I’m the Chief of medical oncology department at Santa Chiara Hospital in Trento (Italy) and I have the main expertise in the field of genitourinary cancers (mainly prostate) and non-small-cell lung cancers.
Could you explain the key benefits of utilizing treatment sequencing in oncology?
The sequential use of agents with either different mechanisms of action or ability to overcome some resistance mechanism today allows the clinicians to obtain the greatest clinical benefit (disease control) related to the availability of several active drugs.
In your opinion, how could real-world evidence (RWE) be used to help advance how we define the optimal therapeutic algorithm for different cancer types?
Today, the quick development of new agents is leading to a paradoxical landscape where the patients of everyday clinical practice are quite different from those enrolled in the pivotal trials, which led to the approval of the available agents. RWE represents the only chance to resolve the questions about the optimal sequences of these available agents. Furthermore, RWE is provided on the real population, which is seen every day in the ambulatory and which is quite different from that, highly selected, enrolled in the randomized clinical trials.
How can researchers/ the pharmaceutical industry effectively balance RWE with other sources of clinical trial data?
In the past RWE was considered of little value but today the scenario is different. The possibility to compare the outcomes observed in the clinical trials and the results of both Phase IV studies (which are mainly supported by the industry) and observational academic studies on sequencing strategies provides an unprecedented opportunity to test the true translation of the activity of each agent in the real clinical context.
Are there any alternative data sources, other than RWE, that aren’t currently be used but could be valuable in the future?
I think that a further opportunity is to share the industry data and RWE into big data analysis. In this view the role of blockchains could become crucial.
How do you envision the field moving forward in the next 5 years?
In this moment the landscape is liquid. The anticancer strategies after the development of an immunotherapy are not tailored, which acts only by removing the block of antitumor immune response (but it works only for about one quart of the patients), are experimenting a true tailored immune therapy. This could represent the next (definitive?) step in the anticancer war. In the meanwhile, the main challenge is to find effective biomarkers able to select the patients who have more probability to receive a clinical benefit.
The alliance between academic world and pharmaceutical companies is becoming mandatory in a historical period characterized by the contraction of economic resources to avoid money waste and the development of me-too drugs.