Biocon’s Novel Biologic Nimotuzumab combined with chemo-radiotherapy shows superior efficacy & safety over Standard of Care in a study on Head and Neck cancer patients in India
Mumbai & Bengaluru, India, June 4, 2018:
Biocon Ltd. (BSE code: 532523, NSE: BIOCON), Asia’s premier biopharmaceuticals company, announced today that a Tata Memorial Hospital (TMH), Mumbai team led by Dr Kumar Prabhash, Head, Solid Unit, Medical Oncology presented the results of a study with Biocon’s novel biologic molecule Nimotuzumab at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from June 1-5. This 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 study successfully met the primary endpoint of median progression free survival which was three times than that of standard of care.
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). The primary endpoint of the study was ‘progression free survival’, while other key secondary endpoints were ‘disease free survival’, ‘duration of loco-regional control’ and overall survival. The study successfully met the primary endpoint Median progression free survival of 60.3 months in NCRT arm as compared to 21 months in CRT arm which was statistically significant.
“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,Â for the treatment of head and neck cancers in India, the positive results from this large randomized study are a significant milestone in Biocon’s 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. We are pleased that ASCO has recognized the superior efficacy and safety profile of Nimotuzamab and the difference it can make in improving clinical outcomes of head and neck cancer patients by its addition to the standard of care.” said Suresh Subramanian, Senior Vice President & Head, Branded Formulations-India, Biocon.
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. Head and neck cancer 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*.
Dr Kumar Prabhash and his team has conducted this large patient study over a period of 6Â years to establish the superior profile of Nimotuzumab and the difference it can make to patients. The results also showed that the addition of Nimotuzumab to chemo-radiotherapy improved the locoregional control rate, disease free survival and had a trend towards improvement in overall survival.
*Source: 1. GLOBOCAN 2012 (IARC) Section of Cancer Surveillance. Available from: http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. [Last accessed on 2018 June 04].
About Tata Memorial Hospital
The Tata Memorial Hospital was initially commissioned by the Sir Dorabji Tata Trust on 28 February 1941 as a center with enduring value and a mission for concern for the Indian people. Current Director of the hospital is Dr. Rajendra A Badwe, who took over from for director Dr K. A. Dinshaw. The Tata Memorial Hospital is situated in Parel, Mumbai, in India. It is a specialist cancer treatment and research centre, closely associated with the Advanced Centre for Treatment, Research and Education in Cancer (ACTREC). The Centre is the national comprehensive cancer centre for the prevention, treatment, education and research in Cancer and is recognized as one of the leading cancer centres in this part of the world. Its a fully funded Grant-in-Aid Institution of Department of Atomic Energy, which also oversees the administration of institute since 1962.
The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) is a new state-of-the-art R&D satellite of the Tata Memorial Centre (TMC). It has the mandate to function as a national centre for treatment, education and research in cancer.
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully-integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners and healthcare systems across the globe. It has successfully developed and taken a range of Novel Biologics, Biosimilars, differentiated Small Molecules and affordable Recombinant Human Insulin and Analogs from ‘Lab to Market’. Some of its key brands are INSUGEN® (rh-insulin), BASALOG® (Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab), KRABEVA® (Bevacizumab) and ALZUMAb™ (Itolizumab), a ‘first in class’ anti-CD6 monoclonal antibody. The company has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oral insulin. archive.bioconbiologics.com follow-us on twitter: @bioconlimited