Current studies have shown that second line Nivolumab, a PD1-inhibitor monoclonal antibody, has improved outcomes in stage IV NSCLC patients. It is available on compassionate access for second line therapy in metastatic NSCLC, while it is PBS subsidised in Melanoma. We look at our experience with Nivolumab at the Alan Walker Cancer Care Centre in the Northern Territory.
Patients with metastatic NSCLC on second line Nivolumab were recruited between November 2015 to June 2016 and were observed for tumour regression measured by RECIST radiological criteria on a staging scan performed on average 8 weeks after commencement of Nivolumab, adverse effects and survival.
12 patients received Nivolumab; 11 consented, 9(82%) were male and 1 was of indigenous background. Their ages ranged from 45 to 78(Median age 68). 9(82%) had adenocarcinoma and 2(18%) were EGFR mutant. 2(18%) were heavily pre-treated with 3 lines of therapy prior to Nivolumab. Out of the 11 patients, 1 patient showed partial regression, 6 showed stable disease and 4 progressed according to RECIST criteria. Overall response rate was 9%. Only 2 patients are on ongoing therapy. 1 EGFR-mutant patient progressed on Nivolumab. 7(64%) patients experienced adverse effects, 4(57%) of which had treatment ceased due to immune-related toxicity (2 had Grade 3 pneumonitis, 1 had colitis, 1 had an infusion reaction). All toxicities were reversible with steroid administration. 5 patients died from progressive disease, making survival a mean of 22 weeks from commencement of Nivolumab. 2 months survival was 27%. Further information on survival will be published once mature data is available.
Our study population was small and response to therapy was unpredictable. We noticed a higher number of toxicities compared to published data, however all toxicities were reversible with prompt usage of systemic steroids. Prognostic and predictive biomarkers markers would be helpful in selecting patients to optimise response and avoid toxicity.