Home Medizin Die Antikörperkombination zeigt Sicherheit und Antitumoraktivität bei fortgeschrittenen Krebspatienten

Die Antikörperkombination zeigt Sicherheit und Antitumoraktivität bei fortgeschrittenen Krebspatienten

von NFI Redaktion

In a early clinical study, a combination of antibody-based drugs targeting the immune system showed promising safety data and anti-tumor activity in individuals with various types of advanced cancer. The results are published online in CANCER, a peer-reviewed journal of the American Cancer Society.

Both drugs tested in the study support immune responses against tumor cells. CS1002 enhances the activation and proliferation of T immune cells by binding to a T cell receptor called CTLA-4. CS1003, also known as Nofazinlimab, blocks the programmed cell death protein 1, expressed on various types of immune cells and plays a role in suppressing the immune system.

In this first multicenter, open-label human study conducted from April 26, 2018 to January 18, 2022 at 9 study sites in Australia and China, Phase Ia involved dose escalation monotherapy (Part 1), followed by Phase Ib dose escalation (Part 2) and expansion of combination therapy (Part 3). Various dosing regimens of CS1002 (0.3, 1, or 3 mg/kg every 3 weeks or 3 mg/kg every 9 weeks) were evaluated with 200 mg CS1003 every 3 weeks.

Parts 1, 2, and 3 of the study included 13, 18, and 61 patients with advanced/metastatic solid, recurrent, or refractory tumors. Researchers observed no dose-limiting toxicities or maximum tolerated dose during treatment. Treatment-related side effects such as diarrhea, fatigue, and rash were reported in 30.8%, 83.3%, and 75.0% of patients in Parts 1, 2, and 3, respectively. Serious side effects like colitis and severe skin reactions occurred in 15.4%, 50.0%, and 18.3% of patients, respectively.

Of the 61 patients whose efficacy of treatment could be evaluated, 23 (37.7%) showed a positive response with different types of tumors. Certain types of cancer showed higher response rates with conventional and high-dose CS1002 therapies (1 mg/kg every 3 weeks or 3 mg/kg every 9 weeks) compared to low-dose CS1002 (0.3 mg/kg every 3 weeks), such as melanoma and skin cancer.

CS1002 in combination with CS1003 demonstrated a manageable safety profile across a broad dosing range and showed promising anti-tumor activities across all CS1002 dosing levels,“ wrote the investigators. „This supports further evaluation of CS1002 in combination with CS1003 for the treatment of solid tumors.“


Journal Reference:

Bishnoi, S., et al. (2024) Dual CTLA-4 and PD-1 checkpoint blockade with CS1002 and CS1003 (Nofazinlimab) in patients with advanced solid tumors: A first-in-human dose escalation and expansion study. Cancer. doi.org/10.1002/cncr.35226.

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