AACR 2024/Breakthrough in Treating Recurrent or Metastatic Nasopharyngeal Carcinoma by 
Chinese Medical Team
AACR 2024
We’re thrilled to share groundbreaking updates from the 2024 American Association for Cancer Research (AACR) Annual Meeting!
China’s innovative pharmaceuticals are making waves in early clinical trials, hinting at promising breakthroughs in cancer treatment!
At the forefront is the remarkable research on Treprilimumab, a monoclonal antibody, showcased by Prof. Ma Haiqiang and his team from Sun Yat-sen University Cancer Center.
Their pioneering work focuses on advancing treatments for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), a challenging form of cancer.Treprilimumab, administered subcutaneously, has shown remarkable safety and preliminary efficacy when combined with Gemcitabine and Cisplatin (GP), earning FDA approval in October 2023 for first-line therapy in RM-NPC.
The team initiated the first human clinical trial to assess Treprilimumab’s pharmacokinetics in RM-NPC, aiming to establish optimal subcutaneous dosing regimens for future trials.
The study enrolled RM-NPC patients, confirmed histologically, and previously untreated systemically. Patients received Treprilimumab SC at 240mg Q3W, 360mg Q3W, or 480mg Q6W, in combination with GP for up to 6 cycles, followed by Treprilimumab SC monotherapy until disease progression, intolerable toxicity, or completion of 2 years of treatment. Tumor response was assessed by RECISTv1.1 criteria, with primary endpoints focusing on pharmacokinetics and secondary endpoints including safety, efficacy, and immunogenicity.
From November 24, 2022, to November 20, 2023, 38 patients were enrolled, with a median follow-up of 6.8 months. The median age was 49, with 73.7% male. Pharmacokinetic analysis revealed comparable exposure between Treprilimumab 360mg Q3W SC and 240mg Q3W IV in the first cycle. Overall response rates (ORR) were 100%, 92.3%, and 92.3% for the 240mg, 360mg, and 480mg groups, respectively. By November 20, 2023, 71.1% of patients experienced sustained remission, with no new safety concerns. Grade ≥3 adverse events (AEs) occurred in 76.3% of patients, with no fatalities. Immune-related AEs were reported in 36.8% of patients, with one case of grade ≥3.These groundbreaking findings demonstrate comparable safety and clinical efficacy between Treprilimumab SC and IV formulations when combined with GP in treating RM-NPC patients. The exposure of Treprilimumab 360mg Q3W SC mirrors that of 240mg Q3W IV. Excitingly, Treprilimumab SC formulations are slated for Phase III clinical development, promising hope for enhanced cancer therapies!
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