Biocon’s indigenous biologic for head & neck cancer a viable solution, say experts

New Delhi: A panel of leading oncologists at an event held in Delhi, focused on the evolution of cancer care treatment in India and highlighted the role of biosimilars and biologics in driving newer standards of testing and care in the country. The exchange of thoughts was a part of scientific session and a panel discussion organized by the Biocon on creating a paradigm shift in patient outcomes in cancer treatment through innovative targeted therapies.

In particular, the discussion which saw an exchange of views from an august panel of senior specialists including Dr G K Rath, Head, National Cancer Institute, AIIMS, focused on targeted therapies in Head and Neck Cancer, including the usage of Biocon’s novel Biologic – BioMab EGFR (Nimotuzumab).

The other participants on the panel included Dr Harit Chaturvedi, Director of Surgical Oncology, Max Super Speciality Hospital, Saket; Dr Kumar Prabash, Professor & Head Solid Unit, Medical Oncology, Tata Memorial Hospital; Dr Shyam Aggarwal, Senior Consultant, Medical Oncology, Sir Ganga Ram Hospital; Dr Vijay Anand Reddy, Senior Consultant – Clinical Oncology & Radiotherapy at Apollo Health City; Dr Sumit Goyal, Senior Consultant, Department of Medical Oncology at RGCI; Dr Atul Sharma, Professor, Medical Oncology, IRCH, AIIMS.

The panelists agreed that “Developments focused on accuracy and precision have improved quality of life for cancer patients. Dependence on targeted therapies proves that drugs specifically designed to target tumour cells, offer better efficacy, safety and tolerability and may eventually become the standard of care, bringing a paradigm shift in cancer management.”

Head & Neck cancer scenario in India

Head and neck cancers are a significant problem in our country constituting approximately one-third of all cancer cases, in contrast to 4-5 percent in the developed world. Paradoxically, however, management of these cancers is dictated by guidelines emanating from the West, with just a handful of seminal publications from India. Hence, there is a necessity to bring to the fore, novel treatments and interventions that address disease management and cure in the Indian context.

Biocon’s clinical study 

Against this backdrop, Biocon had developed a novel biologic in early 2000s and launched in India, its flagship Oncology Product BioMab EGFR (Nimotuzamab) for Head n Neck Cancer in 2006. The product has made a difference to several thousand patients so far and a new large scale investigator-led randomized clinical study at Tata Memorial Hospital has demonstrated the superior profile of this therapy leading to better patient outcomes for head and neck cancer patients.

Conducted with 536 patients from Tata Memorial Hospital, the results of this study, which were recently presented at the annual conference of the American Society of Clinical Oncologists (ASCO), evaluated the efficacy and safety of administering Nimotuzumab.

Among the largest randomized clinical studies on head and neck cancer, it proved how the introduction of this molecule, to the existing standard of care in patients of Head and Neck cancer, dramatically improved treatment outcomes on factors like progression-free survival, disease-free survival, duration of loco-regional control and overall survival.

Untill now the main management of Head and Neck Cancer was Chemotherapy + Radiation therapy however this study opens up a new improved way of managing Locally Advanced Head and Neck Cancer as it will now allow clinicians to add Biomab ( Nimotuzumab ) which is a targeted therapy to the current standard of Care (CRT). Biomab has a unique bivalent binding, because of which it binds primarily at the site of cancer cells where there is over expression of the EGFR protein. This is significant since this mechanism of action of Biomab ensures that only the cancerous cells are destroyed, unlike other targeted agents, ensuring that it does not cause additional toxicity.

Key results of the study:
• Improvement in median progression free survival by almost three times: Patients who were administered Biomab along with the usual chemo – radiation therapy, had survived without the disease progressing for almost three times more than patients who were only administered chemo-radiation.
• Reduction in risk of disease progression by 26 percent
• Reduction in grade 3-5 adverse events (except mucositis): This led to better compliance in the study, with no patient drop off due to severe side effects
• Significant improvement in Loco-regional control and disease free survival: Which means that further growth of tumour may get arrested

As per Biocon, at an additional scientific meeting of oncologists held at Chennai, 50 percent of the oncologists in attendance suggested said that these results are practice changing and they will like to add Nimotuzumab to current standard of Care (CRT) to all their patients of locally advanced Head and Neck Cancer.

Mr Suresh Subramanian, Senior Vice President & Head, Branded Formulations business – India and South Asia, Biocon said, “As the first company in India to successfully introduce a novel targeted anti-EGFR biologic, for the treatment of head and neck cancers, 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.”