Cancer trials smashed by COVID-19
COVID-19 appears to have led to a 60% decrease in oncology trial launches between 2019 and the onset of the pandemic in 2020.
The study aggregated all phase 1 to 4 oncology trials of drugs or biological agents hosted on the RAVE clinical trial platform that opened for patient accrual during the eight consecutive months of October through May over five successive years (2016-2020).
It found the number of trials increased over time in the first four pre-pandemic years (229, 304, 340 and 376 respectively), then dropped to 191 trials in the pandemic period.
The researchers said the COVID-19 pandemic may be associated with long term indirect effects on population morbidity and mortality through pathways such as arrested drug development.
“This large pandemic-associated decrease in trial launches raises concern regarding its potential negative impact on the development of new cancer therapies, and to the extent that these findings are generalisable to other conditions, the momentum of scientific progress for other disease areas as well.”
Read more in JAMA Network Open
Little evidence on QOL with cancer drugs
A systematic review of trials cited as evidence for regulatory approval of systemic oncology therapies has found very few include data on quality of life (QOL) despite many being used in a non-curative setting.
Published QOL evidence was available in only 14% of 214 FDA-approved indications and 26% of 170 EMA-approved indications at the time of regulatory approval. That proportion rose to 40% of FDA-approved indications and 58% of EMA-approved indications over time.
At the time of regulatory approval, few FDA- and EMA-approved indications demonstrated clinically meaningful improvements in QOL beyond MCID (3% and 6% respectively).
The study said there was a disconnect between what is meaningful and important to patients and what is being favorably approved by regulatory boards.
“These findings are especially concerning for patients with advanced disease. As the goals of care may evolve throughout the course of disease, QOL may become of greater importance for those treated with palliative intent.
Read more in JAMA Network Open.
Immune checkpoint inhibition no extra burden in COVID-19
Patients with cancer are at a higher risk of severe COVID-19 infection than people without comorbidities but treatment with ICI does not appear to be an additional risk factor overall.
A retrospective, cohort study of 110 cancer patients with confirmed COVID-19 infection treated with ICI across nine countries including Italy, the UK, US and Australia, found COVID-19–related mortality in these patients does not appear to be higher than previously published mortality rates for patients with cancer.
About a third of patients in the study required hospital admission and 6% required ICU admission. Inpatient mortality of these patients with cancer treated with ICI was high in comparison with previously reported rates for hospitalised patients with cancer.
About half of deaths were due to COVID-19. But many factors other than ICI treatment were associated with an increased risk of death including residence in North America versus Europe (HR 6.30, p=0.0006), pre-existing kidney disease (HR 4.09, p=0.0271), ECOG ≥2 (HR 3.84, p=0.0115), dyspnea (HR 3.49, p=0.0182), lymphocyte count <1500/mm3 (HR 4.38, p=0.0250) and CRP ≥100 mg/mL (HR 3.70, p=0.0194).
The study said a better understanding of high-risk inflammatory phenotypes prone to develop severe COVID-19 illness remains essential, particularly in an ICI context.
Read more in the Journal for Immunotherapy of Cancer.