Single agent and combination checkpoint inhibitors therapy: A post marketing safety analysis.

125 Background: Immune Checkpoint Inhibitors (ICIs) are used to treat patients with a wide spectrum of malignancies. Individuals enrolled in clinical trials are usually more fit compared to patients seen in everyday practice. Therefore, it is important to evaluate the safety profile of these agents in real-world data. In addition, it is not clear if the safety of these agents is similar across all age groups. Methods: We reviewed the FDA Adverse Event Reporting System (FAERS) for adverse events associated with the use of PD-1 inhibitors (nivolumab and pembrolizumab); PD-L1 inhibitor (atezolizumab); and CTLA-4 inhibitor (ipilimumab). Our analysis was restricted to reports that included only an ICI as a suspect agent. For each agent, we performed a descriptive analysis of hospitalization (HO) and death (DE) outcomes, as well as select adverse events of special interest (AESI). We compared the distribution of each outcome within age groups ( < 65 years; 67-75; > 75) using Mantel-Haenszel chi -quare test for trend. Results: A total of 23,586 safety reports were included in our analysis. 415 for atezolizumab, 10,026 for nivolumab, 4,808 for pembrolizumab, 6,339 for ipilimumab, and 1,988 for the combination nivolumab plus ipilimumab. Increased age was associated with a statistically significant trend of more hospitalizations for all drugs except for the combination nivolumab plus ipilimumab where hospitalization rate was high ( > 80%) but similar across all age groups. Prevalence of any of the AESI was higher as age increased for all drugs (p < 0.0001) except for atezolizumab (p 0.12) and combination nivolumab plus ipilimumab (p 0.488). Proportion of older patients who experienced death was higher for pembrolizumab (p < 0.001), ipilimumab (p 0.002), and combination nivolumab plus ipilimumab (p < 0.001). Conclusions: Our analysis suggests that among patients treated with ICI, older individuals receiving pembrolizumab, Nivolumab or ipilimumab were more likely to develop immune related AEs, and to be hospitalized. An increased rate of death with higher age was seen with the use of pembrolizumab, ipilimumab, and combination nivolumab + ipilimumab. Older patients treated with ICIs should be monitored carefully for treatment-related AEs.

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Cardiovascular safety profile of taxanes and vinca alkaloids: 30 years FDA registry experience

Open Heart ◽

10.1136/openhrt-2021-001849 ◽

2021 ◽

Vol 8 (2) ◽

pp. e001849

Author(s):

Akshee Batra ◽

Brijesh Patel ◽

Daniel Addison ◽

Lauren A Baldassarre ◽

Nihar Desai ◽

...

Keyword(s):

Combination Therapy ◽

Adverse Events ◽

Kinase Inhibitors ◽

Checkpoint Inhibitors ◽

Single Agent ◽

Adverse Event Reporting System ◽

Vinca Alkaloid ◽

Chemotherapeutic Agents ◽

Vinca Alkaloids ◽

Cardiovascular Assessment

ObjectiveAntimicrotubular agents are among the most commonly used classes of chemotherapeutic agents, but the risk of cardiovascular adverse events (CVAEs) remains unclear. Our objective was to study the CVAEs associated with antimicrotubular agents.MethodsThe Food and Drug Administration’s Adverse Event Reporting System was used to study CVAEs in adults from 1990 to 2020. Reported single-agent (only taxane or vinca alkaloid) CVAEs were compared with combination therapy (with at least one of the four major cardiotoxic drugs: anthracycline, HER2Neu inhibitors, tyrosine kinase inhibitors and checkpoint inhibitors) using adjusted polytomous logistic regression.ResultsOver 30 years, 134 398 adverse events were reported, of which 18 426 (13.4%) were CVAEs, with 74.1% due to taxanes and 25.9% due to vinca alkaloids. In 30 years, there has been a reduction in the proportion of reported CVAEs for taxanes from 15% to 11.8% (Cochran-Armitage P-trends <0.001) with no significant change in the proportion of reported CVAEs for vinca alkaloids (9.2%–11.7%; P-trends=0.06). The proportion of reported CVAEs was lower in both taxane and vinca alkaloid monotherapy versus combination therapy (reporting OR=0.50 and 0.55, respectively). Anthracyclines and HER2Neu inhibitor combinations with taxanes or vinca alkaloids primarily drove the higher burden of combination CVAEs. Hypertension requiring hospitalisation and heart failure was significantly lower in monotherapy versus combination antimicrotubular agent therapy.ConclusionsAntimicrotubular agents are associated with CVAEs, especially in combination chemotherapy regimens. Based on this study, we suggest routine cardiovascular assessment of patients with cancer before initiating antimicrotubular agents in combination therapy.

