Immunotherapy before liver transplant in unresectable hepatocellular carcinoma: a case report.

Background: Hepatocellular carcinoma (HCC) is a leading cause of global cancer mortality, with liver transplantation as the sole curative treatment. For advanced disease, first-line systemic therapies including immune checkpoint inhibitors (ICIs) have shown a survival benefit, but there is scarce data on clinical outcomes when used prior to transplantation. Case Description: We present three case studies of patients who received immunotherapy with atezolizumab/bevacizumab or ipilimumab/nivolumab before liver transplant. We reviewed clinical outcomes including disease response, adverse events related to systemic therapy, as well as graft function post-operatively. One case demonstrated a 45% reduction in total HCC tumour burden whereas another showed stable disease with ICIs. No adverse clinical outcomes such as graft rejection or poor wound healing were noted post-transplant. Indeed, all three patients were successfully transplanted with excellent graft function at the last follow-up. Conclusions: Our observations and data suggest ICIs are a viable option for treatment in the pre-transplant setting. It does not routinely lead to fatal graft rejection and may lengthen eligibility times until a donor organ is available.

A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab.

The reduced cost of trastuzumab biosimilars has led to increased adoption for HER2-positive breast cancer. This review of trastuzumab biosimilars encompasses this development and real world clinical data in early breast cancer. In addition, we present a retrospective study evaluating the total pathological complete response (tpCR) rates (lack of residual invasive cancer in resected breast tissue and axillary nodes), of MYL-1401O to reference trastuzumab (TRZ) in the neoadjuvant setting for HER2+ early breast cancer (EBC) in Alberta, Canada. Neoadjuvant patients with HER2+ EBC treated with TRZ from November 2018-October 2019 and MYL-1401O from December 2019-September 2020 were identified. Logistic regression was used to control for variables potentially associated with tpCR: trastuzumab product, age, pre-operative T- and N-stage, grade, hormone receptor (HR)-status, HER2-status, chemotherapy regimen, and chemotherapy completion. tpCR was 35.6% in the MYL-1401O group (n = 59) and 40.3% in the TRZ (n = 77) group, p = 0.598. After controlling for clinically relevant variables, there was no significant difference in the odds of achieving tpCR in patients treated with TRZ versus MYL-1401O (OR 1.1, 95% CI 0.5-2.4, p = 0.850). tpCR rates were similar for patients treated with MYL-1401O compared to trastuzumab in our real world study of HER2+ neoadjuvant EBC and comparable to pivotal phase 3 trials.

Present and Emerging Biomarkers in Immunotherapy for Metastatic Non-Small Cell Lung Cancer: A Review.

Targeting the immune system, especially the PDL-1/PD-1 axis, has significantly improved the outcomes of metastatic lung cancer patients. However, only a portion of patients will benefit significantly from PD(L)1 therapeutics alone or in combination with either chemotherapy or anti-CTLA4 antibody. It is therefore important to study predictive biomarkers to help select the patients who will experience the most benefit from immunotherapy. In this paper, the current status of PDL-1 expression on tumour cells, the smoking status of patients, tumour mutational burden, gut microbiome and STK11 and KEAP1 mutations in the tumour as predictive biomarkers for PD(L)-1-based immunotherapy are summarized.