Immuno-oncology (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 standard of care.
Use of IO therapies – including immune checkpoint inhibitors – in clinical care and clinical trials for solid tumours are being increasingly considered.
Need for improved access
Indian patients also often lack low-cost access to IO therapies that are approved in US and European markets. Currently, while IO therapies are available in India – either on demand or on compassionate use grounds – cost and affordability remain a concern even for higher income groups (see Figure 1). IO therapy in India is only reimbursed by medical insurance for patients who have been approved, and when used in combination with chemotherapy. In future, it would be helpful if the reimbursement decisions of insurance companies could take account of multiple factors, including overall survival benefit, efficiency, value, drug approval status, magnitude of clinical benefit and improved quality of life. In India, monoclonal antibodies and immunotherapy will be 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 receiving some financial support from organizations such as government agencies or via compassionate use programmes.
Recent moves by the Indian regulatory authority to expedite the new drug development process and ease of access to clinical trials have potential to help address access issues, along with the availability of 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 – another way to gain access to IO therapies – is also currently not available to the majority of cancer patients in India. This situation demands solutions. India should be included in major global IO trials, along with other APAC countries, including the many preclinical and clinical research studies underway in solid tumours. In addition to providing robust data on safety, efficacy, and treatment approaches, this would benefit India’s large cancer patient population.
Trial recruitment challenges
In India, there are minimal challenges in patient recruitment for IO clinical trials from the ethical, regulatory and institutional review board perspectives. Oncologists – including those involved in this advisory board meeting – have strong support teams available to coordinate clinical trial activities, along with access to a large pool of patients, many of whom would be interested in participating in trials.
However, there may be challenges for potential participants in meeting inclusion criteria, due to elements such as comorbid conditions, the existence of infections, and ongoing steroid and/or antibiotic use. Long-distance travel to clinical sites might also be a limiting factor.
During biomarker testing, patient anxiety, lack of standardisation among laboratories, and small tissue samples are the commonest hurdles faced by treating oncologists.
One approach to overcoming these challenges would be to create a central platform including details about oncology patients, treatment options, and clinical trial opportunities. This could take the form of a database, application or registry, which could help to increase awareness among doctors and patients, thereby increase participation in clinical trial across India.
There is a particular need to connect rural patients and hospitals with major tertiary urban oncology centres and principal investigators.
Closing the gap
The advisory board proposed several approaches to closing the gap between levels of access to IO trials and treatment in India and those in other countries:
• Exploring and showcasing India’s capabilities in oncology clinical trials and treatment with global regulatory agencies and medical societies, focusing on areas such as the ethics committee, data quality and infrastructure, and highlighting the need for improved patient access.
• Organizing continuing medical education (CME) events through bodies such as the Immuno-Oncology Society of India, advisory boards, and national and international conferences.
• Establishing platforms to conduct regular training sessions for oncologists, researchers and site staff on IO treatments, guidelines, adverse event management, and conducting GCP-compliant clinical trials (including setting up robust quality assurance teams).
• Developing structured treatment protocols for hospitals as a basis for research and high quality data collection. These should be frequently updated to include the latest global guidelines and recommendations.
• Setting up a central registry platform for oncology patients, including updates on clinical trials and treatments, and educational materials for oncologists, researchers, site staff and patients. The goal will be to foster clinical trial participation across India.
• Creating online awareness and mobile applications to educate patients and caregivers about recent advances and ongoing trials.
• Discussions are underway between medical and government policymakers for immunotherapies to receive reimbursement coverage by insurance companies and for local government health policies which could be implemented in the near future for the benefit of patients.
Over the last decade, clinical data generated by Indian clinical sites have been used successfully to support drug approvals in the United States, European Union and elsewhere. India remains on track to become a major centre for clinical trials and should be routinely considered by international sponsors for global IO trials. Advantages of India as a base for such trials include:
• An improved regulatory environment that is now streamlined, simple and structured
• Numerous government-funded and private cancer hospitals and research institutes with state-of-the-art facilities, which can support multi-centre clinical trials
• Experienced and highly trained oncologists and other medical and surgical specialists
• Trained English-speaking investigators and clinical trial staff
• Potential as a highly cost-effective location for clinical trials
• Prevalence and practice of globally accepted standards of care, which support conduct of clinical trials based on international protocols.
The author is Medical Director-Oncology, Medical Science and Strategy Asia, IQVIA.