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Immune checkpoint inhibitors-related myocarditis in patients with cancer: an analysis of international spontaneous reporting systems

BMC Cancer ◽

10.1186/s12885-020-07741-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Rulan Ma ◽

Quanziang Wang ◽

Deyu Meng ◽

Kang Li ◽

Yong Zhang

Keyword(s):

Immune Checkpoint ◽

Immune Checkpoint Inhibitors ◽

Adverse Drug Events ◽

Cytotoxic T Lymphocyte ◽

Checkpoint Inhibitors ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Reporting Odds Ratio ◽

Real World Data ◽

Safety Issues

Abstract Background Immune checkpoint inhibitors-induced myocarditis presents unique clinical challenges. Here, we assessed post-marketing safety of cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death-1 (PD-1), and programmed death-ligand 1 (PD-L1) inhibitors by mining the real-world data reported in two international pharmacovigilance databases. Methods We analyzed immune checkpoint inhibitors (ICIs)-associated fatal adverse drug events (ADEs) reports from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) collected from July 1, 2014 to December 31, 2019 and data from EudraVigilance (EV) database accessed on February 29, 2020. Three different data mining approaches were used to detect the signal of fatal myocarditis caused by ICIs. Results Based on 7613 ICIs-related ADEs reported to the EV database and 5786 ICIs-associated ADEs submitted to the FAERS database, the most frequently reported ADE was ipilimumab-related colitis. For myocarditis, nivolumab-associated myocarditis was the most common. Among the five fatal toxic effects associated with ICIs, the lethality rate of myocarditis was the highest. Therefore, we further analyzed ICI-associated myocarditis and found that elderly patients and male patients were more likely to develop ICIs-related myocarditis. The results of signal detection showed that the risk signal of avelumab-related myocarditis detected by reporting odds ratio (ROR) method and proportional reporting ratios (PRR) method was the highest, whereas the signal strength of ipilimumab-related myocarditis detected by Bayesian confidence propagation neural networks (BCPNN) method was the strongest. Conclusion The findings of this study indicated the potential safety issues of developing myocarditis when using ICIs, which were consistent with the results of previous clinical trials and could provide a reference for clinical workers when using ICIs.

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Immune checkpoint inhibitors-related myocarditis in patients with cancer: an analysis of international spontaneous reporting systems

10.21203/rs.3.rs-40795/v2 ◽

2020 ◽

Author(s):

Rulan Ma ◽

Quanziang Wang ◽

Deyu Meng ◽

Kang Li ◽

yong zhang

Keyword(s):

Immune Checkpoint ◽

Immune Checkpoint Inhibitors ◽

Adverse Drug Events ◽

Cytotoxic T Lymphocyte ◽

Checkpoint Inhibitors ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Reporting Odds Ratio ◽

Real World Data ◽

Safety Issues

Abstract Background: Immune checkpoint inhibitors induced myocarditis presents unique clinical challenges. Here, we assessed post-marketing safety of cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), programmed cell death-1 (PD-1), and programmed death-ligand 1 (PD-L1) inhibitors by mining the real-world data reported in two international pharmacovigilance databases. Methods: We analyzed immune checkpoint inhibitors (ICIs)-associated fatal adverse drug events (ADRs) reports from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) collected from July 1, 2014 to December 31, 2019 and data from EudraVigilance (EV) database accessed on February 29, 2020. Three different data mining approaches were used to detect the signal of fatal myocarditis caused by ICIs. Results: Based on 7613 ICIs-related ADEs reported to the EV database and 5786 ICIs-associated ADEs submitted to the FAERS database, the most frequently reported ADE was ipilimumab-related colitis. For myocarditis, nivolumab-associated myocarditis was the most common. Among the five fatal toxic effects associated with ICIs, the lethality rate of myocarditis was the highest. Therefore, we further analyzed ICI-associated myocarditis and found that elderly patients and male patients were more likely to develop ICIs-related myocarditis. The results of signal detection showed that the risk signal of avelumab-related myocarditis detected by reporting odds ratio (ROR) method and proportional reporting ratios (PRR) method was the highest, whereas the signal strength of ipilimumab-related myocarditis detected by Bayesian confidence propagation neural networks (BCNPP) method was the strongest. Conclusion: The findings of this study indicated the potential safety issues of developing myocarditis when using ICIs, which are consistent with the results of previous clinical trials and can provide a reference for clinical workers when using ICIs.

