Dirk Schadendorf, MD of University Hospital Essen, Essen, Germany discusses the results of the efficacy and quality of life outcomes in patients with advanced melanoma who discontinued nivolumab plus ipilimumab treatment due to toxicity in the Phase III CheckMate 067 and 069 trials (NCT01844505 and NCT01927419). Prof. Schadendorf presented a pooled analysis of over 400 patients, analyzing patients who had to discontinue treatment because of toxicity at the 2016 World Congress on Cancers of the Skin (WCCS) and the Congress of the European Association of Dermato-Oncology (EADO) in Vienna, Austria. 50% of patients on the combination of nivolumab plus ipilimumab experienced grade 3 or 4 events and 38% of patients discontinued treatment within the first 8-12 weeks. The question is whether patients who discontinued treatment due to toxicity, also experienced a clinical benefit in comparison to patients who continued with the treatment. The results show that patients who discontinued, had an equally good or even better progression-free survival (PFS) as patients who continued treatment; response rate also seem to be almost 15% higher. Patients who experienced toxicity seem to be more sensitive to checkpoint blockade. According to Prof. Schadendorf, the clinical implications of these findings are not clear; for example, it is not clear if the results imply that only 12 weeks of treatment are required. Another interpretation of the results is that patients who are particulary immunosensitive are selected and this early autoimmunity in some patients is a biomarker for good responsiveness while patients who are not as sensitive, need to be treated for longer.