437 Safety and efficacy of immune checkpoint inhibitors (ICI) in patients living with HIV (PLWH) and metastatic non-small cell lung cancer (NSCLC): a matched cohort study from the international CATCH-IT consortium

Nassar, Amin H.; Adib, Elio; Fitzgerald, Bailey; Huang, Jiaming; Mouhieddine, Tarek H.; Nonato, Taylor; McKay, Rana R.; Li, Mingjia; Mittra, Arjun; Owen, Dwight H.; Lorentsen, Michael; Dittus, Christopher; Dizman, Nazlı; Emu, Brinda; Falohun, Adewunmi; Abdel-Wahab, Noha; Bankapur, Anand; Reed, Alexandra S.; Dobbs, Ryan W.; Kim, Chul; Arora, Aakriti; Shah, Neil P.; El-Am, Edward; Kozaily, Elie; Abdallah, Wassim; Al‐Hader, Ahmad; Ghazal, Batool Abu; Saeed, Anwaar; Drolen, Claire; Lechner, Melissa G.; Espinar, Javier; Nebhan, Caroline A.; Johnson, Douglas H.; Haykal, Tarek; Morse, Michael A.; Cortellini, Alessio; Pinato, David J.; Pria, Alessia Dalla; Bower, Mark; Hall, E. D.; Bakalov, Veli; Bahary, Nathan; Rajkumar, Aarthi; Mangla, Ankit; Shah, Vishal; Singh, Rajesh; Nana, Frank Aboubakar; Lia, Nerea Lopetegui; Dima, Danai; Funchain, Pauline; Saleem, Rabia; Woodford, Rachel; AO, Georgina Long; Menzies, Alexander M.; Genova, Carlo; Barletta, Giulia; Puri, Sonam; Florou, Vaia; Idossa, Damé; Queirolo, Paola; Addeo, Alfredo; Bersanelli, Melissa; Freeman, Dory; Xie, Wanling; Ramaswami, Ramya; Marron, Thomas U.; Choueiri, Toni K.; Lurain, Kathryn; Baden, Lindsey R.; Sonpavde, Guru; Naqash, Abdul Rafeh

doi:10.1136/jitc-2022-sitc2022.0437

Cited by 2 publications

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“…A few retrospective studies have shown similar ICI efficacy and toxicity in patients with underlying AIDs vs. no AIDs [ 27 , 28 , 29 , 30 ]. In addition, retrospective studies of patients with CVI, including HIV, HBV, and HCV, have shown similar ICI efficacy and safety compared to patients without CVI [ 31 , 32 , 33 ].…”

Section: Introductionmentioning

confidence: 99%

Clinical Outcomes of Immune Checkpoint Inhibitors in Unique Cohorts Underrepresented in Clinical Trials

Shah,

Della Pia,

et al. 2024

Cancers

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Regulatory approval of immune checkpoint inhibitors (ICIs) was based on results of large, randomized clinical trials, resulting in limited outcomes data in patient cohorts typically underrepresented in such trials. The objective of this study was to evaluate the efficacy and safety of ICIs in these unique patient cohorts. This is a multicenter, retrospective analysis of real-world data at six academic and community clinics in the United States from 1 January 2011 to 1 April 2018. Patients were included if they had received at least one cycle of ICI treatment. Unique patient cohorts included age > 75 years, non-White race, positive smoking history, ECOG performance status (PS) ≥ 2, BMI ≥ 30 kg/m2, autoimmune diseases (AIDs), chronic viral infections (CVI), extensive prior lines of therapy (LOTs), or >three metastatic sites. Immune-related adverse events (irAEs), overall survival (OS), and time to treatment failure were evaluated in the entire cohort and in NSCLC patients treated with PD-(L)1 monotherapy. Outcomes and their association with unique patient cohorts were compared on univariate analysis and multivariate analysis to those without a particular characteristic in the entire NSCLC PD-(L)1 monotherapy cohorts. In total, 1453 patients were included: 56.5%—smokers, 30.4%—non-White, 22.8%—elderly, 20.8%—ECOG PS ≥ 2, 15.7%—history of AIDs, and 4.7%—history of CVI. The common ICIs were nivolumab (37.1%) and pembrolizumab (22.2%). Black patients, compared to White patients, experienced fewer irAEs (OR 0.54, p < 0.001). An ECOG PS of ≥2 (HR = 2.01, p < 0.001) and an increased number of previous LOTs were associated with poor OS (the median OS of 26.2 vs. 16.2 vs. 9.6 months for one vs. two vs. three prior LOTs, p < 0.001). The above results were confirmed in anti-PD-(L)1 monotherapy non-small cell lung cancer patients (n = 384). Overall, ICIs were safe and efficacious in these typically underrepresented patient cohorts. We noted ECOG PS ≥ 2 and an increased prior LOTs were associated with poor ICI efficacy, and Black patients, compared to White patients, experienced fewer irAEs.

