Tata Memorial Hospital Mumbai presented the results of a study with Biocon’s novel biologic molecule Nimotuzumab indicating its superior efficacy and safety over Standard of Care in a study on Head and Neck cancer patients in India at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from June 1 to 5.
The 536- patient study was conducted by Dr. Vanita Noronha, Dr. Amit Joshi, Dr. Vijay Patil, Dr. A. K. D’cruz, Dr. Sarbani Lasker, Dr. J. P. Agarwal with Dr. Kumar Prabash as the lead investigator, over a period of 6 years. The results showed that the addition of Nimotuzumab to chemo-radiotherapy improved the loco-regional control rate, disease free survival and had a trend towards improvement in overall survival.
The investigator-initiated study, one of the largest randomized clinical studies on head and neck cancer patients in India, evaluated the efficacy and safety of administering Nimotuzumab during concurrent chemo-radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). Adult patients of LAHNSCC were randomized 1:1 into either radical radiotherapy with weekly cisplatin (CRT arm) or the same schedule of chemo-radiation with weekly Nimotuzumab (NCRT arm).
“We believe Nimotuzumab, will benefit a large number of head and neck cancer patients in India. Nimotuzumab with chemo-radiotherapy will provide an alternate therapeutic option in the armamentarium against locally advanced head and neck cancer,” said Principal investigator, Dr Kumar Prabhash, Head, Solid Unit, Medical Oncology, TMH.
“As the first company in India to successfully introduce a novel targeted anti-EGFR biologic, for the treatment of head and neck cancers in India, the positive results from this large randomized study are a significant milestone in our ongoing efforts to establish Nimotuzumab’s ‘best-in-class’ status for the treatment of one of the most common forms of cancer in the country,” said Suresh Subramanian, Senior Vice President & Head, Branded Formulations-India, Biocon.
Head and Neck is one of the leading cancers in India. Over 16 new patients are diagnosed with this specific cancer every hour in India, and 12 deaths recorded every hour.
Nimotuzumab is the first indigenously produced novel biologic developed by Biocon and introduced in India as BIOMAb EGFR for head and neck cancer in 2006.