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Efficacy and Adverse Events of Immunotherapy with Checkpoint Inhibitors in Older Patients with Cancer

Drugs & Aging ◽

10.1007/s40266-019-00697-2 ◽

2019 ◽

Vol 36 (10) ◽

pp. 927-938 ◽

Cited By ~ 14

Author(s):

Yara van Holstein ◽

Ellen Kapiteijn ◽

Esther Bastiaannet ◽

Frederiek van den Bos ◽

Johanneke Portielje ◽

...

Keyword(s):

Adverse Events ◽

Older Patients ◽

Checkpoint Inhibitors ◽

Patients With Cancer

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Imatinib in the Treatment of CML Patients ≥ 65 Years Old in Late Chronic Phase: Results of a Phase II Study of the GIMEMA CML Working Party.

Blood ◽

10.1182/blood.v104.11.2935.2935 ◽

2004 ◽

Vol 104 (11) ◽

pp. 2935-2935

Author(s):

Simona Bassi ◽

Fausto Castagnetti ◽

Marilina Amabile ◽

Barbara Giannini ◽

Daniela Cilloni ◽

...

Keyword(s):

Adverse Events ◽

Older Patients ◽

Age Groups ◽

Chronic Phase ◽

Working Party ◽

Cytogenetic Response ◽

Term Survival ◽

Grade Iii ◽

Two Age Groups

Abstract Older age constitutes a poor prognostic variable in CML patients: the negative effect of age on long-term survival has been consistently observed with most effective therapeutic modalities, both drug therapies (busulfan, hydroxyurea and interferon) and allogeneic transplant. In particular, older patients treated with interferon experienced much more adverse events than younger ones. In part their poorer prognosis was probably due to poor treatment compliance and few older patients have been included in prospective studies of interferon. Actually, imatinib is the first-line treatment for CML: its efficacy is very high and it seems to be well tolerated across age groups. We performed a sub-analysis of the effects of age on response and tolerance within the phase II trial of the italian GIMEMA CML Working Party (serial n.CML/002/STI571), which included 284 late chronic phase patients, treated with imatinib (400 mg daily) after interferon failure. Following the WHO, who defines “old” a patient ≥ 65 years, we analyzed the safety and efficacy of imatinib by age group: 226/284 patients (80%) were < 65 years (extr. 17–64) and 58/284 (20%) were ≥ 65 years (extr. 65–85 yrs) old. No significant differences between the two age groups were present at enrollment. Table 1 shows the responses and incidence of hematologic and non-hematologic adverse events (AEs). As expected, older patients experienced more AEs, both hematologic and non-hematologic. In part this significantly poorer tolerance probably justifies the lower response rates, both hematologic and cytogenetic. However, the overall survival was not different between the two age groups: with a median observation time of 33 months, the overall survival curves were superimposed (91%). Moreover, the rate of progression to accelerated/blastic phase was the same (10%). This study demonstrates that imatinib is greatly effective in older CML patients in late chronic phase (53% of MCR and 36% of CCR) and allows a good long-term survival. It is conceivable that treating old CML patients at the onset of the disease, as already shown by Jorge Cortes et al (Cancer2003;98:1105), could translate into response rates as the ones of younger patients. Responses and adverse events ≥ 65 (n. 58) ≤ 65 (n226) p value Complete Hematologic response 91% 99% 0,001 Major Cytogenetic Response 53% 74% 0,003 Complete Cytogenetic Response 36% 57% 0,001 Grade III Hematologic AEs 72% 50% 0,002 Grade III+IV Hematologic AEs 86% 60% 0,0001 Grade II non Hematologic AEs 83% 68% 0,0001 Grade III + IV non Hematologic AEs 29% 10% 0,0001

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Multiple immune-related adverse events and anti-tumor efficacy: real-world data on various solid tumors

10.21203/rs.2.21095/v1 ◽

2020 ◽

Author(s):

Keitaro Shimozaki ◽

Yasutaka Sukawa ◽

Noriko Beppu ◽

Isao Kurihara ◽

Shigeaki Suzuki ◽

...