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Section: Introductionmentioning

confidence: 99%

Clinical Outcomes of Immune Checkpoint Inhibitors in Unique Cohorts Underrepresented in Clinical Trials

Shah,

Della Pia,

et al. 2024

Cancers

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Safety and tolerability of immune checkpoint inhibitors in people with HIV infection and cancer: insights from the national prospective real-world OncoVIHAC ANRS CO24 cohort study

Assoumou,

Baldé,

Katlama

et al. 2024

J Immunother Cancer

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BackgroundImmune checkpoint inhibitors (ICIs) have been a major advance in cancer management. However, we still lack prospective real-world data regarding their usage in people with HIV infection (PWH).MethodsThe ANRS CO24 OncoVIHAC study (NCT03354936) is an ongoing prospective observational cohort study in France of PWH with cancer treated with ICI. We assessed the incidence of grade ≥3 immune-related adverse events (irAEs). All grade ≥3 irAEs were reviewed by an event review.ResultsBetween January 17, 2018, and December 05, 2023, 150 participants were recruited from 33 sites and 140 were included in this analysis. At the data cut-off date of December 05, 2023, the median follow-up was 9.2 months (IQR: 3.9–18.3), with a total of 126.2 person-years.Median age was 59 years (IQR: 54–64) and 111 (79.3%) were men. Median time since HIV diagnosis was 25 years (12–31), the median duration on antiretroviral (ARV) was 19.5 years (7.7–25.4), and the CD4 nadir was 117/µL (51–240). ICI regimens comprised anti-programmed cell death protein-1 (PD-1) for 111 (79.3%) participants, anti-programmed death-ligand 1 for 25 (17.9%), a combination of anti-PD-1 and anti-cytotoxic T-lymphocyte associated protein 4 for 3 (2.1%), and anti-PD-1 along with anti-vascular endothelial growth factor receptor for 1 (0.7%). The most frequent cancers were lung (n=65), head/neck (n=15), melanoma (n=12), liver (n=11) and Hodgkin’s lymphoma (n=9).During follow-up, a total of 34 grade ≥3 irAEs occurred in 20 participants, leading to an incidence rate of 26.9 per 100 person-years. The Kaplan-Meier estimates of the proportion of participants with at least one episode of grade ≥3 irAEs were 13.8% at 6 months, 15.0% at 12 months and 18.7% at 18 months. One treatment-related death due to myocarditis was reported (0.7%). Multivariable analysis of cumulative incidence showed that participants with time since HIV diagnosis >17 years (incidence rate ratio (IRR)=4.66, p=0.002), with CD4<200 cells/µL (IRR=4.39, p<0.0001), with positive cytomegalovirus (CMV) serology (IRR=2.76, p=0.034), with history of cancer surgery (IRR=3.44, p=0.001) had a higher risk of incidence of grade ≥3 irAEs.ConclusionThis study showed that the incidence of a first episode of grade ≥3 irAE was 15.0% (95% CI: 9.6% to 22.9%) at 1 year and the cumulative incidence of all severe irAE episodes was 26.9 per 100 person-years. Low CD4 count, positive CMV serology, history of cancer surgery and a longer time since HIV diagnosis were associated with the occurrence of severe irAEs.

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437 Safety and efficacy of immune checkpoint inhibitors (ICI) in patients living with HIV (PLWH) and metastatic non-small cell lung cancer (NSCLC): a matched cohort study from the international CATCH-IT consortium

Cited by 2 publications

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Clinical Outcomes of Immune Checkpoint Inhibitors in Unique Cohorts Underrepresented in Clinical Trials

Clinical Outcomes of Immune Checkpoint Inhibitors in Unique Cohorts Underrepresented in Clinical Trials

Safety and tolerability of immune checkpoint inhibitors in people with HIV infection and cancer: insights from the national prospective real-world OncoVIHAC ANRS CO24 cohort study

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