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Pivotal Study of Iodine-131–Labeled Chimeric Tumor Necrosis Treatment Radioimmunotherapy in Patients With Advanced Lung Cancer

From the Zhongshan Hospital and Tumor Hospital, Fudan University, Shanghai; Nanjng Chest Hospital Oncology Department, Nanjing; Zhujiang Hospital Oncology Center, First Military Medical University, Guangzhou; Second Hospital, Zhejiang University Medical School, Hangzhou; Department of Oncology, Liaoning Tumor Hospital, Shenyang; 309 Hospital Oncology Department, Beijing; Shanghai MediPharm Biotech Co Ltd, Shanghai, China; and University of Southern California Keck School of Medicine, Los Angeles, CA

Address reprint requests to Dian Wen Ju, MD, Shanghai MediPharm Biotech Co Ltd, Bldg 72-2F, 887 Zu Chong Zhi Road, Zhangjiang HiTech Park, Shanghai 201203, China; e-mail: jud{at}vip.sina.com

PURPOSE: Tumor necrosis treatment (TNT) uses degenerating tumor cells and necrotic regions of tumors as targets for radioimmunotherapy. Previous studies in animal tumor models and clinical trials have demonstrated that when linked to the therapeutic radionuclide iodine-131, recombinant chimeric TNT antibody (¹³¹I-chTNT) can deliver therapeutic doses to tumors regardless of the location or type of malignancy. Therapeutic efficacy and toxicity of ¹³¹I-chTNT in advanced lung cancer patients were studied in this pivotal registration trial.

PATIENTS AND METHODS: Patients with advanced lung cancer were treated with systemic or intratumoral injection of ¹³¹I-chTNT in eight oncology centers in China. The objective response rate (ORR) was assessed as the primary end point.

RESULTS: All 107 patients who were entered onto the study and completed therapy had experienced treatment failure after prior radiotherapy or chemotherapy a mean of three times. The results showed an ORR of 34.6% (complete response, 3.7%; partial response, 30.8%; no change, 55.1%; and progressive disease, 10.3%) in all patients and 33% in 97 non–small-cell lung cancer patients. A biodistribution study demonstrated excellent localization of the radioactivity in tumors in both systemically and intratumorally injected patients. The most obvious adverse side effect was mild and reversible bone marrow suppression.

CONCLUSION: Radioimmunotherapy with ¹³¹I-chTNT was well tolerated and can be used systemically or locally to treat refractory tumors of the lung.

Supported by MediPharm Biotech Co, Shanghai, China.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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