The last month at a glance:?
- Healthcare access: A JAMA study finds that individuals in disadvantaged census tracts are 53% more likely to die from breast cancer than those in advantaged census tracts, even after adjusting for insurance coverage, socioeconomic status, comorbidities, and adherence to NCCN guidelines.?
- Cancer research: Phase III clinical trials for the first personalized mRNA vaccine for treating melanoma are underway. mRNA vaccine trials are also ongoing for treating other advanced, hard to treat cancers such as pancreatic, head and neck, liver, and brain. There is more optimism today about the potential efficacy of the technology. However, should any of these vaccines get FDA approval, we expect costs to be high given the personalized nature of the treatment, which will likely limit coverage and utilization.?
- Policy and coverage: As part of the inaugural National Cancer Prevention and Early Detection Month, the White House Cancer Moonshot released two Fact Sheets, highlighting commitments from 1) the Federal government and 2) major employers and industry leaders to improve access to cancer screening and prevention services for American workers.?
- Policy and coverage: According to the U.S. Preventive Services Task Force (USPSTF), and as covered by Reuters last month, women aged 40 and above should begin screening for breast cancer via mammogram every other year. Previously, USPSTF guidelines and some insurance coverage for breast cancer screening began at age 50, despite a significant increase in breast cancer incidence under age 50 over the past decade.?
- Takeaways from AACR liquid biopsy readouts: At this year's American Association of Cancer Research (AACR) conference, many liquid biopsy and early cancer detection companies showed promising new results on efficacy and new applications. However, researchers at the World Health Organization (WHO) presented concerns that detecting cancer early, the main proof point that multi-cancer early detection companies such as Grail are using to demonstrate efficacy, may not be enough to prove clinical utility.
Key news and research deep dive
Population health: Individuals in disadvantaged census tracts are 53% more likely to die from breast cancer.?
- A study in JAMA this month reviewed a group of 5027 breast cancer patients across five census tracts to determine whether or not neighborhood disadvantage would impact breast cancer-specific survival.?
- After controlling for individual risk, including insurance coverage, sociodemographic factors, comorbidities, and adherence to NCCN guidelines, the study found that individuals in disadvantaged census tracts were still 53% more likely to die, and more likely to die sooner, from breast cancer, compared to individuals in advantaged census tracts.?
Impact: This is clear quantification of the significantly worse outcomes that result from barriers to screening and care. The study also shows that coverage alone is not enough to improve cancer outcomes. Challenges such as care availability, inadequate access, lack of appropriate support, and other unknown barriers are creating a large discrepancy in outcomes despite insurance coverage. For individuals living in disadvantaged geographies, strategies such as more convenient screening options, telehealth access to cancer experts, and targeted support services can complement their health plan to close this gap in access.??
Recent research: Early trials show promising future for? personalized mRNA vaccines for hard to treat cancers, but cost and coverage will be a challenge.
- An article in BBC covered the beginning of a Phase III trial in the UK of the first personalized mRNA vaccine to treat melanoma. The vaccine—“the jab”, mRNA-4157 (V940)—uses the same technology as the COVID-19 vaccine and is designed to match each patient’s and tumor’s unique genetic signature. In doing so, the vaccine stimulates the patient's own immune system to attack and destroy melanoma cancer cells.?
- The 60 to 70 patients who participate in the trial must have had high-risk melanoma surgically removed within the past 12 weeks. Half will receive the placebo, and half will receive the vaccine.?
- In Phase II trials, results showed that trial participants who received the jab were half as likely to die from melanoma or see their cancer return in the next three years.??
- At the American Association for Cancer Research (AACR) annual conference this year, there were also promising readouts on early stage trials for vaccines to treat pancreatic, head and neck, liver, lung, and brain cancer
Impact: Early stage trials of mRNA-based cancer vaccines have been showing encouraging results and generating much needed optimism in their ability to provide better therapeutic options and outcomes for patients with hard to treat cancers today. However, the technology relies on personalized treatment development to match the vaccine to the patient and their specific cancer antigens, which will come at a high cost. We expect any approved treatment to create challenges in coverage and cost management for plans in the future.??
