Search This Blog

Monday, August 31, 2020

Which Cancer Patients are Most Susceptible to Severe Effects from COVID-19

It’s well known that COVID-19 patients with comorbidities have poorer outcomes than otherwise healthy patients. When it comes to cancer, however, the risk of death from COVID-19 also varies by tumor subtype. Research published in Lancet Oncology August 24th analyzed that risk by tumor subtype and patient demographics, looking at 1,044 patients from 60 medical centers throughout the UK.

“For the first time, we have a comprehensive analysis to determine who is more at risk of COVID-19,” Lennard Lee, DPhil, academic clinical lecturer, University of Oxford, said of the study.

As Lee and colleagues from the University of Oxford and the University of Birmingham noted in the paper, “Patients with hematological malignancies (leukemia, lymphoma, and myeloma) had a more severe COVID-19 trajectory compared with patients with solid organ tumors.” Those who recently had undergone chemotherapy faced a further, heightened risk of mortality.

Cancer patients with the least risk from COVID-19 were those with lung cancer and prostate cancer. A single variable analysis of the 1,044-patient UK Coronavirus Cancer Monitoring Project (UKCCMP) also showed a significantly lower risk of death for patients for breast cancer (0.53%) and female genital cancers (0.36%), but a significantly higher risk of death from COVID-19 among patients with prostate cancer (2.14%) and leukemia (2.3%).

As part of the study, researchers developed a chart comparing cancer types of patient with COVID-19 with the overall cancer incidence in the UK, as listed in the UK Office for National Statistics (ONS) database. It shows the average increased risk for those with leukemia was 2.82%, for myeloma 2.03%, and for lymphoma 1.63%.

When age and gender were considered, the fatality rate for those with COVID-19 and leukemia remained high, at 2.25%. Notably, under that multivariable analysis, prostate cancer was no longer associated with increased fatalities. However, breast and female genital cancers were no longer associated with reduced fatality rates. “This highlight(s) the effect of patient age and sex of case-fatality rate,” according to the researchers, co-led by Gary Middleton (University Hospitals Birmingham), Rachel Kerr (Oxford University Hospitals), and Lennard Lee (University of Oxford). 

“Using these new data, we are working fast to identify trends and correlations that will enable us to create a tiered risk assessment tool so we can more precisely define the risk to a given cancer patient and move away from a blanket ‘vulnerable’ policy for all cancer patients, in the event of a second wave of COVID-19,” Rachel Kerr, FRCP, study senior researcher, University of Oxford, said.

A review of the UKCCMP database showed that nearly 57% of the patients who had both COVID-19 and cancer were male, compared to slightly more than 51% of all cancer patients listed on the ONS database.

The study also confirmed that increased risk of morbidity and mortality for patients who are older, male (vs female), and have comorbidities, such as hypertension, chronic lung disease, diabetes, and cancer. The average age of all patients was 70. Of the 1,044 patients in the UKCCMP cohort, 319 died. For 295 of those (92.5%) the cause of death was listed as COVID-19.

While correlating COVID-19 risks for patients with specific cancer is scientifically interesting, it is the practical implication that offer the greatest value. As the study reported, “Patients with hematological malignancies were significantly more likely to require high flow oxygen, non-invasive ventilation, intensive care unit admission for ventilation and have a severe or critical disease course.” Nearly half (47.6%) had received chemotherapy within the prior four weeks, compared to nearly 30% (29.5%) of patients with other types of malignancies. Ddministration of chemotherapy was associated with a 2.09% increased risk of death during COVID-19-asociated hospitalization.

In discussing possible reasons for the linkages between recent chemotherapy for hematologic cancer and death among COVID-19 patients, the authors suggested the immunological disruption and intense myelosuppressive treatments for the cancer might allow and environment that enabled the SARS-CoV-2 virus to gain a foothold in the host, and then to progress and unleash a cytokine storm.

The overrepresentation of hematological malignancies in the UKCCMP database also may suggest increased susceptibility to viral infection, the researchers speculated. They also noted the overrepresentation of patients with “extranodal natural killer/T-cell lymphoma (ICD-10 code C86), Waldenström macroglobulinaemia (C88), and unspecified neoplasm of lymphoid, hematopoietic, and related tissue (C96). The reasons for this are unclear,” they wrote.

The researchers are careful to point out the difficulty of attributing a direct cause of death for patients with both cancer and COVID-19. Even scientific literature regarding COVID-19 and cancer shows disagreement. Some studies support this correlation and others report no correlation between chemotherapy and mortality cancer patients who have contracted COVID-19. The list of potential causes of such variations is long, and includes under- or over-representation of subgroups in the various studies, methodological differences, and early protection of some patient groups, as well as low admission rates to hospitals for patients in hospice care or nursing homes.