Keyword(s):

Retrospective Study ◽

Adverse Events ◽

Real World ◽

Proportional Hazards ◽

Proportional Hazards Model ◽

Checkpoint Inhibitors ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

University Hospital ◽

Real World Data

Abstract Background Immune checkpoint inhibitors have been approved for various types of cancer; however, they cause a broad spectrum of immune-related adverse events (irAEs). The association between the development of irAEs and the clinical benefit remains uncertain. We aimed to evaluate the association of irAEs and the treatment efficacy in the real-world practice. Methods We conducted a retrospective study on patients with recurrent or metastatic non-small cell lung cancer, melanoma, renal cell carcinoma, or gastric cancer who received anti-PD-1/PD-L1 antibodies (nivolumab, pembrolizumab, or atezolizumab) at the Keio University Hospital between September 2014 and January 2019. We recorded treatment-related AEs from medical records and graded them using the Common Terminology Criteria for Adverse Events version 4. We performed an overall survival (OS) analysis using a Cox proportional hazards model. Results Among 212 patients eligible for this study, 108 experienced irAEs and 42 developed multiple irAEs. OS in patients with multiple irAEs was significantly longer than that in patients with single irAE (42.3 months vs. 18.8 months; hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.25–0.93; P = 0.03). Moreover, OS from the development of a second irAE in those with multiple irAEs was longer than that from the development of the first irAE in patients with single irAEs (median OS, 26.9 months vs. 17.7 months, respectively; HR, 0.59; 95% CI, 0.30–1.14; P = 0.11). Conclusions Our single-center retrospective study revealed a remarkable tendency associating the development of multiple irAEs with favorable prognoses.

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Common Immune-Related Adverse Events of Immune Checkpoint Inhibitors in the Gastrointestinal System: A Study Based on the US Food and Drug Administration Adverse Event Reporting System

Frontiers in Pharmacology ◽

10.3389/fphar.2021.720776 ◽

2021 ◽

Vol 12 ◽

Author(s):

Xiaoyin Bai ◽

Shiyu Jiang ◽

Yangzhong Zhou ◽

Hongnan Zhen ◽

Junyi Ji ◽

...

Keyword(s):

Adverse Events ◽

Odds Ratio ◽

Adjusted Odds Ratio ◽

Reporting System ◽

Checkpoint Inhibitors ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Event Reporting ◽

Logistic Analysis ◽

The Us

Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment; however, immune-related adverse events (irAEs) in the gastrointestinal (GI) system commonly occur. In this study, data were obtained from the US Food and Drug Administration adverse event reporting system between July 2014 and December 2020. Colitis, hepatobiliary disorders, and pancreatitis were identified as irAEs in our study. Reporting odds ratio (ROR) with information components (IC) was adopted for disproportionate analysis. A total of 70,330 adverse events were reported during the selected period, 4,075 records of which were associated with ICIs. GI toxicities have been reportedly increased with ICI, with ROR025 of 17.2, 6.7, and 2.3 for colitis, hepatobiliary disorders, and pancreatitis, respectively. The risks of colitis, hepatobiliary disorders, and pancreatitis were higher with anti-CTLA-4 treatment than that with anti-PD-1 (ROR025 2.6, 1.3, and 1.1, respectively) or anti-PD-L1 treatment (ROR025 4.8, 1.3, and 1.3, respectively). Logistic analysis indicated that hepatobiliary disorders and pancreatitis more frequently occurred in female patients (adjusted odds ratio, 1.16 and 1.52; both p < 0.05). Consistently, polytherapy was a strong risk factor for colitis (adjusted odds ratio 2.52, p < 0.001), hepatobiliary disorders (adjusted odds ratio 2.50, p < 0.001), and pancreatitis (adjusted odds ratio 2.29, p < 0.001) according to multivariate logistic analysis. This pharmacovigilance analysis demonstrated an increased risk of all three GI irAEs associated with ICI therapies. The comparative analysis offered supportive insights on selecting GI irAEs for patients treated with ICIs.

