ONCOLOGY-BASED THERAPY
Have there been any particular challenges that have affected the development and/or clinical trials for oncology-based therapies? One of the biggest challenges right now, beyond the impact of COVID-19, is the reliance on overall survival (OS) data as the way in which value is assigned to cancer medicines. The challenge we are facing is that, as patient outcomes continue to improve – thanks in large part to new innovations – the ability to show significant OS differences within the timeframe of a clinical trial becomes increasingly unrealistic in some tumour types and in earlier lines of therapy. In multiple myeloma, for example, patient survival and response to treatments have improved drastically versus 20 or 30 years previously, where only 50% of patients were living three years. We are now seeing overall survival that extends to five or even 10 years. While this progress is great news for people living with multiple myeloma, the continued requirement for mature OS data means they are currently waiting too long to access treatments they could already be benefiting from, even when those treatments have been approved by regulatory agencies.
Instead of waiting for OS data, we should work with all stakeholders to establish alternative end points and more flexible methods to measure the efficacy of new cancer therapies while overall survival data matures. For example, in multiple myeloma, we could be using minimal residual disease (MRD) negativity as a surrogate marker for measuring patients’ survival outcomes and end points in clinical trials. We also need to consider how we can demonstrate improvements in patient- reported outcomes to determine whether a particular compound is of benefit to patients. What’s most important is to agree on outcome measures that are meaningful to patients and physicians and to start these discussions early. There is also the need to generate enough scientific evidence to support the relationship between surrogates for OS in the long term, and for regulators and payers to accept these data as efficacy outcomes. This is where enhancing infrastructures to improve how we gather and use real-world data becomes more and more important.
From your experience, what can clinical research organisations (CROs) do better in order to improve the quality of both the development and clinical trial process of oncology trials?
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We need to design monitoring around the patients’ schedules and consider what can be done virtually to reduce the necessity for hours upon hours of hospital visits. Where hospitalisation is required, we could find ways to have patients admitted to local facilities, rather than at the study centre where it may be burdensome for patients to travel to, or where they may be without their support network. Improving the quality of trials is all about challenging ourselves to rethink how we execute or operationalise our clinical trials from the perspective of patients, rather than that of the study sponsor. This means considering the entire experience of the patient, so that we are asking ourselves: how does this fit into the patient’s life? Are we doing everything we can to make participation in these trials convenient for patients? This will require all stakeholders – academics, pharmaceutical companies, patient advocacy groups, and regulators to rethink how we run oncology studies to provide the measurement and monitoring to the high standards required, but with a heightened consideration for the patient.
Going forward, what are you most excited about in the field of oncology? Despite the incredible work of the oncology community across Europe, cancer remains one of the leading causes of premature death in the region. I am motivated by the hope that through continued advances in our understanding of cancer and ongoing scientific innovation, we can change what a cancer diagnosis means to patients and their families, and reduce these statistics drastically. Innovations like CAR-T are particularly exciting. We have been investigating the potential of CAR-T therapy in patients with relapsed and refractory multiple myeloma, but we may only just be scratching the surface of what this technology could mean for cancer treatment in the future. Exploring CAR-T therapy in other oncological tumours, or in earlier lines of treatment, may give us better insight into its potential for long-term disease control, or may one day potentially even be a cure. I also look forward to developing our compounds, or thinking about combination regimens with newer therapies, where we could provide physicians with options that are more flexible and more tailored to patients’ specific medical characteristics and personal preferences.
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