Immune Checkpoint Inhibitors Do Not Increase Mortality in Patients with Cancer and COVID-19
One question on oncologists’ minds recently is whether treatment with immune checkpoint inhibitors in patients with cancer has a negative effect on COVID-19 disease. So far, the data have not shown a deleterious effect, but the definitive answer is unknown. In fact, some experts think immune checkpoint inhibitors may have a positive effect on the virus.
“To what extent immune checkpoint inhibition affects COVID-19 infection in patients with cancer is unclear. Theoretically, inhibition could either mitigate or exacerbate COVID-19 infection. We designed a study to help us answer this question,” said lead author Aljosja Rogiers, PhD, Cameron Medical Oncology Fellow, Melanoma Institute Australia, Sydney.
No Impact on Mortality Rate
The results of a multicenter, retrospective analysis presented at the July 2020 AACR virtual meeting on COVID-19 and cancer showed that immune checkpoint inhibitor therapy did not increase the risk for mortality in patients with COVID-19 and cancer. The risk for mortality in those receiving immune checkpoint inhibitors was 8%.
“This is similar to the mortality rate in the general cancer population [with COVID-19], which is reported to be in the range of 7.6% to 12%,” said Dr Rogiers.
None of the 9 deaths that occurred during the study period was related to immune checkpoint inhibitors. All 9 patients had advanced cancer, and 7 patients died from COVID-19–related complications.
“The question of whether immune checkpoint inhibitors and other immunotherapy worsens outcomes in cancer patients with COVID-19 is being studied. Data so far suggest that they likely do not do worse than other cancer patients, and they may even do better,” said AACR President-Elect and Program Committee Chair of this meeting, David A. Tuveson, MD, PhD, FAACR, Director, Cold Spring Harbor Laboratory Cancer Center, NY. Dr Tuveson was not involved in the study presented by Dr Rogiers.
Confirmed COVID-19 Disease
The study presented by Dr Rogiers included 113 patients with cancer who received treatment at 19 centers in North America, Europe, or Australia, had laboratory-confirmed COVID-19 infection, and received immune checkpoint inhibitor therapy after testing positive for the virus.
The majority (82%) of the patients received treatment with 1 immune checkpoint inhibitor, 13% of the patients received an immune checkpoint inhibitor plus a CTLA-4 inhibitor, and 5% of the patients received a different immunotherapy. None of the patients in the study received chemotherapy.
The patients’ median age was 63 years, and 65% were male. A total of 74% of the patients had advanced cancer. The overwhelming majority (90%) of the patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1.
Overall, 60% of the patients were symptomatic for COVID-19 disease. The most common COVID-19–related symptoms were fever (68%), cough (59%), dyspnea (34%), and myalgia (15%).
Additional comorbidities included cardiovascular (27%), complications of diabetes (15%), pulmonary conditions (12%), and renal complications (5%).
In all, 29% of the patients were admitted to the hospital for COVID-19 disease and received treatment with antibiotics (25%), oxygen therapy (20%), glucocorticoids (10%), antivirals (6%), intravenous immunoglobulin (6%), and interleukin-6 (2%). In addition, 5% of the patients were admitted to the intensive care unit, where 3% received mechanical ventilation and 2% received vasopressin.
A total of 61% of the patients were discharged from the hospital; 12% remained in the hospital, and 27% (9) of those who were admitted to the hospital died by the time of data cutoff.
“Although the numbers of types of cancer in those who died were small, it appeared that COVID-19 has a slightly higher rate of mortality in patients with non–small-cell lung cancer compared with melanoma,” Dr Rogiers pointed out.
At Johns Hopkins Hospital, each specialist in my practice sees approximately 8 to 10 patients with nonmetastatic NSCLC per month, some of whom are not candidates for surgery based on physiologic parameters. In most cases, we follow the NCCN Guidelines or ASCO clinical practice guidelines in our management of patients with early-stage NSCLC, except in clinical scenarios where the patient may not fit into a particular category within the guidelines, or when we enroll a patient in a clinical trial. For example, we may determine that a neoadjuvant clinical study is appropriate for a patient with stage IB NSCLC, whereas this recommendation is not concordant with the NCCN Guidelines. There are also instances in which we apply recently published clinical study data when managing our patients—even before the NCCN Guidelines have been updated to reflect the most recent findings.
According to the FDA’s “Center for Drug Evaluation and Research (CDER) Annual Report: New Drug Therapy Approvals 2019,” the agency approved 48 novel drugs in 2019. Although this number does not approach the record of 59 approvals in 2018, it far surpasses the mere 22 approvals that occurred in 2016.