Disparities and outcomes of immune checkpoint inhibitor therapies in LMICs: Retrospective study on current state, efficacy, and challenges in Armenia.
Authors: Sargsyan Amalya , Zohrabyan Davit , Safaryan Liana , Mailyan Mariam , Harutyunyan Martin , Tamamyan Gevorg , Soghomonyan Karine Haykaz , Sargsyan Mariam , Harutyunyan Lilit , Avagyan Armen , Janoyan Naira , Baloyan Elen , Hovsepyan Shushan , Tadevosyan Anna , Karapetyan Nune , Rushanyan Marine , Mkrtchyan Gohar , Geokchyan-Kzhdryan Haykuhi , Araqelyan Varduhi , Bardakhchyan Samvel 
Published: June 2024

e23315 Background: The escalating incidence of cancer in Armenia is a global trend, underscoring the urgency for innovative treatments, including immune checkpoint inhibitors (ICIs). This study, a first in the region, investigates ICIs' real-world impact, emphasizing the current state and critical gaps in access to care. Methods: We conducted a retrospective review of 224 patients, excluding 32, resulting in 192 patients treated with ICIs between 2017 and 2023 across four major oncology centres. The review covered demographic and clinical data, genetic testing, treatment regimens, and survival outcomes, analyzed using the STATA 18 BE. Results: The mean age of the patients was 61.4 years, with 69.27% being male. Lung cancer was the most common diagnosis (42.19%, n = 81), followed by melanoma (11.98%, n = 23) and gastric cancer (10.94%, n = 21). Survival outcomes varied, with melanoma patients exhibiting a mean overall survival (OS) of 33.26 months, lung cancer patients 19.69 months, and gastric cancer patients 20.50 months; the survival difference between patients with metastases and without was not statistically significant. Patients receiving ICIs in the second or later lines of treatment had a 2.12-fold lower chance of survival compared to those receiving them as first-line treatment (95% CI 1.16-3.88, p = 0.014). 78% of patients received ICIs in the metastatic setting and only 22% in curative. In two centres, among 185 patients with metastatic lung cancer, only 23.2% (43 patients) received ICIs, and of these, about 50% underwent mutation testing, with only 4 assessed via broad panel NGS. A significant 76.8% (142 patients) did not receive immunotherapy. Furthermore, 34% of those starting ICI treatment were forced to discontinue due to financial hardships. Pembrolizumab and Nivolumab were the most widely used agents, but the choice varies significantly between centres. Conclusions: The financial barrier is substantial: the cost of one pembro cycle on the black market, at $3,000, is 3.8 times the annual income of those at the national poverty line, more than twice the income of the lower middle-income class, and represents over 60% of the country's GDP per capita. Median cycle lengths for ICIs, such as 6.5 for Ipil+Nivo and 5.61 for Pembro, are below the NCCN's standard recommendations, highlighting the profound impact of financial constraints on treatment adherence and duration. This study reveals the stark reality of ICI accessibility and affordability in Armenia, where a significant portion of cancer patients are unable to benefit from these potentially life-extending treatments. Additionally, a preference bias towards selecting treatments without nationwide guidelines was observed, alongside the absence of a national E-health database, underscoring the need for policymaker attention, insurance adjustments, and more precise, prospective data collection.