I am sure we all have been or will be touched by cancer at some level, at some point in our lives. Perhaps we have had a relative, a friend or a colleague, whose life has been affected by cancer – an incurable and devastating disease that has no mercy on anyone.
Despite a substantial amount of resources being invested in cancer research world-wide and the many phenomenal advances made so far, we have unfortunately not yet been able to fully combat this calamity that keeps devastating so many lives. Cancer remains one of the leading causes of death globally.
Conventional cancer treatments, such as cytotoxic therapy, are based on a “one size fits all” approach. Such treatments lead to ongoing issues, including drug resistance, low target selectivity, ineffective management of metastatic disease and severe side effects. Cancer is a highly heterogenous disease and active immune responses play the main role in clonal survival and therapy resistance.
Immuno-Oncology and clinical trials
The rapidly expanding field of Immuno-Oncology (IO) has emerged as a novel therapeutic area within the Oncology ecosystem, revolutionizing cancer treatment. Several lines of evidence have proven immunotherapy to be a more effective way to treat cancer patients compared to the currently available conventional cancer treatments.
Immunotherapy stimulates the body’s own immune system to target and attack the tumor, which is otherwise invisible to, or inhibiting the immune response. One of the benefits with immunotherapy is that it only targets the immune cells in the body without having any effect on healthy cells. However, an overactivation of the immune system might occur, leading to autoimmune diseases. Generally, the responses to immunotherapy are believed to be more durable, meaning an overall improved patient outcome and a longer survival rate for cancer patients.
During the past years, IO clinical trials have increased, and a wide range of new investigational agents have been added to the IO pipeline in clinical development. Although the COVID-19 pandemic had a negative impact on the conduct of IO trials last spring, an increase in IO trials has taken place.
According to cancerresearch.org, 4,720 IO agents were identified in August 2020, representing a growth rate of 233% since 2017 and 22% compared to 2019. These IO investigational agents are represented all the way from the preclinical stage to treatments approved by regulatory authorities. It is worth keeping in mind that out of this substantial number of investigational agents, only a very small portion has made its way to cancer patients. Furthermore, seeking to improve clinical response rates, novel combination regimens are also being investigated.
In general, Oncology trials differ from other trials due to their complex nature. There are various challenges associated with immunotherapy, including a lack of knowledge concerning mechanism of action, the need for further investigation of predictive biomarkers, poor preclinical models and several different obstacles related to clinical trials as such, as well as issues related to regulations and ethical standards.
Oncology trials, particularly IO trials, are highly complex and often face difficulties in patient enrollment, prolonging the timelines for the trial by years in some cases, which in turn causes delays of treatment delivery to patients, as well as higher costs for the sponsor.
Another challenge that immunotherapy is faced with is the existence of inequalities in healthcare systems. Even though there are several approved immunotherapies on the market, often our healthcare and reimbursement systems do not allow for a complete utilization of these drugs. Unfortunately, not everyone can afford the currently available immunotherapies due to the high costs associated with them. Therefore, a change in our systems is desired.
Clinical Research: To better understand immunotherapy and broaden the field of IO, a genuine effort is needed to enhance basic research and increase the number of clinical trials. Only through clinical trials will we be able to ensure the delivery of new immunotherapies to cancer patients.
Collaboration: Different parties including researchers, the pharma industry, healthcare professionals, regulatory bodies and decision-makers need to come together in order to invent cutting-edge, high quality treatment paths for cancer patients. Reducing the burden of cancer on our nations and societies will be achieved through collaboration and a strong commitment to enhancing research and clinical trial conduct.
Patients, the center of attention: Treating cancer patients with revolutionary medical solutions has a positive impact not only on the lives of patients and their relatives, but also on the entire society. The better and sooner cancer patients are treated, the faster they can return to their normal lives and social duties.
Cancer patients deserve a meaningful life. The fight against cancer requires a genuine commitment to science and giving equal opportunities for cancer patients to have access to novel treatments.
-Veronica Kalhori, PhD (Oncology)
Communications and Brand Manager