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%, compared to 22.5% 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% 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.
Dr. Kumar Prabhash, Professor and Head, Department of Medical Oncology, Tata Memorial Hospital, Mumbai, said, “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. K Govind Babu, Senior Medical Oncologist, HCG Hospital, Bengaluru, said, “The first study ‘BEST Trial’ conducted with Nimotuzumab at Kidwai Memorial Institute of Oncology, Bengaluru, showed encouraging results with 100% overall response rate. More than 50% patients were surviving at five years of follow up, who received Nimotuzumab in combination with concurrent chemoradiation. The long-term follow-up data from TATA study reinforces the findings in a large patient pool with significant survival outcomes at 10 years.”
Dr. Neera Gupta, General Manager, Medical Affairs & Clinical Development, Eris Lifesciences, said, “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 Nimotuzumab study supported earlier by Biocon and now Eris Lifesciences was an open-label, investigator-initiated, phase III randomized 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 randomized 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% compared to 22.5% 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 tumors 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.
