The promise of precision medicine—tailoring treatments to genetic changes in each cancer patient—is very exciting. Advances in science and genomic testing have helped speed up the pace of precision medicine and brought several innovative targeted therapies and immunotherapies to market already. Precision medicine was the theme at last year’s American Society of Clinical Oncology (ASCO) annual meeting, with more than 500 abstracts involving genomic testing. It’s safe to say that precision medicine has become a buzzy topic. However, at this year’s ASCO event, we continued to hear that there are significant challenges to the widespread adoption of precision medicine. What will it take to bring the promise of precision medicine to more patients and embed it in routine care?
At ASCO, my colleague, Jon Roffman, had the opportunity to speak with Dr. Julie Vose, the head of hematology and oncology at the University of Nebraska Medical Center and former ASCO president, about precision medicine. Here are a few key topics that they discussed:
- Clinical actionability limitations of certain tumors: While there’s a lot of hype around the concept of precision oncology, physician decision-making is still largely driven by actionability: What action can they take to improve patient outcomes based on the unique molecular profile of that patient’s tumor? Tumor types such as non-small-cell lung cancer (NSCLC) have a range of actionable driver mutations including EGFR, ALK, ROS1, BRAF and MET, and associated targeted treatment options with proven clinical benefit. However, other tumor types have few, if any, actionable driver mutations based upon current therapy options. As Dr. Vose mentioned, for genomic testing to become mainstream and reflexive at diagnosis across all tumors, practicing oncologists are looking for clinical validation and a risk-benefit assessment of genomic testing in other tumor types.
- Testing up front vs. later: For many physicians, it still remains an open question whether patients should undergo genomic profiling at metastatic diagnosis or after exhausting proven options. Dr. Vose noted that in her clinical practice, genomic testing up front at diagnosis is limited to tumor types such as lung cancer and breast cancer where targeted therapies have proven to show clinical benefit. For other tumor types, genomic testing is conducted for patients who have exhausted the standard of care and have limited treatment options in later lines of therapy.
- Paying for precision medicine: Despite CMS coverage of broad molecular profiling tests such as F1CDx and Guardant360, oncologists continue to face challenges with approval from insurance companies for genomic testing and are worried about the financial burden on patients. As Dr. Vose said, “A lot of times, we can’t get approval from insurance companies to get the testing done, and patients are slapped with a huge bill.”
Accelerating Precision Medicine
The combination of investment from providers, business model innovation from pharma and diagnostic companies, and patient empowerment will accelerate precision medicine to become mainstream. Here’s what’s needed:
1. The development of more efficacious targeted therapies that increase the actionability of precision medicine: With more than 100 ongoing phase II and III trials for targeted therapies, the continued investment from the biopharma industry to bring efficacious targeted therapies to market will accelerate the adoption of precision medicine. Moreover, tissue-agnostic targeted therapies such as larotrectinib have marked a new paradigm in precision medicine with strong efficacy (around 75% overall response rate) across all tumors. The introduction of more tissue-agnostic targeted therapies will accelerate the use of broad genomic profiling across all tumors.
2. More evidence to support a precision-based approach: Many physicians believe that just because patients with a certain mutation in a tumor type are benefiting from precision medicine doesn’t mean that all patients with this mutation in all tumors will also benefit. As a result, there’s a need to generate more evidence to support precision-based approaches to treatment, which requires more investment from providers in data management and infrastructure.
3. Disruptive business models: Companies such as Tempus are introducing disruptive business models by offering free sequencing in exchange for data. Tempus has already established partnerships with several health systems and ASCO, advancing the reach of precision medicine to cancer patients. While other diagnostic companies that offer genomic testing are getting embedded within health systems by providing billing support, a tumor board and data partnerships to support their precision medicine programs, we’ll continue to see business model innovation from both pharma and diagnostic companies to unlock the value and increase the reach of precision medicine to all cancer patients.
4. Patient empowerment: In this digital era, patients have access to a wealth of information about precision medicine and genomic testing. With each passing day, more patients are educated about precision medicine and are proactively requesting genomic testing. Even ASCO’s theme from this year’s event—“caring for every patient, learning from every patient”—suggests that the role of patients in cancer care decision-making will continue to increase. With more patients playing an active role, it will only be a matter of time before payers will start to reimburse for broad molecular profiling across all cancer patients.
While there are still barriers to adopting target treatment approaches, increasingly we are approaching a world where every cancer patient can benefit from precision medicine.