Oncology is a multi-faceted field of study and a popular one. Cancer clinical trials account for more than 19% of the research studies in progress – but popularity is not a sure predictor of success. Oncology as a therapeutic area has experienced some ups and downs over the past year. In this article, we will summarize some of the critical events of 2020 and early 2021.
Impact of COVID-19 on Cancer Trials
The fact that COVID would affect oncology trials is expected, but the extent of that impact is perhaps more involved and far-reaching than many estimates. From 23 March to 3 April 2020, roughly 80% of active oncology trials in the US and 86% of those in Europe were unable to enroll participants at their usual rates. The availability of patient care in inpatient and outpatient settings was a factor, as was the route of administration and concerns over study subject safety. In eight out of 10 cases, protocol deviations emerged–many of which caused incomplete patient data.
Technology-based interventions (e.g., telemedicine, remote monitoring) helped bridge the gap, but the impact was still significant. Study milestones were being postponed, and that sets back everything else. These delays have a tangible impact on the field of oncology as a whole. There was a 60% decrease in oncology trial launches during the first wave of the pandemic. With that level of impact, COVID-19 has an indirect effect on public health in the form of arrested drug development.
Surgical Treatment of Cancer
The past year wasn’t all bad news in the world of oncology. ASCO found that the 2020 Advance of the Year was the “Refinement of Surgical Treatment of Cancer.” The organization explained its finding:
Surgery has played a fundamental role in cancer treatment. It was the only treatment available for many cancers until the advent of radiation and chemotherapy. The explosion in systemic therapies since then has resulted in significant changes to when and how surgery is performed to treat cancer.
Some cancers, such as pancreatic cancer, have increased the number of patients who can benefit from surgical intervention. At the same time, other treatments are less invasive, such as those for renal cell carcinoma or advanced melanoma. Much of this progress came as the result of federal funding encouraging and financially supporting oncology research.
These efforts and those like them have lowered cancer death rates by 27% (since 1991) and increased life expectancy after diagnosis. Some of these gains may continue. In the United States, Congress approved an additional $2.6 billion in funding for the NIH in fiscal 2020.
Biomarker and Targeted Applications
Precision medicine is evolving as technology improves. In May 2020, the FDA approved a drug for lung and thyroid cancers. It is called selpercatinib (brand name: Retevmo), and it works on cancers caused by a specific gene mutation called “RET fusion.” A study in the New England Journal of Medicine came out a few months after the FDA approval of selpercatinib. It found that the response rate is 85% for people who have never received any treatment for their cancers and 64% who had received previous treatments had their tumors substantially shrink after taking the drug.
Like RET, a cancer gene called KRAS is responsible for as much as 25% of lung cancers and up to 50% of colon and rectal cancers. In 2020, a drug that directly targets KRAS was developed called sotorasib. It isn’t a cure per se, but so far, the trial evidence looks like the drug can slow or stop cancer growth in people with certain mutant KRAS proteins.
Combination Therapies Combination cancer therapies also improved in 2020. In April 2020, the FDA approved the use of two drugs – encorafenib and cetuximab – to treat people who have tumors with a BRAF mutation, making them effective for as many as 10% of people with colorectal cancer. Some other advances include:
- The impact of HPV vaccines against cervical cancer
- Personalized treatment based on individual biomarkers
- Combination therapies that limit toxicity
- Targeted treatments for the worst cancers
New Hopes for Advanced Cancers
With the restrictions of COVID and the advancement of personalized medicine, cancer trials are being reimagined. In some cases, researchers are going to study subjects instead of having them come to sites, while in other cases, these new approaches involve telemedicine. While there remain many unknowns in a post-pandemic world, choosing a CRO that is large enough to deliver and small enough to be agile is critical for oncology study success.
If you have an upcoming cancer trial, contact Pharm-Olam for a proposal. We can help you explore your options and explain some of the approaches that we are using to prepare for the worst with regard to the COVID-19 pandemic and create contingency plans that keep studies active.
- Lamont, E.B., Diamond, S.S. & Katriel, R.G. (2021). Trends in Oncology Clinical Trials Launched Before and During the COVID-19 Pandemic. JAMA Network, Research Letter, 27 January 2021. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2775637
- Markham, M.J., Watcher, K., Agarwal, N., Bertagnolli, M.M., Chang, S.M. & Dale, W (2020). Clinical Cancer Advances 2020: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology. Journal of Clinical Oncology, 38 (10). https://ascopubs.org/doi/10.1200/JCO.19.03141
- Memorial Sloan Kettering Cancer Center: Year in Review: Five Important Clinical Advances in Cancer in 2020
- National Cancer Institute: Responding to Coronavirus, Cancer Researchers Reimagine Clinical Trials
- National Cancer Institute: Treatment Research
- Upadhaya, S., Yu, J.X., Oliva, C., Hooton, M., Hodge, J. & Hubbard-Lucey, V.M. (2020). Impact of COVID-19 on oncology clinical trials. Nature, Biobusiness Briefs, 18 May 2020. https://www.nature.com/articles/d41573-020-00093-1