Tata Memorial study finds Nimotuzumab increases survival in head and neck cancer

A study conducted 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 results of the Phase III study on 536 patients confirmed that Nimotuzumab not only improves progression-free survival but also maintains a good quality of life for long-term survivors, making it a potential therapeutic choice for this disease in India.

 Patients with head and neck cancer who received Nimotuzumab in combination with concurrent radiotherapy and cisplatin had a 10-year overall survival rate of 33.5 per cent, compared to 22.5 per cent 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. Furthermore, the study found no significant increase in late-term adverse events, highlighting the safety and tolerability of Nimotuzumab.

 Head and neck cancers account for one-third of the cancer burden in India with more than 65 per cent of patients presenting with loco-regional advanced disease that is often unresectable and necessitates medical management. In the locally advanced setting, no other targeted therapy can be combined with concurrent chemoradiation with the intent to cure, making this a significant advancement in the management of head and neck cancer.

The Nimotuzumab study supported earlier by Biocon and now Eris Lifesciences was an open-label, investigator-initiated, phase III randomised trial conducted from 2012 to 2018, involving 536 adult patients. It 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 randomised to receive either radical radiotherapy with weekly cisplatin (CRT) or the same regimen plus weekly nimotuzumab (NCRT). The long-term follow-up data evaluated 10-year overall survival, with a median follow-up of 8.86 years. The study found that patients who received the weekly nimotuzumab (NCRT) lived longer overall, with a 10-year survival rate of 33.5 per cent compared to 22.5 per cent for those who received standard (CRT) treatment alone, indicating a significant improvement with nimotuzumab addition. Importantly, adding nimotuzumab did not increase the risk of long-term side effects.

 This benefit was particularly noticeable in patients whose tumours were not caused by the human papillomavirus (HPV). The study concluded that nimotuzumab enhances long-term overall survival without increasing late-term adverse events, particularly benefiting HPV-negative patients.

 This study, with its demonstrated efficacy and safety, offers a significant advancement in the fight against head and neck cancer in India. Eris Lifesciences is committed to providing effective treatment solutions to ensure better health and well-being for patients with head and neck cancer.