Recently, the world's first dual-antibody ADC drug BL-B01D1 independently developed by Baili Tianheng has made significant progress in the Phase III clinical trial for the treatment of locally advanced or metastatic nasopharyngeal carcinoma. The analysis results show that the drug has successfully reached the primary endpoint and may bring new treatment options for nasopharyngeal carcinoma patients.

Nasopharyngeal carcinoma is a highly invasive and recurrent head and neck malignant tumor. Although immunotherapy and targeted therapy have made some progress in recent years, treatment options are still limited for patients with recurrent or metastatic nasopharyngeal carcinoma, especially those who have failed multiple lines of treatment. Baili Tianheng's BL-B01D1 came into being in this context. With its unique innovative drug mechanism, it brings new ideas to the treatment of nasopharyngeal carcinoma.

BL-B01D1 is an EGFR×HER3 dual-antibody ADC drug. Its design principle is to simultaneously target two key targets, epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), to block the signal transduction pathway of tumor cells, thereby inhibiting tumor growth and metastasis.

This dual-target design not only improves the precision of the drug, but also enhances its anti-tumor activity. In the previous Phase I clinical trial, BL-B01D1 has shown remarkable efficacy: among 37 patients with nasopharyngeal carcinoma who could be evaluated for efficacy, the objective response rate (ORR) reached 59.5%. These data have laid a solid foundation for the success of the Phase III clinical trial.
The smooth progress of this Phase III clinical trial (study protocol number: BL-B01D1-303) further verified the potential of BL-B01D1 in the second-line treatment of NPC. The primary endpoints of the trial were objective response rate (ORR) and overall survival (OS), and the secondary endpoints included duration of response (DoR) and progression-free survival (PFS). The analysis results showed that BL-B01D1 achieved the expected goals in these key indicators, showing significant efficacy and good safety.

It is worth mentioning that the internationalization process of BL-B01D1 is also progressing steadily. In December 2023, Baili Tianheng signed an exclusive licensing and cooperation agreement with Bristol-Myers Squibb (BMS), a global leading pharmaceutical company, with a potential total transaction value of US$8.4 billion. This cooperation not only provides strong support for the global research and development and commercialization of BL-B01D1, but also marks the increasing influence of Chinese innovative drugs in the global market.

Currently, BL-B01D1 is conducting more than 40 clinical trials for various tumor types in China and the United States, and is expected to achieve breakthroughs in more indications in the future.

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