India remains on track to become a major centre for clinical trials and should be routinely considered by international sponsors for global use of immune oncology (IO) therapies including immune checkpoint inhibitors in clinical care and clinical trials for solid tumours trials, highlights a recent IQVIA report.
Over the last decade, clinical data generated by Indian clinical sites have been used successfully to support drug approvals in the US, EU and elsewhere, the report said.
Breast, oral, cervical, lung, stomach, and colorectal cancers are the most common types of cancer reported in India.
WHO estimates 1.16 million new cases of cancer in India annually, with one in 10 people here developing the dreaded disease during their lifetime and one in 15 succumbing to the disease. By 2030 India may see an increase of more than 50% in cancer incidence, compared to 2012 data.
It is here IO therapeutics are driving a transformational change in cancer treatment, mobilising the patient’s immune system against their cancer, and aimed at reducing toxicities.
Substantial benefits have been observed with IO therapies for solid tumours – especially in advanced and metastatic cancers with limited treatment options – and these are increasingly being included in global cancer treatment guidelines as the standard of care.
Indian patients also often lack low-cost access to IO therapies that are approved in the US and European markets. These IO therapies are available either on-demand or on compassionate use as cost and affordability remain a concern even for higher-income group.
IO therapy in India is only reimbursed by medical insurance for patients who have been approved, and when used in combination with chemotherapy. In India, monoclonal antibodies and immunotherapy are covered from October 2020. Currently, an estimated 60-70% of patients must pay out of pocket for IO treatments, with 30-40% of cancer patients for whom IO therapy is an option receive some financial support from government agencies or via compassionate use programmes.
The reports notes that Indian regulatory authority is expediting new drug development process and ease of access to clinical trials with clear guidelines. Combination strategies for cancer treatment in India are also emerging, along with an ongoing quest to identify biomarkers to predict who will respond to therapy. Access to clinical trials to gain access to IO therapies are currently not available to the majority of cancer patients.
Therefore, the country needs to be included in major global IO trials, along with other APAC countries, including the many preclinical and clinical research studies underway in solid tumours.
The improved regulatory environment of the country that is now streamlined and simple has been highlighted as one of the major advantages. The country also has numerous government-funded and private cancer hospitals and research institutes with state-of-the-art facilities, which can support multi-centre clinical trials.
The report underscores that the presence of highly experienced and well-trained oncologists and other medical and surgical specialists, and trained English speaking investigators and clinical trial staff make the country a highly cost-effective location for clinical trials.
Prevalence and practice of globally accepted standards of care, which support the conduct of clinical trials based on international protocols, in addition to wide adoption of ICH-GCP guidelines, together with a large patient population with significant unmet needs make it a human study hub, says the report entitled: “India as a promising location for immuno-oncology trial.”