Evaluating the Oncology Landscape: Diagnosis, Treatment, Predictions

January 02, 2024 - Over the past decade, advancements in the oncology landscape have significantly changed the diagnostic pathway and treatment pipeline. As scientific discoveries inform product development and care strategies, experts predict that the industry will continue to evolve,  and prioritizing early diagnosis and treatment.

LifeSciencesIntelligence sat down with Candice Del Rio, MS, BSN, RN, Director of Clinical Operations at Curavit, and Julie Ozier, Senior Vice President of IRB Review at Advarra, to discuss the current oncology landscape and predictions for the coming year.

Advancements in Oncology

Throughout the discussion, both women highlighted recent advancements in the oncology landscape that may result in transformative differences for patients and providers. Changes in the regulatory environment, new risk assessment protocols and tools, and therapeutic discoveries are critical components that have guided the evolution of oncology.

Regulation

One component is the regulatory aspect, which includes clinical trial protocols and participant guidance. As new treatments come out and evaluations of study protocols identify strategies for improving therapeutic outcomes, regulatory bodies, including the United States Food and Drug Administration (FDA), have adjusted their guidance to reflect discoveries.

For example, Del Rio noted, “The FDA's recent update on including older adults in oncology is important. It's more inclusive and focuses on people who are likely to receive treatment.”

In 2022, the FDA issued a final guidance, “Inclusion of Older Adults in Clinical Trials,” encouraging researchers to include older adults in cancer clinical trials. Supporting President Biden’s cancer moonshot effort, these recommendations urge involvement in early clinical trials and provide recommendations for trial design, recruitment, information collection, and reporting for older populations.

Risk Assessments

Del Rio also notes that critical technological evolutions have advanced the understanding of who is more likely to have a malignancy, allowing providers and researchers to assess cancer risk more accurately.

“For instance, proteomics is super smart. It focuses on how protein expressions will reflect a physiological state. It's very accurate and precise,” she explained. “Providers can use it to target or determine an early intervention or even early treatment, which is impactful in terms of how and who gets treated for oncology stays.”

Proteomics falls under the category of multi-omics, which has been a particular area of interest in the diagnostic world, gaining more attention after the false claims made by Elizabeth Holmes and Theranos.

Multi-omics profiling — which includes proteomics, measurements focused on proteins and their expression; metabolomics, focused on metabolites; and transcriptomics, focused on transcriptomes — has been explored for diagnostics and gathering health insight data.

In fact, Stanford researchers have outlined the process of multi-omics microsampling in a 2023 Nature Biomedical Engineering article, describing how they have come closer to delivering on the empty promises from Theranos.

Targeted Therapies

Beyond proteomics, developing new target therapies that leverage the body’s immune system and other biological tools to fight cancer has marked a significant advancement in oncology.

Ozier emphasized the , including chimeric antigen receptor (CAR) T-cell therapy and mRNA therapeutics, coming down the pipeline.

Since the first FDA approval of CAR T-cell therapy in 2017 for pediatric and young adult patients with acute lymphocytic leukemia, CAR T-cell therapy has been implemented for multiple indications. Despite recent FDA investigations into the safety and risks associated with CAR-T, many medical professionals and scientists maintain that the benefits of this targeted therapy outweigh the risks.

Additionally, mRNA vaccines have been explored as a potential treatment for cancers. According to an article published in the American Journal of Medicine, mRNA vaccines can trigger cytotoxic T-cell responses, yielding similar outcomes to CAR T.

Besides cell therapy, Ozier included that gene editing and genetic manipulation technologies, like CRISPR, are bringing new treatments to market.

Screening and Diagnosis

Although these advancements have improved patient outcomes and provided additional tools in the oncology landscape, patient survival hinges on diagnostics and treatment access. Focusing on diagnostic tools and screenings, Del Rio explained, “Screening typically is a standardized process. It can be for healthy patients; it can be for anyone more at risk.”

