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A study by Tata Memorial Hospital in Mumbai has demonstrated that incorporating Nimotuzumab into the standard treatment for locally advanced squamous cell carcinoma of the head and neck significantly improves the 10-year overall survival rate.
In a press statement on Tuesday, the hospital informed that the Phase III study, which involved 536 patients, showed that Nimotuzumab not only enhances progression-free survival but also preserves a good quality of life for long-term survivors, positioning it as a promising therapeutic option for this type of cancer in India.
Patients treated with Nimotuzumab alongside concurrent radiotherapy and cisplatin showed a 10-year overall survival rate of 33.5 per cent, compared to 22.5 per cent 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. Importantly, the study reported no significant increase in late-term adverse events, underlining the drug's safety and tolerability.
Head and neck cancers account for one-third of the cancer burden in India, with over 65 per cent of patients presenting with advanced disease that is often unresectable, necessitating medical management. In the context of locally advanced disease, no other targeted therapy has shown the ability to combine effectively with concurrent chemoradiation with curative intent, marking this as a significant breakthrough in head and neck cancer treatment.
Kumar Prabhash, Professor and Head of the 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.”
Neera Gupta, General Manager of Medical Affairs & Clinical Development at Eris Lifesciences, expressed pride in supporting this pivotal study, saying, “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 the impact 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 study, initially supported by Biocon and now by Eris Lifesciences, was an open-label, investigator-initiated, Phase III randomised trial conducted from 2012 to 2018. It involved 536 adult patients and assessed the benefits of adding Nimotuzumab to the standard treatment of 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). With a median follow-up of 8.86 years, the long-term data revealed that the Nimotuzumab group had a 10-year survival rate of 33.5 per cent, compared to 22.5 per cent for the CRT group, indicating a significant improvement.
This benefit was particularly notable 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, especially benefiting HPV-negative patients.
With its proven efficacy and safety, this study marks a significant advancement in the fight against head and neck cancer in India.
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