Diagnostic innovation has grown vastly in the past few years, with Roche Diagnostics launching seven new tissue assays and label extensions, as well as two instrument launches in the United States in 2022 alone.
Katie Robertson, Ph.D., Roche Diagnostics’ disease area network lead for oncology, answered a few questions about how we’re addressing unmet patient and lab needs and helping to classify cancers, especially the more challenging ones. Robertson highlights investments in new testing – including companion diagnostics – and internal and external partnerships to accelerate access to new treatments for patients. She also provides a glimpse into our path forward in cancer diagnostics.
Labs have the same vision as we do – how do we benefit and give the most appropriate information and diagnostics to patients? Our latest two companion diagnostics (CDx), HER2-low and FOLR1, help identify the correct patient population and we have the new PRAME assay to increase confidence in diagnosing challenging cases. Laboratorians are thrilled, and of course they always want to know what else is happening, what does the future hold? It’s been great feedback and it’s really due to having more options for patients.
Melanoma is an aggressive skin cancer that originates from melanocytes from the cells in your skin and your eyes that contain melanin. The first test is H&E - hematoxylin and eosin – that will stain the patient’s tissue example. But what is interesting about melanoma is that not all melanomas are easily diagnosed using H&E alone.
There have been several studies that have suggested the detection of PRAME expression by immunohistochemistry (IHC) complements findings from the routinely used tests, and it enables a more informed clinical decision – and improved patient outcomes. This is not a CDx, like HER2-low. But in particularly challenging cases, if pathologists utilize the PRAME IHC, it can potentially highlight abnormal cells that express the PRAME protein, and pathologists will have more confidence in the diagnosis of melanoma.
Our HER2-low assay identifies metastatic breast cancer patients with low HER2 expression for whom ENHERTU® (fam-trastuzumab deruxtecan-nxki) may be considered a targeted treatment. It has received standing ovations at various conferences. In the past, there were no HER2-directed treatment options for more than 50% of patients with metastatic breast cancer who were considered HER2-negative. So thankfully, we have these advances in drug development that we’re able to target the lower range of HER2 expression and, of course, with the diagnostic innovations by Roche, these patients may qualify for new treatment that can lead to improved outcomes.
The folate receptor 1 protein, also known as the folate receptor alpha, is expressed in 35% of ovarian cancers. This is another amazing CDx test that aids in identifying epithelial ovarian cancer patients who are eligible for targeted treatment with ELAHERE™ (mirvetuximab). This is another great partnership – this time with Immunogen. This test informs clinicians of potential benefits from FOLR1 therapy. It’s another great example of our commitment to personalized healthcare through innovative solutions.
Digital pathology (DP) is one area of innovation that actually benefited from COVID-19. It’s one of the silver linings. With pathologists being out of the lab and at home, the healthcare industry had to figure out new solutions and how to treat patients outside the hospital.
One example of that is the newly launched DP 600, labeled for research use only. The benefit of the DP 600 is it can enable labs to provide high-volume and high-quality scanning necessary for digitization of their research workflows.
Digital pathology is certainly the way the future is going. There have been many DP studies with artificial intelligence (AI) that show the promise in advancing pathology imaging, which can benefit cancer patients through more precise diagnosis leading to targeted treatment.
The benefit of AI is that AI can count for you, and then there’s the pathologists who look at patterns, providing the best of both worlds. Manual scoring can take a while to make sure you are confident in excluding necrosis or folded tissues. Utilizing AI will speed up this process.
We also have a lot of new collaborations. For example, one of them is with Path AI. That will expand pathology access to AI-powered technology that will support CDx and drug development programs. We can’t do it alone, so we have a lot of partnerships that are going to benefit the patients in the long run with the research our digital portfolio is doing now.
We have a number of collaborations, not just pharma partnerships, but biotech companies and partnerships with companies involved in pre-analytics.
To drive innovation to meet the needs of patients and laboratories, we have to partner, whether that’s internal or external. That’s the only way we can achieve all of these milestones because everything is happening so fast. I don’t think one company, no matter how large, can do it alone. We can partner with different scientists and different healthcare companies to serve patients, especially those with hard-to-treat diseases.
Roche has more than 200 early-phase biomarker projects ongoing to advance our companion diagnostic pipeline.
One great example is gastric cancer, with new cases affecting about 26,500 people each year in the U.S. We have a collaboration with Astellas right now. They have two clinical trials – SPOTLIGHT and GLOW – used to investigate new treatments in gastric cancer. Astellas’ therapy for the SPOTLIGHT trial is zolbetuximab (IMAB362) plus mFOLFOX6, which is used for patients with HER2-negative, locally advanced, unresectable metastatic gastric or GEJ adenocarcinoma.
In both of these trials, 38% of the patients have Claudin 18.2 positive tumor expression greater than or equal to 75% of tumor cells with strong-to-moderate staining intensity. Using our assay, these patients in the trial are eligible for therapy. Potentially, 82,000 patients globally may be eligible for therapy based on the results of this CDx. It’s currently in phase 3 studies now, so looking forward to the endpoints and if all goes well, the next phase is to submit to the FDA. This is something really exciting for gastric cancer patients.
Disclaimer: This content is provided for educational and informational purposes only and does not constitute providing medical advice or professional services. The information provided should not be used for diagnosing or treating a health problem or disease, and those seeking personal medical advice should consult with a licensed physician. Always seek the advice of your doctor or another qualified health provider regarding a medical condition.
Katie Robertson, Ph.D., is a disease area network lead for oncology at Roche Diagnostics. She leads a team that provides disease area expertise and clinical input into medical strategies across pathology and sequencing for oncology.