Nimotuzumab boosts survival rates in head & neck cancer: Tata Memorial study

New Delhi: A recent study by Tata Memorial Hospital in Mumbai reveals that the addition of 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.

This Phase III study, conducted on 536 patients, found that Nimotuzumab not only enhances progression-free survival but also maintains a good quality of life for long-term survivors, making it a promising therapeutic option for this disease in India.

The study shows that patients who received Nimotuzumab alongside 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 increased from 2.78 years in the standard treatment group to 3.69 years in the Nimotuzumab group. Notably, there was no significant increase in late-term adverse events, underscoring the safety and tolerability of Nimotuzumab.

Dr. Kumar Prabhash, Professor and Head, Department of Medical Oncology at Tata Memorial Hospital, stated, “The findings of this study are promising for patients with head and neck cancer. By adding Nimotuzumab to the existing therapy regimen, we have noticed a significant rise in long-term survival rates while maintaining patient quality of life.”

Dr. Neera Gupta, General Manager of Medical Affairs & Clinical Development at Eris Lifesciences, commented, “We are proud to have supported this pivotal study that brings new hope for patients with head and neck cancer. These patients frequently experience a compromised quality of life due to impacts on vital functions, including speaking and swallowing. The findings show that adding Nimotuzumab to concurrent chemoradiation improves progression-free survival and overall survival while also preserving quality of life.”

The Nimotuzumab 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 involved 536 adult patients and evaluated the benefits of adding Nimotuzumab to standard treatment (chemotherapy and radiation) for locally advanced head and neck squamous cell carcinoma (LA HNSCC). Patients were randomized to receive either radical radiotherapy with weekly cisplatin (CRT) or the same regimen plus weekly Nimotuzumab (NCRT). 

The long-term follow-up data, with a median follow-up of 8.86 years, showed that patients who received NCRT had a significantly higher 10-year survival rate of 33.5% compared to 22.5% for those who received CRT alone. Importantly, the addition of Nimotuzumab did not increase the risk of long-term side effects, particularly benefiting HPV-negative patients. 

Head and neck cancers represent one-third of the cancer burden in India, with more than 65% of patients presenting with loco-regional advanced disease that often requires medical management. In this context, the study marks a significant advancement, as no other targeted therapy can be combined with concurrent chemoradiation with the intent to cure in the locally advanced setting.