Bruno Jolain, Director – Medical, Roche Products (India) explains the growing importance of liquid biopsies in cancer care and its potential to improve diagnostic and treatment outcomes. He also shares more details about FoundationOne Liquid CDx, a pan-tumour liquid biopsy test which was recently launched in India, in an interaction with Lakshmipriya Nair
How is liquid biopsy ushering new approaches in cancer diagnostics and care? How can it bring in improved impact patient management and enhance patient-centricity in diagnostics?
A liquid biopsy is a sample of human liquid which will undergo molecular testing to assist in the management of patients with malignant diseases. A liquid biopsy-based Comprehensive Genomic Profiling (CGP) test requires a patient’s blood sample, rather than a sample of their tumour tissue. Next-generation sequencing (NGS) is then used to analyse circulating tumour DNA in the blood sample, to provide insights into what is driving the growth of the patient’s tumour.
Liquid biopsies are becoming an increasingly important option to make informed personalised treatment decisions for patients with advanced cancer, especially those who wouldn’t normally be eligible for genomic testing because of their health, cancer type or tumour location.
It is a simple and minimally invasive procedure for obtaining a sample – a single blood draw – and offers a quick, convenient option that can be performed in the out-patient setting. This means patients do not have to travel to hospitals or large medical centres for the test and may help reduce requirements for healthcare infrastructure and resources compared with tissue-based testing.
The simplicity of the testing procedure also enables treatment decisions to be made faster. This is particularly advantageous to patients with advanced cancer who may need to be treated quickly. It may also help to avoid the distress associated with waiting for biopsies to be scheduled and receiving the results of tissue-based testing.
What are the current gaps in cancer detection that can be filled by liquid biopsy and what are the complications it can help avoid?
In addition to aspects mentioned above, in many cancer patients, tissue biopsy is not possible or recommended, because the tumour is inaccessible, sometimes, the tissue obtained from the biopsy is insufficient to proceed with CGP, or when preferred because of patient convenience. This method of genomic testing, being less invasive than a tissue biopsy, means more patients can benefit from the insights of CGP. A relevant statistic for example is, around one-third of patients with non-small cell lung cancer (NSCLC) do not have adequate tissue available at diagnosis for tissue-based genomic testing. This along with the increased risk of rapid disease progression, means that a quick and convenient liquid-based approach could be particularly beneficial for these patients.
Can it become a standard clinical tool and replace tissue biopsies? Why?
We believe that determining a treatment plan for patients with advanced solid tumours should start with CGP at diagnosis, whether it is tissue-based or blood-based.
Liquid biopsy tests complement solid tissue biopsy tests, enabling CGP in patients when a tissue biopsy is not possible or recommended. For example, if the tumour is inaccessible, when there is insufficient tissue, or when preferred because of patient convenience.
There are a number of situations where liquid biopsies might be particularly beneficial, for example:
- The improved feasibility of repeat biopsy via liquid biopsy (i.e. taking another blood sample) may also allow more frequent testing to detect signs of disease progression or early recurrence of cancer.
- Liquid biopsy-based tests may also offer advantages for assessing tumour heterogeneity. As cancer is a dynamic disease, tumours often contain a diverse collection of cells harbouring distinct molecular signatures that convey different levels of sensitivity to treatment. Tissue samples may not be representative of all the different cell types within a patient’s cancer, whereas a blood sample can provide a more complete overview.
Roche Pharma recently launched a liquid biopsy test for patients with solid tumours in India. Can you explain how the technology works? Tell us about its clinical potential?
Roche recently launched the US-FDA Approved Foundation Medicine’s FoundationOne Liquid CDx, a pan-tumour liquid biopsy genomic test for late-stage cancer patients in India. This is the first FDA approved test that can analyse more than 300 genes and multiple genomic signatures to optimise patient care. This test utilises next-generation sequencing to analyse the four main classes of genomic alterations in more than 300 cancer-related genes. A simple way to visualise this will be that in contrast to the conventional methods of performing a genetic test for one gene at a time this test performs a much more enhanced analysis by parallel sequencing of 300 plus cancer-related genes at the same time for all kinds of genomic alterations that may be present in these genes. The results from this test are delivered in an integrated report that identifies alterations matched to FDA-approved therapies and provides relevant clinical trial information.
The test provides further validity and potential benefits to the clinicians as well as the patients by identifying mutations and subsequent treatment options. It also has companion diagnostic labels. A companion diagnostic helps identify patients who may benefit from a certain treatment. For example, in certain prostate and lung cancer therapies, including Rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor for treatment in patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase (TKI) inhibitors for the treatment of patients with non-small cell lung cancer (NSCLC).
By incorporating multiple genes, including several companion diagnostic biomarkers, the test can help save time versus sequential biomarker testing. Moreover, FDA-approved tests are preferred by biopharma companies developing precision therapeutics to enable accelerated companion diagnostic development.
FoundationOne Liquid CDx covers guideline-recommended and other clinically relevant genomic alterations for multiple solid tumour types, including NSCLC, breast, ovarian, prostate, and rare cancers such as cancer of unknown primary. The test also reports relevant genomic alterations, which could support clinical decision making for patients with solid tumours, irrespective of the tumour’s location in the body, an approach known as tumour-agnostic therapies.
How cost-effective is this technology, as India is a cost-sensitive market?
At Roche, pricing is arrived at by taking into consideration the value we bring to the patients and society and ensuring access for patients in need. Roche has introduced multiple patient support programs to enhance access to innovative life-saving medicines in India. Similarly, Roche has also launched FoundationHOPE, a patient support programme to enhance access to Foundation Medicine profiling services in India by providing financial assistance to eligible patient/caregiver basis their socio-economic evaluation.
Further, Roche is committed to working with governments, regulators, physicians, pathologists and healthcare professionals to ensure that quality testing and effective medicines are available to patients who need them around the world and that affordability is not a barrier to access.
What are the unique benefits it can offer Indian patients since the country has a sizeable and growing burden of cancer?
The biggest advantage is the simplicity of the testing procedure– a single blood draw –which means patients do not have to travel to hospitals or large medical centres for the test. Roche offers mobile blood draw facility for patients eligible for FoundationOne Liquid CDx in India to collect the sample from their home or most convenient location. This reduces the inconvenience and cost associated with travel for the patients. It may in future, help reduce requirements for healthcare infrastructure and resources compared with tissue-based testing. In one of the studies reported in 2013, in India locally advanced cancer of the cervix, of the 144 patients evaluated, 88 could not complete the treatment, and 63.89 per cent were not able to travel more than 100 km from home to hospital for their treatment.