Background: Checkpoint inhibition immunotherapy is standard of care treatment for BRAF wild type (wt) advanced/metastatic melanoma. 5-year analysis of KEYNOTE-006 demonstrated Pembrolizumab was superior to Ipilimumab for median progression free survival (mPFS) (8.4mo v 3.4mo) and median overall survival (mOS) (32.7mo v 15.9mo) with 4-year survival 42.3%. Grade 3+ toxicity rate was 17%. First line Nivolumab + Ipilimumab in CHECKMATE-067 showed mPFS 11.5mo and mOS not reached (95% CI 38.2 - NR). The 4-year survival rate was 53%. Grade 3+ toxicity was 59%.
Aim: Determine the survival outcomes and safety of first line Pembrolizumab and Nivolumab + Ipilimumab for advanced melanoma in a regional cancer centre.
Methods: Retrospective analysis of all patients with advanced BRAF wt melanoma who received immunotherapy between May 2015 – May 2019 at Liz Plummer Cancer Centre.
Results: 56 patients were treated during the study period. The majority were male (68%) and good performance status; ECOG 0-1 (87%). Poor prognostic features included: ECOG 3+ (6%), brain metastases (16%), ≥ 3 sites of metastases (43%), and raised LDH (50%). Of 9 patients with brain metastases, 7 (78%) also received local treatment (surgery and/or radiotherapy).
Pembrolizumab monotherapy (88%) was utilised more than Nivolumab + Ipilimumab (13%).
The clinical response rate was 55%, including 19 (34%) complete responses.
The estimated mPFS was 9.0mo (95% CI 9.0mo-NR) and mOS was not reached (95% CI 31.2mo–NR).
Grade 3+ toxicity rate was 14 (25%) and was higher for Nivolumab + Ipilimumab (71%) than Pembrolizumab (18%). There were no treatment-related deaths.
Conclusion: In our real-world population with advanced BRAF wild type melanoma, the clinical response rate to first line immunotherapy was 55% and the safety profile was in keeping with clinical trials. The data for long term survival is not yet mature and will be assessed in a follow up audit.