Mumbai, Feb 03: A study conducted by doctors at Tata Memorial Hospital, Mumbai, has shown promising results using immunotherapy instead of physician’s-choice standard chemotherapy in patients with relapsed cancer.
The study found that an ultra-low dose of the immunotherapy drug nivolumab can help patients with relapsed solid tumours or advanced cancer live longer, experience a better quality of life, and dramatically reduce treatment costs.
Study design and scope
In this Phase III randomised clinical trial, around 500 patients with relapsed solid tumours were enrolled between June 2020 and February 2024. Patients were randomly assigned to receive either standard chemotherapy or ultra-low-dose nivolumab (20 mg every two weeks). This dose is significantly lower than the nivolumab dosage currently approved and used worldwide.
The study included patients with head and neck cancer, lung cancer, oesophageal cancer, bladder cancer, and other solid tumours, including some with specific genetic features. All participants had cancer that had returned or progressed after previous treatment.
Key findings
The results were striking. Patients who received ultra-low-dose nivolumab lived longer than those treated with chemotherapy. They also reported a better quality of life, with fewer severe side effects. Importantly, fewer patients required hospital admission due to treatment-related complications, a critical consideration for individuals with advanced disease.
Cost and access implications
This matters because access to immunotherapy is extremely limited in many parts of the world. In some hospitals, fewer than 3% of eligible cancer patients are able to receive these life-extending drugs because of cost.
As per the study, standard-dose nivolumab costs approximately ₹4.4 lakh per month, placing it far beyond the reach of most patients. In contrast, ultra-low-dose nivolumab costs about ₹37,000 per month, resulting in treatment cost reductions of up to 90%.
Expert opinion
Dr Kumar Prabhash, Professor of Medical Oncology at Tata Memorial Hospital and one of the lead authors of the study, said that using an ultra-low dose of just 20 mg—one-tenth of the standard 240 mg dose—brings down treatment costs substantially.
“The study will help patients from lower-income groups access cancer treatment under government health insurance schemes,” Dr Prabhash said.
He added that immunotherapy is currently used mainly for advanced-stage cancer, but ongoing studies are also exploring its use in early, localised stages of the disease.
No loss of effectiveness
Importantly, the study found no loss of effectiveness with the lower dose. While tumour shrinkage rates were similar between the two groups, patients receiving nivolumab had better overall survival—a pattern already observed with immune-based therapies.
Researchers said these findings challenge the long-held belief that higher drug doses necessarily lead to better outcomes. Instead, they argue that smarter dose selection could improve survival, reduce side effects, and significantly lower costs.
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How immunotherapy works
Immunotherapy works by using the body’s own immune system to fight disease rather than attacking cancer cells directly. It boosts, trains, or redirects the immune response when it fails to recognise cancer or becomes suppressed.
Checkpoint proteins normally act as brakes on T cells, preventing the immune system from attacking healthy cells. Cancer cells exploit this mechanism to escape immune attack.
Nivolumab works by removing this braking effect, allowing T cells to remain active and recognise and destroy cancer cells—though this enhanced immune response can sometimes lead to side effects.
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