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Pericardial Toxicities Associated With Immune Checkpoint Inhibitors: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS) Database

Frontiers in Pharmacology ◽

10.3389/fphar.2021.663088 ◽

2021 ◽

Vol 12 ◽

Author(s):

Zhuo Ma ◽

Jie Pei ◽

Ximu Sun ◽

Lihong Liu ◽

Wenchao Lu ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Immune Checkpoint ◽

Immune Checkpoint Inhibitors ◽

Reporting System ◽

Checkpoint Inhibitors ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Interquartile Range ◽

Event Reporting

Introdution: Immune checkpoint inhibitors (ICIs) have significantly improved clinical outcomes for a wide range of cancers but can also lead to serious or fatal immune-related adverse events (irAEs). Although ICI-related pericardial toxicities have been reported, the clinical features are not well characterized in real-world studies.Objective: To characterize the main features of ICI-related pericardial toxicities and identify factors associated with death.Methods: Data from January 1, 2011 to March 31, 2020 in the FDA Adverse Event Reporting System database were retrieved for disproportionality analysis. We used the reporting odds ratio and the information component (IC) to evaluate the association between ICIs and pericardial adverse events. Clinical characteristics of patients with ICI-associated pericardial toxicities were collected and compared between fatal and non-fatal groups. The time to onset following different ICI regimens was further investigated.Results: We identified a total of 705 ICI-associated pericardial toxicities which appeared to influence more men (53.90%) than women (36.03%), with a median age of 63 (interquartile range [IQR] 54–69) years. Patients with lung cancer accounted for the largest proportion (55.6%). ICI therapies were detected with pharmacovigilance signals of pericardial toxicities, corresponding to IC025 = 2.11 and ROR 4.87 [4.51–5.25]. Nevertheless, there was a lack of association between anti-CTLA-4 and pericardial toxicities. There was no difference in onset time among all ICI regimens. However, TTO of fatal cases (25 days (interquartile range [IQR] 6–70)) occurred statistically earlier than non-fatal cases (42 days (IQR 12–114), p = 0.003).Conclusion: ICI monotherapy (PD-1/PD-L1 therapy) and combination therapy can lead to pericardial toxicities that can result in serious outcomes and tend to occur early. Early recognition and management of ICI-related pericardial disorders should attract clinical attention. The findings require further clinical surveillance for the quantification.

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Immune-related adverse events for different age groups using the FDA Adverse Event Reporting System.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e14256 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e14256-e14256

Author(s):

Zin Myint ◽

Ayman Qasrawi ◽

Richard O'Neal ◽

Chris Z Thomas ◽

Susanne M. Arnold ◽

...

Keyword(s):

