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dna, genomics

While many of us have avoided exposure to Covid-19 by sheltering in place, patients with advanced cancer have faced difficult choices about moving ahead with immune-compromising, but potentially life-saving treatments, and leaving the safety of their homes to receive infusions at hospitals or treatment centers.

Even more challenging, for many patients, the pandemic has altered the landscape of practically available treatment options. The best treatment for many patients with advanced cancer is often available only through a clinical trial. Trials traditionally have taken place at leading academic medical centers, which means patients often must travel long distances to participate and receive novel treatment.

Precision medicine has always been about getting the right drug to the right patient at the right time. I would argue not only do we in the oncology community need to embrace the promise of precision medicine more fully – but also that the definition should be expanded to, “the right drug to the right patient at the right time and in the right place.” We need to make promising treatments, including the latest clinical trials, available locally.

Advancing Precision Medicine through Tumor Molecular Profiling
Comprehensive tumor molecular profiling is foundational to precision medicine. While patients may have the same cancer type, variations within individual genomes may determine how well one patient responds to a certain treatment compared to another. Oncologists must have access to actionable molecular information to select the right treatment for their patients.

Since the human genome was mapped for the first time in 2003, a number of technological and scientific advances have made it possible for patients with cancer to receive comprehensive tumor molecular profiling results in less than two weeks, with costs increasingly covered by payers. Biomarkers are now widely used to identify patients for treatment with a specific therapeutic agent. Increasingly, cancer therapies are developed in tissue-agnostic indications, meaning they are approved based on molecular changes rather than the site of tumor. In June of this year, the U.S. Food and Drug Administration approved pembroluzumab (Keytruda) for the treatment of any solid tumor that is tumor mutational burden (TMB) high.

With these advances, one would think that every patient with advanced disease would receive tumor molecular profiling as a standard of care. However, this is not the case. Only about 15% of patients with advanced cancer receive comprehensive tumor profiling. Widespread deployment of tumor molecular profiling is emerging as a rate-limiting factor for how rapidly we can drive better outcomes for all patients with cancer.

Practical Challenges to Widespread Precision Oncology Access
Why are patients not able to fully benefit from the promise of precision medicine? There are a several key barriers to access, including:

  • Tumor tissue availability: A recent study presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO) revealed that of the 20,000+ tumor tissue samples collected in an observational trial, fewer than half met minimum tumor surface area requirements for leading commercial hybrid capture-based comprehensive profiling tests.
  • System-wide delivery: Health systems, particularly those in the community setting, face challenges implementing widespread testing, including pathology best practices, operational workflow, and incorporation of results into clinical decision-making.
  • Access to clinical trials: In normal times, geographical considerations represent an important barrier to study access. The sentiment to make clinical trials available locally becomes even more pressing during these times. A recent JAMA Network Open study showed that the Covid-19 pandemic is associated with a notable decrease in enrollment in National Cancer Institute-sponsored clinical trials. As states continue to open, with no treatment or vaccine in sight for the foreseeable future, it is likely that patients will remain cautious, perhaps feeling even greater risk as society moves more freely.

Addressing the Challenge
How precision medicine companies, providers and health systems work together to develop and deploy solutions will determine how successfully we can deliver on the promise of precision cancer care. Some precision medicine companies are developing blood tests, called liquid biopsies, that identify potential tumor cells circulating in the blood with the goal of reducing reliance on tumor tissue biopsies. Others are undertaking educational campaigns to encourage broader uptake of comprehensive genomic testing. And there are companies that deliver a comprehensive precision oncology program to health systems, providing widespread and routine access to comprehensive tumor molecular profiling paired with local access to a portfolio of biomarker-guided clinical trials. A study presented by Kaiser Permanente Northern California at the 2020 ASCO meeting demonstrated how industry partnerships can enable health systems to implement and deliver a large-scale comprehensive precision oncology program.

Knowing which treatment is right can mitigate risk in unexpected ways as well. In a recent anecdote from our lab, tumor tissue from a 70-year old patient with advanced non-small-cell lung cancer was sequenced and found to have a rare, but highly actionable, gene fusion that could be treated with an orally available targeted therapy. Instead of having to attend multiple infusion visits for chemotherapy and immunotherapy that would result in substantial exposure risk to Covid-19, the patient can now receive a targeted therapy that can be taken at home with an expected dramatic response.

A Better Future
This pandemic has taken a toll on everyone, and patients with advanced cancer have faced unique challenges. However, the opportunity before us is one to create the future we should all be working toward: a future where the right patient receives the right treatment, at the right time and in the right place. As we continue to work our way through this current pandemic, let’s envision a future where every patient with cancer has access to the latest in precision medicine by implementing broad-scale genomic testing and democratizing access to clinical trials so that whatever environment we face, cancer patients will always receive the best care.

 

 

 

 

 

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