While the screening rate changes depending on patient risk and life stages, the general premise is the same.

On the other hand, diagnostics are used when an issue is suspected, or abnormalities are detected during a screening.

“It's interesting how the same tool can be used for screening and diagnostics. Mammography is a good example.”

Prioritizing Screening and Diagnostics

While developing new technologies is critical and impactful in the oncology space, applying, leveraging, and effectively using these tools is what makes a difference in patient outcomes. Leveraging these technologies for early detection, diagnosis, and treatment is vital to making these tools valuable.

“Part of that process is the traditional approach of having people come into clinics, running the usual diagnostic tests. But part of it is understanding that true early prevention and detection involves bringing those technologies to the patient,” noted Del Rio. “People are trying to move in the direction of making it more realistic, more user-friendly, and reducing the pain point as part of making tools for real-life use.”

The shift toward more accessible and favorable screening and diagnostic tools may support earlier disease detection.

“The hope [with early detection] is that there won't be anything metastasized. The earlier [a provider] can detect something, it might be in place, as opposed to metastasizing and then getting out of control and being much worse,” Ozier told LifeSciencesIntelligence.

Despite the widespread understanding that early detection and early screenings are indicators of patient outcomes and survival, a NORC study published in 2022 determined that only 14% of cancer in the US are detected through screenings, pointing to a discrepancy between the understanding of screening importance and the application.

Part of the discrepancy can be accounted for by the limitations in screening. There are only screening tools and options available for some cancers, and those screenings may be done at varying ages or stages of life.

“Some of the screening can be viewed as invasive,” added Ozier, implying that it may deter patients from screenings.

Structural Limitations

However, other controllable factors have also contributed to this gap. For example, Del Rio notes, “The latest US census report from 2022 noted that about 8% of Americans don't have health insurance. That’s the minority, but it's a contributing factor.”

Most patients cannot afford to get screened as recommended without health insurance. Additionally, patients without insurance who are experiencing symptoms may put off seeing a physician due to financial restraints.

Beyond that, Del Rio explained, “There's an element of control by insurance companies. How early can someone get in to see an appointment, and is that provider covered under someone's insurance? And anyone who knows someone or who has experienced cancer themselves would know that it can be a very long, expensive process.”

Social Limitations

In addition to structural barriers that limit access to screenings, social factors contribute to low screening rates. For example, some patients are scared to get screened. Del Rio points out that, for some patients, knowledge can be scary, so getting to screenings may be anxiety-inducing for some patients.

Moreover, a health literacy gap may be contributing to low screening rates. Some patients may not know or understand the importance of screenings, where to access them, or what to do with that information once they have it.

Improving Access Through Data Analytics

The oncology landscape may be able to incorporate data analytics and technologies to streamline and shorten the diagnostic pathway.

“There's a lot of data sharing, especially through NIH's dbGaP, their whole project on data sharing, and wanting institutions to share data across health exchanges like electronic medical records sharing,” Ozier revealed. “The regions are pooling together their data. We're at the beginning of this sharing, but that will lead to faster diagnosis, better screening, and better treatments overall.”

Future Outlooks

Del Rio and Ozier provided LifeSciencesIntelligence with some predictions for the oncology landscape in the coming year. They emphasized improving the diagnostic pathway and continuing to build on existing technology.

“Bringing options to patients where they are, making it easier, and making it less painful, literally and figuratively [will be a priority],” said Del Rio.

Part of that means making it easier to access treatment and clinical trials. “Decentralization, bringing things to the participants or the patients, is important,” said Ozier.

Beyond access, technological advancements that provide targeted therapeutics will be prioritized.

“With all of the technology and with the proteomics, that it'll be more targeted therapy to certain groups, [depending on] who responds better to what,” Ozier said.

“There's been this exponential growth of technology advancement. That’s a huge part of being smarter about things. We're not okay with treatments that wipe out someone's entire immune system,” concluded Del Rio.