1848P - Safety and efficacy of immune checkpoint inhibitors in patients with cancer and hepatitis B: Multicentre experience

Background

Patients with chronic viral hepatitis have been excluded from clinical trials despite lack of robust evidence of viral reactivation with immune checkpoint inhibitor (ICI) use. This study aimed to examine the outcomes of patients with chronic hepatitis B who received ICI.

Methods

We reviewed the charts of patients who received an ICI between 2016 and 2023 at three major cancer centres in Türkiye.

Results

Of the 1352 patients, we identified 65 (4.8%) patients with HbsAg+ and others were HbsAg (-). 47 were male (72.3%). 42 patients (64.6%) were on anti-viral treatment. The most common diagnoses were hepatocellular carcinoma (HCC) (23.1%), non-small cell lung cancer (NSCLC) (24.6%) and renal cell cancer (10.8%). Except for one patient (1.5%), all patients were able to receive ICI treatment without hepatitis B reactivation. The patient with reactivation had HCC and had normal HBV-DNA at baseline and also during treatment. However, HBV viral load increased 9 months after the discontinuation of ICI. Unfortunately, he had complied very poorly with his antiviral treatment. The oncological outcomes of patients with NSCLC and HCC were also evaluated. Of the 15 patients with HCC, 3 (20%) had a partial response, while 2 ( 13%) had stable disease. The median progression-free survival (PFS) of HCC was 4.9 months (95% confidence interval (CI) 1.1-8.8), while the median overall survival (OS) was 11.8 months (95% CI 4.7-18.9). Among the 16 patients with NSCLC, 4 (25%) had a partial response, and 6 (37%) had stable disease. The median PFS was 5.8 months (95% CI 3.0-8.7), and the median OS was 36.7 months (95% CI 2.8-70.6) for these patients. Of the 65 patients, 8 (12.3%) experienced immune-related adverse events of any grade, with 1 (1.5%) having grade 3. One patient had grade 3 pneumonitis with nivolumab. After steroid use and taper, he could even be successfully re-challanged with nivolumab. He had stable disease with this treatment.

Conclusions

ICIs appear to be safe and effective in patients with chronic hepatitis B. Even if hepatitis viral load is negative, it may be appropriate to give anti-viral prophylaxis to HbsAg+ patients. We believe that these patients should not be deprived of the possible benefits of ICIs solely on the basis of HbsAg positivity.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.