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Purpose To estimate the clinical and economic benefits of lenzilumab plus standard of care (SOC) compared with SOC alone in the treatment of hospitalized COVID-19 patients from the National Health Service (NHS) England perspective. Methods A cost calculator was developed to estimate the clinical benefits and costs of adding lenzilumab to SOC in newly hospitalized COVID-19 patients over 28 days. The LIVE-AIR trial results informed the clinical inputs: failure to achieve survival without ventilation (SWOV), mortality, time to recovery, intensive care unit (ICU) admission, and invasive mechanical ventilation (IMV) use. Base case costs included drug acquisition and administration for lenzilumab and remdesivir and hospital resource costs based on the level of care required. Clinical and economic benefits per weekly cohort of newly hospitalized patients were also estimated. Results In all populations examined, specified clinical outcomes were improved with lenzilumab plus SOC over SOC treatment alone. In a base case population aged <85 years with C-reactive protein (CRP) <150 mg/L, with or without remdesivir, adding lenzilumab to SOC was estimated to result in per-patient cost savings of £1162. In a weekly cohort of 4754 newly hospitalized patients, addition of lenzilumab to SOC could result in 599 IMV uses avoided, 352 additional lives saved, and over £5.5 million in cost savings. Scenario results for per-patient cost savings included: 1) aged <85 years, CRP <150 mg/L, and receiving remdesivir (£3127); 2) Black patients with CRP <150 mg/L (£9977); and 3) Black patients from the full population (£2369). Conversely, in the full mITT population, results estimated additional cost of £4005 per patient. Conclusion Findings support clinical benefits for SWOV, mortality, time to recovery, time in ICU, time on IMV, and ventilator use, and an economic benefit from the NHS England perspective when adding lenzilumab to SOC for hospitalized COVID-19 patients.

of breast cancer (BC) and cervical cancer (CC) patients (pts) during their first consultation, comparing the periods during and prior to the pandemic. Methods: Data were collected from pts who started follow-up and treatment in a cancer center in Brazil from Sep/20-Jan/21 and from Sep/19-Jan/20. These periods were selected considering the beginning and duration of the COVID-19 pandemic in Brazil, which started on Feb/20 and is still ongoing. We considered the period (Sep/ 20-Jan/21) to be representative of the pandemic impact on cancer diagnosis. The primary endpoint was BC and CC stages at diagnosis. CC staging was defined according to 2018 FIGO staging. Clinical or pathological (for those with upfront surgery) BC stage was defined according to the TNM anatomic stage from AJCC 8th edition. The comparison of cancer stages between the two periods was performed using Chi-Square test.Results: 268 BC pts and 44 CC pts had their first consult from Sep/20-Jan/21; 457 and 60, respectively, occurred from Sep/19-Jan/20. Pts who attended their first consult during the pandemic period presented with higher BC (P<0.001) and CC (P¼0.328) stages than those prior to the pandemic, although the difference was not statistically significant for cervical cancer. The proportion of CC pts diagnosed with locally advanced disease (stages III-IVA) was 56.8% (N¼25) in Sep/20-Jan/21 compared to 43.3% (N¼26) in Sep/19-Jan/20. Similarly, 37.3% (N¼100) of BC pts had stage III disease in Sep/20-Jan/21 compared to 23.2% (N¼106) in Sep/19-Jan/20. Fewer pts were diagnosed with stage I BC during the pandemic (9.3% vs 20.6%). Additionally, fewer BC pts were diagnosed due to screening tests during the pandemic (13.7%; N¼36) than before it (25.5%; N¼113) (P<0.001).Conclusions: BC and CC pts presented with a higher stage in their first consultation at a cancer center during the period of the COVID-19 pandemic compared to a similar period prior to the pandemic, confirming the long-term negative impact of the pandemic for oncologic pts. Thus, efforts should be made not to compromise essential cancer services.Legal entity responsible for the study: The authors.

RATIONALE: The hyperinflammatory immune response of COVID-19, in part orchestrated by granulocyte-macrophage colony-stimulating factor (GM-CSF) can lead to respiratory failure and death with disparities in outcomes between racial subgroups. In the LIVE-AIR trial, the GM-CSF neutralizing antibody lenzilumab improved survival without mechanical ventilation (SWOV) in COVID-19. OBJECTIVE: An analysis of outcomes was performed to determine differences between Black/African American (B/AA) and White participants in LIVE-AIR. METHODS: LIVE-AIR was a phase 3, randomized, double-blind, placebo-controlled trial. Participants hospitalized with COVID-19 pneumonia were randomized 1:1 to receive lenzilumab (1800 mg total) or placebo in addition to standard of care, including remdesivir and/or corticosteroids. MEASUREMENTS AND MAIN RESULTS: Lenzilumab, compared to placebo, numerically improved the likelihood of SWOV (primary endpoint) in B/AA (n=71; 86.8% vs 70.9%; HR, 2.68; 95% confidence interval [CI], 0.88-8.11; p=0.0814) and White (n=343; 85.1% vs 80.8%; HR, 1.41; 95%CI, 0.85-2.35, p=0.182) participants. A statistically significant improvement in SWOV was observed in B/AA (HR: 8.9; 95%CI: 1.08, 73.09; p=0.0418) and White (HR: 2.32; 95%CI: 1.17, 4.61; p=0.0166) participants with baseline CRP<150 mg/L. Lenzilumab numerically, but not statistically, improved secondary endpoints of IMV, ECMO or mortality; ventilator-free days; ICU days and time to recovery in either race while ventilator-free days, ICU days, and time to recovery were statistically improved in B/AA participants with baseline CRP<150 mg/L. Lenzilumab was well tolerated without differences in serious adverse events regardless of race. CONCLUSION: Lenzilumab significantly improved SWOV and some key secondary outcomes in B/AA COVID-19 participants with baseline CRP<150 mg/L. NCT04351152

Aims: The study estimated the clinical benefits and budget impact of lenzilumab plus standard of care (SOC) compared with SOC alone in the treatment of hospitalized COVID-19 patients from the United States hospital perspective. Materials and Methods: An economic model was developed to estimate the clinical benefits and costs for an average newly hospitalized COVID-19 patient, with a 28-day time horizon for the index hospitalization. Clinical outcomes from the LIVE-AIR trial included failure to achieve survival without ventilation (SWOV), mortality, time to recovery, intensive care unit (ICU) admission, and invasive mechanical ventilation (IMV) use. Base case costs included drug acquisition and administration for lenzilumab and hospital resource costs based on the level of care required. The inclusion of 1-year rehospitalization costs was examined in a scenario analysis. Results: In the base case and all scenarios, treatment with lenzilumab plus SOC improved all specified clinical outcomes over SOC alone. Adding lenzilumab to SOC was also estimated to result in cost savings of $3,190 per patient in a population aged <85 years with CRP <150 mg/L and receiving remdesivir (base case). Per-patient cost savings were also estimated in the following scenarios: 1) aged <85 years with CRP <150 mg/L, with or without remdesivir ($1,858); 2) Black and African American patients with CRP <150 mg/L ($13,154); and 3) Black and African American patients from the full population ($2,763). In the full mITT population, a budget impact of $4,952 was estimated. When adding rehospitalization costs to the index hospitalization, a total per-patient cost savings of $5,154 was estimated. Conclusions: The results highlight the clinical benefits for SWOV, ventilator use, time to recovery, mortality, time in ICU, and time on IMV, in addition to a favorable budget impact from the United States hospital perspective associated with adding lenzilumab to SOC for patients with COVID-19 pneumonia.