Mortality of 1,636 COVID-19 cancer patients (pts) and associated prognostic factors

Background: We assessed mortality risk by COVID-19 (C19) infection among treated cancer patients (pts) and the impact of anti-cancer treatment (tx) on mortality. Methods: Optum de-identified Electronic Health Record dataset (2021-01-07 release) were used to find cancer pts with a C19 positive (ICD-9/10-CM codes U071/U072 or positive test result) or negative (negative test and no positive test at any time after the first negative result) status on the first test/diagnosis date (ie the “index date”). Pts with <1 year database history, with no tx 0-90 days before index, <18 years old, with implausible death dates, and with index dates outside of 02/2020 - 11/2020 were excluded. C19 positive and negative pts were exact-matched on cancer type, then 1:1 nearest-neighbor matched on propensity scores (variables in table). Missing values were imputed (n = 5), and outcomes were evaluated by multivariable logistic regression, including interaction terms between tx and C19 positivity. Results: We identified 21,060 pts, of whom 1,636 (7.8%) were positive for C19 and 19,424 (92.2%) negative. Among 1,636 matched pairs of positive/negative C19 pts, the odds ratio (OR) of 30-day mortality comparing C19 positive vs negative patients was 2.14 (95% CI: 0.71 – 6.52). Among the strongest predictors of 30-day mortality were age 75+ (OR = 5.42, 95% CI: 2.21 – 13.28), inpatient C19 testing/diagnosis (OR = 4.78, 95% CI: 3.04, 7.53), CCI of 3+ (OR = 2.24, 95% CI: 1.30 – 3.89), and metastatic disease (OR = 1.80, 95% CI 1.21 – 2.68). Anti-cancer therapies do not appear to modulate risk of death due to C19. Beyond 30-day mortality, matched mortality rate ratios (MRRs) suggested increased risk for C19 positive patients (MRR = 1.85, 95% CI: 1.26 – 2.44). [Formula presented] Conclusions: C19 showed a trend towards increased 30-day mortality risk (not statistically significant), and increased overall mortality risk. Specific tx did not appear to modulate 30-day mortality due to C19. Legal entity responsible for the study: Genentech, Inc. Funding: Roche/Genentech. Disclosure: P.A. Ascierto: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Roche-Genentech, Merck Sharp & Dohme, Novartis, Array, Merck Serono, Pierre-Fabre, Incyte, Medimmune, AstraZeneca, Syndax, Sun Pharma, Sanofi, Idera, Ultimovacs, Sandoz, Immunocore, 4SC, Alkermes, Italfarmaco, Nektar, Boehringer Ingelheim;Financial Interests, Personal, Research Grant: Bristol Myers Squibb, Roche-Genentech, Array, Sanofi;Financial Interests, Personal, Other: MSD;Non-Financial Interests, Personal, Advisory Board: TAKIS. M.H. Secrest: Financial Interests, Personal, Full or part-time Employment: Roche/Genentech;Financial Interests, Personal, Stocks/Shares: Roche. P. Lambert: Financial Interests, Personal, Full or part-time Employment: Genentech/Roche;Financial Interests, Personal, Stocks/Shares: Roche. K. Sarsour: Financial Interests, Personal, Full or part-time Employment: Roche/Genentech;Financial Interests, Personal, Stocks/Shares: Roche. A. Tan: Financial Interests, Personal, Full or part-time Employment: Roche/Genentech;Financial Interests, Personal, Stocks/Shares: Roche. R. Walls: Financial Interests, Personal, Full or part-time Employment: Hoffmann-La Roche;Financial Interests, Personal, Stocks/Shares: Hoffmann-La Roche. J. Reddy: Financial Interests, Personal, Full or part-time Employment: Roche/Genentech;Financial Interests, Personal, Stocks/Shares: Roche. A. Seetasith: Financial Interests, Personal, Full or part-time Employment: Genentech, Inc.;Financial Interests, Personal, Stocks/Shares: Roche. D. Shenison: Financial Interests, Personal, Full or part-time Employment: Roche/Genentech;Financial Interests, Personal, Stocks/Shares: Roche, Cigna. I. Ngwa: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann - La Roche Ltd;Financial Interests, Personal, Stocks/Shares: F. Hoffmann - La Roche Ltd. C. Yun: Financial Interests, Personal, Full or part-time Employment: Genentech, Inc.;Financial Interests, Personal, Stocks/Shares: Roche. Q. Zhang: Financial Interests, Personal, Full or part-time Employment: Roche/Genentech;Financial Interests, Personal, Stocks/Shares: Roche, Regeneron, BMS, AbbVie, AC Immune.

Clinical characteristics and outcomes ofcoronavirus 2019 disease (COVID-19) in cancer patientstreated with immune checkpoint inhibitors (ICI)

Background: ICI are widely used in the treatment of various cancer types. It has been hypothesized that ICI couldconfer an increased risk of severe acute lung injury or other complications associated with severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2). Methods: We analyzed data from 113 patients with laboratory-confirmed COVID-19 while on treatment with ICI without chemotherapy in 19 hospitals in North America, Europe, and Australia. Data collected included details onsymptoms, comorbidities, medications, treatments and investigations for COVID-19, and outcomes (hospitaladmission, ICU admission, and mortality). Results: The median age was 63 years (range 27-86);40 (35%) patients were female. Most common malignancies were melanoma (n=64, 57%), non-small cell lung cancer (n=19, 17%), and renal cell carcinoma (n=11, 10%);30(27%) patients were treated for early (neoadjuvant/adjuvant) and 83 (73%) for advanced cancer. Most patientsreceived anti-PD-1 (n=85, 75%), combination anti-PD-1 and anti-CTLA-4 (n=15, 13%), or anti-PD-L1 (n=8, 7%) ICI.Comorbidities included cardiovascular disease (n=31, 27%), diabetes (n=17, 15%), and pulmonary disease (n=14, 12%). Symptoms were present in 68 (60%) patients;46 (68%) had fever, 40 (59%) cough, and 23 (34%) dyspnea.Overall, ICI was interrupted in 58 (51%) patients. At data cutoff, 33 (29%) patients were admitted to hospital, 6 (5%)to ICU, and 9 (8%) patients died. COVID-19 was the primary cause of death in 7 patients, 3 of whom were admittedto ICU. Cancer types in patients who died were melanoma (2), non-small cell lung cancer (2), renal cell carcinoma(2), and others (3);all (9) patients had advanced cancer. Administered treatments were oxygen therapy (8), mechanical ventilation (2), vasopression (2), antibiotics (7), antiviral drugs (4), glucocorticoids (2), and anti-IL-6 (2).Of all hospitalized patients, 20 (61%) had been discharged and 4 (12%) were still in hospital at data cutoff. Conclusion: The mortality rate of COVID-19 in patients on ICI is higher than rates reported for the generalpopulation without comorbidities but may not be higher than rates reported for the cancer population. Despite thesepreliminary findings, COVID-19 patients on ICI may not have symptoms and a proportion may continue ICI.Correlative analyses are ongoing and will be presented.