Joaquín Casariego García-Lubén
Precision medicine is a term we are all familiar with in the industry, however its true meaning should not be underestimated.
Although its scientific basis is complex and is founded on an understanding that has taken many decades for the research community to uncover, it comes down to one very simple premise: that every patient is unique and requires bespoke medical care.
This is particularly true in oncology, where we are relentlessly undertaking research to help us uncover potential therapies which will target genes that have mutated or been altered. By focusing on the genetic make-up of the tumour itself when considering treatment pathways, we have the potential to see positive benefits in the clinical setting.
Developing transformational treatments
Finding solutions to the challenges we face in oncology, such as improving our understanding of the route for malignant tumour progression and early development, as well as meeting the needs of severely underserved patient populations, are my biggest driving ambitions.
For me, it’s a very personal challenge. Devastatingly, my father passed away this year due to cancer during the peak of the coronavirus pandemic in Spain. This tragedy has further strengthened my resolve to not rest until we, together as a community, can create a radically improved future for all oncology patients, their families and friends.
It is for people like my father, the hundreds of cancer patients I treated as a physician, and indeed my family, that I am so dedicated to my work every single day, both as a clinician and as a researcher. I am very much aware of my part in developing transformational and precise treatments that can improve people’s lives. To me, this means providing patients with the invaluable gift of more quality time: not just adding years to life, but also life to years.
Ultimately, I believe that precision medicine requires doing the right things, such as daring to innovate in more patient-centred research – and doing things right – by conducting research under the highest scientific, operational and ethical standards, while taking advantage of new technologies at our disposal.
In this endeavour to eradicate or intercept cancer, it is our duty to account for distinct differences in people’s ‘-omics’ spectrum, but also importantly in their clinical, psychosocial and professional environments, while also considering unique lifestyle-related factors. All of which interact in one way or another, in every patient, linking subpopulations with similar features and so, prognosis and outcomes.
Through my work at Janssen I am privileged to be part of a company that is driven by the premise of providing personalised treatment solutions in cancer care. Across our solid tumours portfolio, we are confident that our approach to precision medicine will deliver significant societal value, by optimising patient care through improving disease prevention, diagnosis and treatment.
As I see it, precision medicine is truly an evolution where we are dedicated to moving away from a disease-focused model, so that we can translate technological advances into more patient-centred benefits.
Powering precision medicine
Biomarkers are well known in the oncology space and as a company we are determinedly pioneering research in areas where patients currently face poor clinical outcomes, such as those living with urothelial carcinoma (UC), the most common type of bladder cancer.
I am particularly proud of our achievements in this area, where we were the very first company to receive FDA approval for a fibroblast growth factor receptor (FGFR) inhibitor in advanced and metastatic bladder cancer harbouring an FGFR alteration, addressing the considerable unmet need for patients living with this disease.
Not only are we exploring this in bladder cancer, but we are also investigating a multitude of solid tumour types that bear these genetic aberrations so that a wider range of patients could potentially benefit from this research.
Furthermore, by following a similar trajectory in the treatment of non-small cell lung cancer (NSCLC), where we are studying specific alterations in the epidermal growth factor receptor (EGFR), we endeavour to provide options to a heavily underserved patient population.
Our teams of clinical researchers are unrelenting in their efforts to deliver data to support the treatment of patients who have NSCLC expressing exon 20 insertion mutations in the EGFR gene, who have extremely limited options currently, while also developing treatments to bring practice changing results.
In addition, DNA repair defects (DRD) such as BRCA- 1/2 or ATM mutations present in advanced- and late-stage prostate cancer represent a key focus for Janssen in complementing the continuum of targeted therapies now available to prostate cancer patients, including PARP inhibitors.
It’s my firm belief that advances in all these research areas may provide important outcomes for patients living with these deadly diseases, and help to address one of the most pressing health challenges that exists: achieving long-duration and high-quality cancer survivorship.
Tailored solutions for patients
The patients of today are certainly more empowered and better-informed than ever before. I see examples of this every single day, and at Janssen we are devoted to ensuring that patients inform our every step, from providing input into the design
of our clinical trials, right through to our disease area strategies. An important element in ensuring treatments reach the right patients, at the right time and for the right outcome, when biomarkers play a critical role in patient outcomes, is through using a companion diagnostic. I am excited to see first-hand how, at Janssen, we are working to shape the personalised healthcare spectrum through accurate testing in the clinical setting.
The right test, performed at the right time, not only benefits patients directly but also helps to support healthcare systems by allowing medications to be used in the most appropriate patient populations and in an efficient way, from a resource perspective.
That’s why, in collaboration with our strategic industry partners, we are pursuing biomarker testing to accurately identify patients whose tumours harbour FGFR alterations, ensuring they receive appropriate treatments tailored to their needs. This, in turn, will help to guide treatment decisions in the clinical setting.
We are following a similar approach in lung cancer through an ongoing partnership to pursue a molecular diagnostic strategy for our early-stage investigational EGFR-MET bispecific antibody, which is being studied in the treatment of NSCLC.
Similarly, DRD testing in late stage prostate cancer is needed to identify patients who could potentially benefit from PARP inhibition. Through use of these diagnostics, we can limit inefficient use of healthcare resources and direct these back to where they truly matter – patient outcomes.
I am constantly impressed by the tireless endeavours of our biomarker scientists who
are also working to create tests that detect the presence of androgen receptor (AR) abnormalities for people living with prostate cancer.
These tests are designed to detect multiple biomarker changes simultaneously, and efforts are ongoing to understand the changes that occur in circulating tumour cells (CTCs) as a result. This ongoing research will undoubtedly help us to better understand the development of prostate cancer at the molecular level, so that we can move towards more personalised treatments in this space, as well as in bladder and lung cancers.
Pushing the boundaries
Janssen’s precision medicine research, supplemented by new technologies such as Artificial Intelligence (AI), is pushing the boundaries of what we previously thought possible. We are working to make this beneficial for the patients of the future, by combining with big data collected from patients with a long- duration disease course.
This is exciting for a number of reasons, not least the potential to reformulate our understanding of the impact of different diagnostics and treatment approaches in clinical practice. More specifically, through our ORACULUM studies, we are using AI to analyse patient-level data that is collected through electronic health records across numerous countries in Europe, the Middle East and Africa.
This will give us the opportunity to inform the wider scientific community on new hypotheses for future trials. I firmly believe that, with the help of like-minded strategic partners and groundbreaking technological advances such as these, we are making huge strides on our combined journey towards changing what a cancer diagnosis means for the patients of today and tomorrow.
With the evolving focus on precision medicine comes a great deal of change for the pharmaceutical industry, and vitally hinges on resilient, cross-industry partnerships. I strongly believe in the power of collaboration and our alliances take many forms, but our goal is always the same: to advance scientific research which has the prospects to deliver solutions that provide value to patients, physicians, payers and society as a whole.
Through this combined, robust approach I am optimistic that, as an industry, we will revolutionise the way we treat cancer and pave the way for the precision medicine of the future.
I look forward to a time when our ambitions to make cancer a manageable condition can become a reality, both for patients like my father and for their families – because time has a wonderful way of showing us what really matters.