publication date: May. 15, 2020
Heartland NCORP sites implement drive-through laboratory service
Two component institutions of Heartland Cancer Research NCORP have created drive-through laboratory services for outpatients during the COVID-19 crisis.
The service does not test patients for coronavirus infection, but provides a mechanism for patients with cancer and blood diseases to have laboratory studies for treatment or clinical trial requirements in the safest possible manner. The drive-up laboratory sites meet the requirements of the state and local governments’ shelter-in-place orders.
At both Springfield Clinic (Springfield, IL; Preet P. Singh, Sub-PI for Disparities and Cancer Care Delivery Research) and Missouri Baptist Medical Center (St. Louis, MO; Bryan A Faller, principal investigator), upon arrival, the patient drives into a designated parking area, calls the registration area and registers for the visit by telephone.
A phlebotomist is sent to the patient’s vehicle and performs the blood draw with the patient’s arm extended through the window. After the drive-through visit, the patient obtains results and further instructions by telephone or via the patient portal.
Springfield Clinic has developed an educational video for patients, describing the service. The service has been popular at both NCORP sites and may be a model for patient-centered service after the pandemic subsides.
Roswell Park to assess immunotherapy combination in cancer patients with COVID-19
An immunotherapy combination, rintatolimod and interferon alfa, first evaluated at Roswell Park Comprehensive Cancer Center as an approach for treating some solid tumor cancers will soon be available to cancer patients with COVID-19 through a clinical trial at Roswell Park.
FDA has authorized clinical researchers at the center to conduct a study assessing the safety and effectiveness of giving both rintatolimod and interferon alfa to cancer patients with COVID-19. The study is one of very few worldwide to repurpose an experimental cancer therapy as treatment for COVID-19.
“It’s a rare example of a concept for COVID-19 therapy that emerged from academic researchers rather than a pharmaceutical company, and it was a Roswell Park team that looked at the way these two drugs work and saw a possibility for them to enhance each other’s effects—first against cancer and now as a possible treatment for COVID-19,” Roswell Park President and CEO Candace S. Johnson said in a statement.
Pawel Kalinski, vice chair for translational research at Roswell Park, was the first researcher to propose giving these two immune-modulating drugs in combination as treatment for cancer, and is scientific lead on five clinical studies in progress or in development assessing the combination in patients with solid-tumor cancers including breast and colorectal cancer. He and clinical principal investigator Brahm Segal, will lead the team investigating whether the two drugs may function effectively together as antiviral agents that could benefit patients with COVID-19.
“There are similarities between cancer and COVID-19, which both manage to avoid activating the interferon pathway,” scientific lead on the study Kalinski, who is also director of Cancer Vaccine and Dendritic Cell Therapies, Rustum Family Professor for Molecular Therapeutics and Translational Research and Professor of Oncology at Roswell Park, said in a statement. “This helps them to go undetected and spread in patients’ bodies, and differentiates them from viruses that cause the common cold, which cause rapid symptoms and are rapidly cleared by the immune system.”
“We believe that the two agents to be tested in our trial, given together, can activate the missing interferon response in COVID-19-infected cells,” he said. “This would induce protective interferons and other antiviral factors in adjacent cells, stopping the virus from spreading in patients’ bodies and generating a synergistic effect that could help cancer patients with mild or moderate COVID-19 to fight the virus before it causes serious damage to the lungs or other organs.”
“SARS coronaviruses such as SARS-CoV-2, the virus that causes COVID-19, take hold because they’re able to evade the innate immune system,” Segal, chair of Internal Medicine and chief of Infectious Diseases at Roswell Park and professor at Roswell Park and the University at Buffalo, said in a statement. “The premise for the trial is that by activating the interferon pathway with these two agents, we may be able to deprive the virus of the ability to replicate, knocking it out before it has a chance to cause severe lung damage or other serious effects. Promising results would pave the way to a larger clinical trial that would include non-cancer patients at high risk for COVID-19 complications.”
Patients with cancer and COVID-19 have a risk of severe illness up to five times higher than people without cancer, underscoring the importance of work to develop new treatment options.
Interferon alfa-2b is an FDA-approved drug that has been used in the treatment of some cancers and can boost antiviral immunity. Rintatolimod (brand name Ampligen, manufactured by AIM ImmunoTech Inc.), a form of double-stranded RNA that mimics viral RNA, is an investigational agent that can be recognized by our immune system and activates antiviral defense pathways.