Policy: The White House releases two Fact Sheets announcing commitments from 1) the Federal government and 2) leading employers and industry partners to make cancer screening more accessible for employees.?
- In April, the White House released two new Fact Sheets containing commitments from the Federal Government and from Hasbro, Amazon, United Airlines, Lyft, and other employers and industry leaders to remove barriers of access to cancer screening for American workers.?
- Commitments (including one from Color and the American Cancer Society) range from widespread education efforts on prevention and early detection, free breast and skin cancer screenings, more accessible screenings for miners and other workers exposed to lung carcinogens, and partnerships with the American Cancer Society to increase HPV vaccination rates.?
- For example, Hasbro, a Color partner, is working to provide a comprehensive suite of benefits to their employees, including accessible cancer screening, results management, and care navigation services.?
Impact: With cancer incidence rising, employers are recognizing the need to increase cancer screening rates and early cancer detection in their population. The commitments in the Fact Sheet suggest that employers are starting to take a more proactive approach to solve their cancer problem, going outside their traditional plan coverage to offer more convenient screening options for their employees through telehealth, on site, or at home screening programs.
Policy: New U.S. Preventive Services Task Force (USPSTF) guidelines recommend women begin mammograms now at age 40.?
- Last month, USPSTF breast cancer screening guidelines changed, dropping the age recommended for women at average risk to start breast cancer screening via a mammogram from age 50 to age 40. USPSTF recommends mammograms every other year unless otherwise instructed by a provider.?
- These updates bring the USPSTF guidelines in alignment with screening recommendations from other organizations such as the American Cancer Society (ACS), the American College of Obstetricians and Gynecologists, and the National Comprehensive Cancer Network.
- With this change, insurance coverage of preventive breast cancer screening will start at age 40, as required by law.
Impact: While this represents a step by the USPSTF to recognize the rising incidence of breast cancer in individuals under age 50, these updated guidelines will likely take a longer time to see consistent and comprehensive uptake among providers. Last fall, the ACS found that 72.3% of adults who were out of compliance with colorectal cancer screening did not receive a recommendation to get screened from their doctor, two years after the USPSTF’s changes to colon cancer screening guidelines. This goes to show that despite best intentions, employers can expect a lag in adoption of these guidelines amongst PCPs, amidst a growing need for breast cancer screenings among eligible populations.???
Takeaways from the American Association of Cancer Research (AACR) 2024 Conference: Liquid biopsy companies show promising results on efficacy and applications, but claims of clinical utility are still hard to make.
Key takeaways:
- City of Hope shared results of their exome-based liquid biopsy test for detecting pancreatic cancer. When combined with the pancreatic cancer marker CA19-9, the liquid biopsy test accurately detected 97% of Stage I-II pancreatic cancers. City of Hope researchers believe the test should not be costly to commercialize. Pancreatic cancer detected early when still contained to the pancreas has a 44% survival rate after 5 years, compared to 3% only for advanced stages.
- Johns Hopkins researchers and Delfi diagnostics shared findings from their liquid biopsy assay for early detection of ovarian cancer. The assay identified 69%, 76%, 85%, and 100% of ovarian cancer cases staged I-IV, respectively.
- The World Health Organization conducted a systematic review published in JAMA that is challenging the use of incidence of late-stage cancer as the end point of liquid biopsy trials instead of cancer-specific mortality. Based on an analysis of 41 randomized clinical screening trials, correlation between reductions in late-stage cancer and cancer-specific mortality varied meaningfully by cancer type. For example, incidence of late-stage cancer was found to be a suitable alternative end point to cancer-specific mortality for some cancer types (ovarian and lung) but less suitable for others (breast, colorectal, prostate).?
Impact: Blood-based testing for cancer screening continues to be a hot scientific and clinical topic. Single cancer-specific liquid biopsy tests are starting to show encouraging performance, especially for cancers without any high-performing screening today, such as ovarian cancer or pancreatic cancer. The review from the WHO will continue to push the bar on demonstrating clinical utility of such tests when incidence of late-stage cancer may not be the right end-point. This will be particularly important for multi-cancer detection tests, where reduction in late-stage cancer diagnoses as a measure of screening effectiveness across all cancer types may overestimate the benefit of the test. This concern is not new, but there is now additional data to support it.?
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