mechanism of IBI363 which aims to convert “cold tumors” into “hot tumors”. This could potentially enhance the effectiveness of immunotherapies in colorectal cancer, bridging a notable gap in current treatment options. \n
Prof. Tao Zhang from Tongji Medical College emphasized the need for effective treatments in colorectal cancer given that it’s the third most prevalent cancer globally. “For colorectal cancer that has failed standard treatments, there are limited therapeutic options with short survival periods,” he stated, highlighting the unmet need in this area.
Additionally, Dr. Hui Zhou from Innovent indicated that through established evidence showing IBI363’s robust antitumor activity, there’s optimism for continuous advancements in treating advanced colorectal cancer, especially for patients who traditionally have fewer options.
Overall, IBI363 provides a glimmer of hope as a new treatment strategy and warrants ongoing exploration as further studies unfold.
The ongoing clinical findings regarding IBI363 signpost an encouraging future for colorectal cancer therapy, especially where options are limited. Its ability to significantly extend survival rates and maintain a manageable safety profile may reshape treatment approaches. As more data becomes available, interest will likely grow around the potential of IBI363 combined with established therapies like bevacizumab to improve patient outcomes effectively.
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