The study will test the safety of this combination regimen in patients with cancer and mild to moderate COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. Earlier published research from Kalinski’s lab has demonstrated that the combination of rintatolimod and interferon alfa-2b shows synergistic activity in preclinical cancer treatment models.
The phase I/IIb study will enroll approximately 40 patients in two stages. Phase I will see 12-24 patients receiving both rintatolimod and interferon alfa-2b at escalating doses. Once that initial phase is complete, further study participants will be randomized to two arms, or groups: one receiving the two-drug combination and a control group who will not receive rintatolimod or interferon alfa but will receive best available care.
AIM ImmunoTech has agreed to provide rintatolimod at no charge for this study.
MSK Kids study: Children with cancer are not at a higher risk for COVID-19 infection or morbidity
Researchers from MSK Kids at Memorial Sloan Kettering Cancer Center found that children with cancer are not at a higher risk of being affected by COVID-19.
This new research led by Andrew Kung, chair of MSK Kids and his colleagues, was published May 13 in JAMA Oncology.
Pediatric cancer patients are no more vulnerable than other children to COVID-19 infection or morbidity resulting from COVID-19. Of all children with cancer infected with COVID-19, 95% had mild symptoms and did not require hospitalization. MSK Kids clinicians also tested asymptomatic children with cancer finding only a 2.5% rate of positivity compared to nearly 15% in their adult caregivers.
Only half of the children with COVID-19 positive caregivers were themselves also COVID-19 positive. The researchers also found a very significance sex skewing with the vast majority of COVID-19 infections occurring in males. Together, these results suggest that children with cancer are not more susceptible than other children to infection or symptoms resulting from COVID-19, and that children are not an unrecognized reservoir of asymptomatic COVID-19 infection.
From March 10 through April 12, MSK Kids researchers instituted a screening and testing plan to mitigate risk associated with infection with COVID-19. MSK Kids patients were screened for exposure to contacts with known COVID-19 infection or for the presence of symptoms of COVID-19 illness at MSK.
Researchers performed COVID-19 testing on pediatric patients and their adult caregivers. Of the 178 unique pediatric cancer patients tested, the rate of positivity for COVID-19 was 29.3% in children with symptoms, but only 2.5% in asymptomatic children. Of the 20 patients who tested positive for COVID-19, only 3 were female.
Only one patient with COVID-19 illness required non-critical care hospitalization for COVID-19 associated symptoms. All other pediatric patients had mild disease symptoms and were managed at home. Of the 74 adult caregivers tested, 13 caregivers of 10 patients were found to be positive for COVID-19, including a 14.7% rate of COVID-19 infection in asymptomatic caregivers. Only half of the patients with COVID-19 positive caregivers were themselves also COVID-19 positive, suggesting low infectivity in children despite close household contacts.
While the overall numbers in the study are small, the data confirms that the overall morbidity of COVID-19 illness in pediatric cancer patients is low with only 5% requiring hospitalization for symptoms of COVID-19 infection; and that the rate of COVID-19 infection among asymptomatic pediatric patients is very low.
GRYT Health and BMS launch COVID-19 Advocacy Exchange
GRYT Health and Bristol Myers Squibb Co. developed the COVID Advocacy Exchange, a virtual platform to connect patient advocacy organizations, patients, policy makers, healthcare practitioners, and industry in the exchange of information.
The COVID Advocacy Exchange will invite close to 100 global and local advocacy organizations, spanning disease states, to virtually meet and support patients with serious diseases while navigating the current COVID-19 pandemic. The virtual platform will provide access to data and information, as well as the opportunity to participate in weekly live, interactive sessions to foster discussion and collaboration.
The virtual platform will provide advocacy organizations and patients with access to materials and information offering support across the following disease areas: oncology, cardiovascular, immunology & fibrosis, hematology and multiple sclerosis. Participants will have access to materials from Bristol Myers Squibb, other advocacy organizations and third-party experts, including curated best practices, white papers, peer-reviewed articles and multimedia content addressing the unique advocacy challenges associated with the COVID-19 pandemic for advocates and patients. Resources to address digital fundraising and other issues exacerbated by the pandemic will also be available.
Exhibitor information and the first weekly live, interactive session will be available here, launching the week of May 18. To register for free access to the platform and the series, visit www.covidadvocacyexchange.com.