In this series, Health Evolution is examining the year 2021 in health care through the lens of our eight imperatives. We will be examining the trends that were at the top of CEOs’ minds throughout the past year and what may come in 2022. This week: Realizing medical breakthroughs
For cancer patients, COVID-19 has been brutal.
A recent study from Dana Farber Cancer Institute found that even fully vaccinated cancer patients with breakthrough COVID-19 infections had a hospitalization rate of 65 percent, an ICU or mechanical ventilation rate of 19 percent, and a 13 percent death rate. Comparatively, recent data from New York State shows that only .15 percent of all fully vaccinated people were hospitalized.
“Patients with cancer who develop breakthrough COVID-19 even following full vaccination can still experience severe outcomes, including death. That is why a multilayered approach that includes masking and social-distancing, along with vaccination plus booster against COVID-19 remains an essential approach for the foreseeable future,” stated Toni Choueiri, MD, director of the Lank Center for Genitourinary Care at Dana-Farber Cancer Institute.
Another research effort, from the National Cancer Institute, found that patients with cancer are at increased risk of severe COVID-19 disease. NCI also found that hospitalized cancer patients have a severe disease course and a high mortality rate.
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But amid the harsh reality that COVID has brought to cancer patients, there is hope coming within the oncology world. The quick development of messenger RNA (mRNA) vaccines used against COVID-19 has given renewed emphasis on using the technology to increase the speed of approval for cancer treatments.
In a recent survey by research firm PureSpectrum and real-world data and analytics company COTA, 71 percent of oncologists say patient expectations for faster development of new cancer treatments have increased because of the perceived speed of COVID-19 vaccine development. While 64 percent of oncologists are satisfied with the pace of typical cancer treatment clinical trials, they understand that there is an opportunity to improve the process through the use of real-world data.
“Everyone understands that we can be more efficient with clinical trials. The pandemic highlighted the vital benefit that real-world data has when it comes to ensuring efficacy and safety for development of therapeutics,” says Andrew Pecora, MD, founder of COTA and former president of Cancer Services at the John Theurer Cancer Center at Hackensack University Medical Center. The Centers for Disease Control and Prevention (CDC), among other entities, published data that signified the benefits of the mRNA COVID-19 vaccines using real-world data, rather than traditional clinical trial data.
“With real-world evidence, we’ve shown that you don’t need a control group. If you don’t need a control group, you can use people in the real world, trial times will be cut in half, the time to complete trials will be cut in half, the cost will be cut in half and most importantly, people in the control group are not going into a study that has no potential of benefitting them more than the standard of care,” Pecora adds.
The future of mRNA vaccines and cancer
While most people likely have not heard of mRNA vaccines before the COVID-19 pandemic, they are not new. The history of the technology dates back to the 1960s. The first mRNA flu vaccine was tested in the 1990s and there was an mRNA rabies vaccine tested in 2013. Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, says mRNA cancer vaccines have been in clinical development for five years at her organization.
“COVID has shined the spotlight on mRNA vaccines and cancer. There are a number of different immune therapies ongoing and clinical trials trying to make progress for patients with both localized cancer…and for patients in the metastatic setting. Although mRNA technology was already in development with cancer, it’s given a nice spotlight to the ongoing work and brought more interest from patients who want to participate in those studies,” says McKean.
BioNTech, which produced one of the COVID-19 vaccines alongside Pfizer, is currently in the trial stage for a mRNA vaccine that can treat patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma. The company also has another trial for a potential vaccine that would treat stage II/III colorectal cancer patients. The revenue it receives from the COVID-19 vaccines will help further the cancer vaccines within its mRNA platform, according to BioNTech CEO Uğur Şahin.