Adverse Event ◽

Interstitial Lung Disease ◽

Adverse Events ◽

Lung Disease ◽

Reporting System ◽

Adverse Event Reporting System ◽

Age Groups ◽

Adverse Event Reporting ◽

Age Group ◽

Event Reporting

e14256 Background: Understanding immune-related adverse events (irAEs) for different age groups is crucial in the era of immunotherapy. The aim of our study is to assess the irAE profiles in different age groups (≤65 and > 65 years) for drugs that target PD1/PDL1, CTLA4, and their combination. Methods: Data were obtained from the FDA Adverse Event Reporting System database from Jan 2014 to Sep 2018. We extracted the data based on reported irAEs and reviewed 30 different irAEs including, but not limited to colitis, pneumonitis, interstitial lung disease (ILD), myocarditis and pneumonitis. Cases with missing data, another drug reported with the PD1/PDL1 or CTLA4 combinations, and duplicate cases were excluded. We calculated the reporting odds ratio (ROR) for irAE associated with the use of PD1/PDL1, CTLA4 and combination, respectively. Results: A total of 6197 reported irAEs cases were included: 3140 cases from patients ≤65 years and 3057 from > 65 years old. Colitis was the most common irAEs in both groups. The RORs (95% CI) in patients using CTLA4 alone, PD1/PDL1 alone or the combination were 4.17 (3.47-5.02), 0.6 (0.5-0.72), 1.98 (1.64-2.39) for colitis; 0.21 (0.09-0.52), 2.94 (1.97-4.38), 2.2 (1.46-3.3) for diabetic ketoacidosis; 0.29 (0.09-0.92), 16.5 (6.54-41.9), 0.18 (0.04-0.73) for rheumatoid arthritis in ≤65 age group. In > 65 age group, the RORs (95% CI) in patients using CTLA4 alone, PD1/PDL1 alone or the combination were 4.79 (3.49-6.58), 0.56 (0.4-0.78), 2.84 (2.06-4) for hypophysitis; 0.12 (0.06-0.24), 28.53 (18.5-44), 0.17 (0.1-0.29) for interstitial lung disease (ILD); 0.38 (0.19-0.78), 2.87 (2.01-4.1), 2.41 (1.64-3.54) for myocarditis. When we compared all the studied irAEs between age groups (≤65 and > 65) by ROR, the only statistically significant irAE was ILD. The RORs (95%CI) for ILD associated with PD1/PDL1 in age≤65 and > 65 were 11.3 (7.65-16.8) & 28.53 (18.49-44.02). Conclusions: There was no significant difference between irAEs in different age groups except with ILD, which is more commonly seen in the > 65 age group. The ROR combination irAE profiles provide hypothesis generating information regarding association between irAEs and the use of various immune therapies.

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Racial differences in development of immune-related adverse events.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e15148 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e15148-e15148 ◽

Cited By ~ 1

Author(s):

Shruti Bhandari ◽

Rohit Kumar ◽

Laura Nice ◽

Anmol Cheema ◽

Goetz H. Kloecker

Keyword(s):

African Americans ◽

Adverse Events ◽

Autoimmune Diseases ◽

Racial Differences ◽

Checkpoint Inhibitors ◽

Single Agent ◽

Retrospective Chart Review ◽

Cancer Type ◽

Immune System Activation ◽

Grade 3

e15148 Background: Immune-related adverse events (irAEs) due to immune checkpoint inhibitors (ICIs) are caused by non-specific immune system activation and develop in 30-70% of patients. The goal of this study is to examine the association of race with the development of irAEs secondary to ICIs as autoimmune diseases generally exhibit racial differences. Methods: A retrospective chart review was done using University of Louisville pharmacy database. Patients with solid cancers who received ICIs between Jan 2016 to June 2019 were included. IrAEs were identified through the review of electronic medical records. Descriptive analysis evaluated the incidence and severity of irAEs. Multivariable logistic regression was used to calculate standardized incidence of irAEs among Whites and African Americans. Results: A total of 476 patients were included in this study. The mean age was 61 years, 57% were males and 89.7% were whites. A majority of patients had melanoma (50%). The remainder of the dataset included lung (33.4%), gastrointestinal (7.4%), head & neck (4.8%), breast (2.5%) and genitourinary (1.9%) cancers. ICIs included single agent anti-PD-1 (74.8%), single agent anti-PD-L1 (9.4%), combination anti-CTLA-4 with anti-PD-1 (7.1%). Some patients were also treated with > 1 ICI as subsequent therapy (8.6%). Overall, the rate of irAEs was 44.3% with 33.8% grade 1-2 and 12.4% grade 3-4 irAEs. There was no difference in development of any grade irAEs in Whites as compared to African Americans after adjusting for age, sex, cancer type and ICIs (44.3% vs 44.2%; OR: 0.99, 95% CI: 0.50 – 1.97; p = 0.99). There was also no difference in development of grade 3-4 irAEs in whites as compared to African Americans (12.8% vs 14.5%; OR: 1.16, 95% CI: 0.43 – 3.12; p = 0.75). Conclusions: In this study, we found no racial difference in the development of irAEs between Whites and African Americans. This is in contrast to general autoimmune diseases which exhibit racial differences with higher prevalence among African Americans compared to Whites. We will continue to accrue patients to this study as larger sample size is needed to confirm these findings.

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