A study by Tata Memorial Hospital in Mumbai has shown that adding nimotuzumab to the standard treatment regimen significantly improves the 10-year overall survival rate for patients with locally advanced squamous cell carcinoma of the head and neck. The phase III study on 536 patients confirmed that nimotuzumab not only enhances progression-free survival but also maintains a good quality of life for long-term survivors, making it a potential therapeutic option in India.
Patients who received nimotuzumab with concurrent radiotherapy and cisplatin had a 10-year overall survival rate of 33.5%, compared to 22.5% for those who received only radiotherapy and cisplatin. The median overall survival improved from 2.78 years in the standard treatment arm to 3.69 years in the nimotuzumab arm. Additionally, there was no significant increase in late-term adverse events, underscoring the drug's safety and tolerability.
Head and neck cancers constitute a significant cancer burden in India, with over 65% of patients presenting with advanced disease requiring medical management. Currently, no other targeted therapy can be combined with concurrent chemoradiation with curative intent, marking this study as a substantial advancement.
Dr. Kumar Prabhash, Head of Medical Oncology at Tata Memorial Hospital, stated, “The findings of this study are promising for patients with head and neck cancer. Adding nimotuzumab to the existing therapy regimen significantly improves long-term survival rates while maintaining patient quality of life.” Dr. Neera Gupta of Eris Lifesciences emphasized the impact on patients' quality of life, noting that nimotuzumab improves progression-free and overall survival while preserving vital functions.
The study, initially supported by Biocon and now by Eris Lifesciences, was an open-label, investigator-initiated, phase III randomized trial conducted from 2012 to 2018. It found that nimotuzumab significantly improves long-term overall survival, particularly benefiting HPV-negative patients, without increasing the risk of long-term side effects. This represents a significant advancement in managing head and neck cancer in India.