Over the past several months, we spoke to experts across the precision medicine landscape to understand some of the key changes and most impactful scenarios they expect in this space. We shared the following ‘subway map’ to help pinpoint exactly where these changes would occur and determine which stakeholders would both drive and be impacted by the evolving landscape. These findings were recently shared at the Companion Diagnostics Forum, and the following is a deeper dive into some of our top findings.

Figure 1 – Map of the precision medicine landscape used to guide stakeholder discussions around unmet needs and expected changesWe spoke with stakeholders familiar with each of the 4 ‘verticals’ of this map (Dx Development, Tx Development, Clinical / Patient Perspective, RWD / Health AI); the following includes several of the key changes and scenarios we may see in the Tx development space over the next 5-10 years as outlined by these experts.

Therapeutics Improvements

Broadly speaking, precision oncology experts expect to see both incremental improvements and seismic shifts in treatments applied to both early and late stage cancers. Targeted treatments (i.e. surgery, radiation) will see technological improvements and continually be augmented by testing to ensure it is the best therapeutic course for a given patient, but we will also see entirely new classes of treatments enter the clinic (i.e. allogeneic cell therapies, personalized cancer vaccines).Among the diverse advancements we’ll see in the therapeutics space, two subtopics were repeatedly identified by experts as key changes we may see mid-long term. These include:

1. An increasing number of tumor-agnostic drugs and indications are expected to be approved; cancers could become classified by biomarker profile rather than site of origin
2. Improved efficacy and survivorship will create a snowballing effect to boost patient advocacy, education/awareness of options, and promote development of curative rather than palliative therapies

Scenario Subtopic 1 – Expansion of Therapy Agnostic Drugs & Indications

Figure 2 – Potential evolutionary staging of events and key stakeholder impacts assuming the development and adoption of tumor-agnostic drugsKey Stakeholder Impacts

• Physicians – Not only will the growing menu of approved therapies create burden for physician continuing education, but biomarker driven classifications of new therapies could greatly increase the factors physicians have to weigh when even making an initial diagnosis (i.e. which biomarkers to test, which tests to order)
• As these pan-tumor approvals become more ubiquitous, patients & physicians in community settings stand to see some of the most positive impacts; while off-label compassionate use and trial enrollment are common practice in AMCs, patients in community settings are less likely to be given an off-label drug even if a targetable mutation is detected, a gap which could narrow following biomarker-centric approvals
• With increasing emphasis on biomarker driven patient stratification, pathologists could potentially assume increasingly important roles as advisors on molecular tumor boards and educators to oncologists to help navigate patient treatment options and companion diagnostic selection
• Diagnostic Developers – As biomarkers will increasingly be used to guide multiple lines of therapy, large panel tests (i.e. comprehensive genomic profiling or WES) may see increased use, leading to reduced retesting but at an overall greater diagnostic expense per patient
• Pharmaceutical / Therapeutic Developers – Following initial validation of therapies that are pharmacologically active across tumor types, we could see initiation of more basket trials that enroll patients based solely on markers
• Health AI / RWD Aggregators - Recognizing clinically actionable biomarkers from the broader patient population via RWD and retrospective analysis could be a key step to speeding R&D timelines and moderating future therapy development costs

Scenario Subtopic 2 – Improved Therapy Efficacy and Survivorship

Figure 3 – Potential evolutionary staging of events and key stakeholder impacts assuming Tx improvements lead to improved overall efficacy and survivorshipKey Stakeholder Impacts

• Patients – As new therapies continuously lead to improved survival, success stories will help drive patient advocacy groups, promoting enhanced education of therapeutic options and potentially drive more proactive requests for cutting edge therapies. These requests will have to be carefully navigated by physicians to ensure eligibility and coverage With increased survivorship comes the need for longer-term maintenance therapy and recurrence monitoring; as cancer treatment is increasingly treated as a lifelong, recurrent (but manageable) disease, the overall cost of addressing the disease could increase as follow-up spans many years
• Insurers / Payors – Following the establishment of new survival benchmarks (especially in late-stage disease), payors will wish to refocus pricing/payment discussions around managing long-term vs acute care; notably, pricing for months rather than years of survival may not be favorably seen, and added value will be placed on factors like durability of response and mitigating side effects
• Physicians – Enhanced treatment efficacy will position primary care physicians (PCPs) to increasingly assume oversight of the ongoing maintenance therapy and monitoring of patients who have undergone curative treatment; the education burden may fall on PCPs to understand which therapeutic and diagnostic tools will adequately keep patients cancer-free while enhancing quality of life and long-term affordability
• Pharmaceutical / Therapeutic Developers – Maintenance therapies and treatments for cancer recurrence could see greater investment; value-based-care will be increasingly prioritized, and factors beyond incremental survivorship (i.e. quality of life, at home Tx options, fewer side effects), may become key differentiating factors biopharma works to optimize

Key Considerations for Precision Medicine Developers

From the above scenarios outlining the expansion of pan-cancer therapy options and the enhancement of therapy efficacy/survivorship, there are several key takeaways with implications for all players in the precision medicine space:

1. Managing Physician Education Burden – A broader menu of treatments supported by numerous biomarkers will require multi-disciplinary and collaborative care-teams; education resources should be optimized to guide multiple treatment lines at patient diagnosis and streamline care
2. Care Decentralization – Broader treatment options will allow patients with complex cancers to be treated in community rather than AMC settings; follow-up care may be managed in primary care settings, decreasing patient tolerance to travel long distance for treatment
3. Pricing for Long-Term vs Acute Cancer Care – Treatment may become episodic vs acute; adverse events less acceptable, and value-based care will be key

Enjoy this report? Check out our previous posts outlining key painpoints / unmet needs in the precision oncology landscape today and part 1 on potential evolutionary changes around Diagnostics Developments. You can also access the full presentation here