By correlating the type of cancer to morbidity and mortality risks, the researchers hope to enable oncologists to have better-informed risk-benefit discussions with their patients, especially since cancer management has changed during the pandemic to decrease patients’ risks of contracting COVID-19. “It is important to note that whilst cancer patients are more vulnerable, the chance of any given patient getting infected with COVID-19 remains low,” Lee emphasized.


Quiet period ends on Acutus Medical; stock rallies on analysts ratings

Analyst coverage opens up on Acutus Medical (AFIB +14.1%).

William Blair launches the online marketplace stock with a Outperform rating. Analyst Margaret Kaczor estimates sales of $11.8M in 2020, $55M in 2021, and $125.4M in 2022; he believes better outcomes—particularly for hard-to-treat cases—a better patient/care team experience, and a lower cost to treat should lead to a 120% sales CAGR through 2022.

“Acutus is poised to take share and expand the $5.7B global cardiac ablation market,” Kaczor added.

JPMorgan Chase sets an Overweight rating and price target of $39. Buy ratings have been initiated by Bank of America (PT, 38), BTIG Research (PT, 40) and BofA Securities (PT, 38). Cautious ratings are in from Canaccord Genuity (Hold).


FDA Ad Com thumbs down on mortality benefit claim for Glaxo’s Trelegy Ellipta

The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 14-1 that the results from the IMPACT study evaluating GlaxoSmithKline’s (GSK +0.2%) Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation) in chronic obstructive pulmonary disease (COPD) patients do not provide sufficient evidence to support the proposed claim of a reduction in all-cause mortality.

The FDA approved the product in September 2017 for COPD.



FDA OKs Medtronic automated insulin system for young kids

The FDA approves Medtronic’s (NYSE:MDT) MiniMed 770G System, a hybrid closed-loop diabetes management device, for children ages 2 – 6 with type 1 diabetes, the first such system available in the U.S. for this population of children.

The system, a bluetooth-enabled version of the MiniMed 670G, measures blood sugar levels every five minutes and automatically adjusts insulin delivery.

At mealtime, users must manually request insulin doses to counter carbohydrate consumption.


AstraZeneca backs safety guides in development of COVID-19 vaccine

In a statement, AstraZeneca (NYSE:AZN) reemphasizes its commitment to the highest safety standards and broad equitable global access to COVID-19 vaccine AZD1222, adding that its marketing applications will meet the stringent requirements by regulators around the world.

Its development plan aims to enroll more than 50K volunteers, including 30K in the U.S., Latin America, Asia, Europe, Russia and Africa.

AZD1221, co-invented by the University of Oxford and its spin-out company Vaccitech, is based on a weakened adenovirus vector containing genetic material of the SARS-CoV-2 virus spike protein.

The intense global race to commercialize a legitimate vaccine against the coronavirus has many observers worried that over-eager governments may sign off based on insufficient supporting data, exemplified by Russia’s approval of a vaccine, dubbed Sputnik V, based on results from less than 60 volunteers.


Bayer to buy vitamin firm Care/Of in deal valued at $225M

August 31, 2020

Bayer (OTCPK:BAYRY) has agreed to buy 70% of online vitamin and health supplement company Care/of in a deal that values the company at $225M, with an option to buy the rest by 2022, Bloomberg reports.
Bayer believes “this model and product type has the ability to expand into traditional retail channels as we aim to reach new consumers,” the company says, adding it will “grow the Care/of business across new channels, new categories and new markets to deliver even more personalized nutrition.”
The latest deal follows Bayer’s agreement earlier this month to buy British women’s health biotech Kandy Therapeutics in an $875M deal.

Axsome has development plans on AXS-05 for Alzheimer’s agitation

Axsome Therapeutics (AXSM -2.7%) confirms pivotal development status and plan for AXS-05 in the treatment of Alzheimer’s disease (AD) agitation following a successful Breakthrough Therapy meeting with the FDA.

AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is an oral, investigational NMDA receptor antagonist and sigma-1 receptor agonist. There is currently no approved treatment for AD agitation.

Results of the meeting confirm the pivotal status of the previously completed positive ADVANCE-1 trial, and the establishment of the superiority of AXS-05 over its components.

Consequently, only one additional Phase 3 efficacy trial will be needed to support the NDA filing for approval of AXS-05 in this indication, and only a placebo control will be required.

Axsome is on track to initiate this efficacy trial in Q4. The Company also plans to launch an open-label safety extension trial of AXS-05 in AD agitation patients in Q4 to supplement the existing AXS-05 long-term safety database.