At the 2024 American Association for Cancer Research (#AACR) Annual Meeting, innovative drugs from China showed promising safety and preliminary efficacy in early clinical trials, attracting high interest from attending experts and researchers, showcasing the strength of #Chineseresearch teams in new drug development.

#TQB2916

A groundbreaking focus of cancer research is on #TQB2916, the latest #CD40 agonist antibody causing a stir in the medical field.

#CD40

 receptors, a member of the tumor necrosis factor receptor family, play a vital role in immune responses. TQB2916, a humanized IgG2 CD40 monoclonal antibody, has demonstrated CD40 activation and promising anti-tumor activity in preclinical studies. With its potential to revolutionize cancer treatment, TQB2916 is currently undergoing its first human study for late-stage solid tumors and lymphomas, led by the team at Tianjin Medical University Cancer Institute & Hospital.

#ECOG

Now, let’s delve into the details: Eligible patients, including those with an ECOG performance status of 0 or 1, adequate hematologic and organ function, and no response to standard treatments, are enrolled. TQB2916 is administered intravenously every 3 weeks until disease progression or unacceptable toxicity. The study utilizes a Bayesian Optimal Interval (BOIN) design to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TQB2916.

From April 2022 to November 2023, a total of 18 patients with solid tumors and 2 with lymphomas underwent TQB2916 monotherapy and were assigned to 7 dose cohorts. Adverse events were observed, with the most common including lipase increase, amylase increase, lymphocyte count decrease, ALT increase, ALP elevation, AST elevation, hypoalbuminemia, and anorexia. However, most adverse events were manageable, primarily Grade 1 or 2 severity.

#Lymphomas

Of the 16 evaluated patients, 3 achieved stable disease according to immune RECIST criteria for solid tumors and LYRIC criteria for lymphomas. Pharmacokinetic analyses showed favorable performance, with no drug accumulation upon repeat dosing. Additionally, dose-dependent occupancy of CD40 receptors was detected, alongside peripheral B cell reduction and increased cytokine secretion.

#Conclusion

TQB2916 achieves CD40 engagement and immune activation through cytokine modulation. With its promising safety and efficacy profile, 200mg has been identified as the preliminary expansion dose. Studies exploring TQB2916 in combination with immune checkpoint inhibitors and/or other anti-cancer therapies are currently underway.

Stay tuned for more updates on this groundbreaking treatment!

You can send electronic copies or photos of genetic testing reports and diagnostic reports to the email address:

doctor.huang@globecancer.com

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The Medical Department will contact you as soon as they receive the reports.