Understanding the tolerability and toxicity profile of nivolumab in a Black population with lung cancer.

Abstract

e13788 Background: Lung cancer is one of the most common cancers. It is more common in the black population and black males have the highest mortality rate. With the emergence of new data, immunotherapy is becoming the standard of care for lung cancers. Nivolumab, a PDL-1 inhibitor is being used for NSCLC and metastatic squamous cell ca. However, data on the toxicity profile of the drug among the black population is currently lacking due to under representation in trials. This study therefore aims to understand the safety and toxicity profile of Nivolumab among black population with advanced lung cancer. Methods: An IRB approved retrospective chart review study was conducted. The study population consisted of 32 self-identified Black individuals diagnosed with advanced lung cancer ( small/non-small cell cancer) stage III and IV who received Nivolumab at a large safety net hospital between 2018-2023. Charts were reviewed to study: Development of known AEs, any grade. Tolerability of the drug- assessed as the lack of severe toxicities resulting in discontinuation of the drug. Appearance of any peculiar AEs not previously known. AEs warranting the use of healthcare resources, like ED visits and hospital admissions for specific AEs. The CTCAE v-5 was used to grade the AEs. The results were compared to the Checkmate trials to understand the difference in the toxicity of the drug among the black population. Results: 34% (n = 11) developed immune mediated AEs of the drug-any grade. 6.25%(n = 3) developed grade 3 and higher AE.15% (n = 5) developed severe AEs leading to discontinuation of therapy.19%(n = 6) were able to tolerate completion of therapy even with AEs. 19% ( n = 6) required ED visits/ hospitalizations due to immunotherapy adverse effects. AEs leading to discontinuation of therapy-were pneumonitis, immune mediated colitis and immune mediated encephalopathy. Incidence of common adverse effect in black population is tabulated in table 1 Incidence of any specific adverse effects previously not reported-0%. Conclusions: One third of the population developed immune mediated toxicities from Nivolumab, however only half of them were severe enough to result in discontinuation of therapy suggesting Nivolumab has good tolerability in the black population even in advanced lung cancers. Most immune mediated AEs were comparable to the results of the checkmate trials, pneumonitis and colitis were 3 times more common in the black population. Providers should therefore remain more watchful for these toxicities in black individuals receiving Nivolumab. Adverse effect Study population result Checkmate trials result Thyroid disorders 12.5% 10.8% Pneumonitis 9% 3.1% Severe rash,DRESS 3% 9% Colitis 6.25% 2.9% Immune mediated hepatitis 0% 1.8% Pancreatitis 0% <1% Hypophysitis 0% 0.6% Adrenal insufficiency 0% 1% Pericarditis 0% <1% Myocarditis 0% <1% Immune mediated nephritis 0% 1.2% Encephalitis 3% <1% Meningitis 0% <1%