FM November2020 Digital P

clinical trials
ACCESS TO IMMUNO-ONCO DRUGS
India is a promising location for immuno-oncology trials
DR ANJU GOPAN
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
IN INDIA, THERE ARE
MINIMAL CHALLENGES IN
PATIENT RECRUITMENT FOR
IO CLINICAL TRIALS FROM
THE ETHICAL, REGULATORY
AND INSTITUTIONAL REVIEW
BOARD PERSPECTIVES
IO THERAPY:
CHALLENGES
Potential issues faced for
immunotherapy treatments in
India as per KOLs
Expensive
Treatment
Insurance
Approval
40% 60%
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
November 2020 / FUTURE MEDICINE / 77