PROs Underpin Frontline Nivolumab–Ipilimumab Benefits For Advanced NSCLC

Author: By Lynda Williams, Senior medwireNews Reporter 

medwireNews: Patient-reported outcomes (PROs) add support for the first-line use of nivolumab plus ipilimumab with limited chemotherapy for patients with stage IV or recurrent non-small-cell lung cancer (NSCLC), say the CheckMate 9LA investigators. 

Speaking at the ESMO Virtual Congress 2020, Martin Reck, from LungClinic in Grosshansdorf, Germany, explained that the immunotherapy combination given with two cycles of chemotherapy was approved by the USA and other countries after achieving significantly improved overall survival and a tolerable safety profile compared with four cycles of chemotherapy. 

The Lung Cancer Symptom Scale (LCSS) average symptom burden index and 3-item global index showed that patients in both the immunotherapy and chemotherapy only trial arms experienced a “maintenance and improvement over time compared with baseline”, although neither group achieved the minimal important difference (MID) required to show a meaningful change, the presenter said. 

Similarly, changes from the beginning of treatment in overall health status, as measured by the EQ-5D-3L visual analogue scale showed a “continuous improvement” over time in both treatment arms that “approached” the MID threshold, Martin Reck commented, with the average overall score approaching the UK population norm for health status. 

Moreover, there was a “substantial delay” in the time to definitive deterioration during treatment and follow-up for patients given nivolumab plus ipilimumab and chemotherapy, with a significant hazard ratio of 0.66 versus chemotherapy alone, the investigator reported. 

Forest plot analysis showed that this delay in deterioration with the immunotherapy regimen occurred across the LCSS measures of anorexia, fatigue, cough, dyspnoea, haemoptysis and pain, as well as the global index measures of distress, interference with activity and health-related quality of life. 

“These PRO results, together with previously reported statistically significant and clinically meaningful improvements in efficacy with manageable safety, support the use of [nivolumab and ipilimumab plus chemotherapy] as first-line treatment for patients with NSCLC”, Martin Reck concluded.  

Reference  

Reck M, Ciuleanu T, Cobo M, et al. First-line nivolumab (NIVO) + ipilimumab (IPI) combined with 2 cycles of platinum-based chemotherapy (chemo) vs 4 cycles of chemo in advanced non-small cell lung cancer (NSCLC): Patient-reported outcomes (PROs) from CheckMate 9LA. Ann Oncol 2020; 31 (Suppl 4): S1142–S1215. DOI: 10.1016/annonc/annonc325.