Immunotherapy targeting the PD-1/PD-L1 axis has become a standard component of care across multiple tumor types, including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), and others. While these agents result in durable responses, there is limited data regarding long-term survival in these patients. In a secondary analysis of the phase I CA209-003 trial, 270 patients with advanced cancer who had received nivolumab treatment were followed for a minimum of 58.3 months to determine the long-term outcomes associated with nivolumab treatment. Patients with advanced melanoma, RCC, and NSCLC were included in this analysis, and 40% of patients had received 3 or more prior lines of systemic therapy.
The median overall survival (OS) was 20.3 months for patients with melanoma, 22.4 months for patients with RCC, and 9.9 months for patients with NSCLC. Estimated 5-year survival rates associated with nivolumab treatment was 34.2% in patients with melanoma, 27.7% in patients with RCC, and 15.6% in patients with NSCLC. Presence of liver or bone metastases were associated with a reduced likelihood of survival, while a performance status of 0 was associated with an increased chance of survival. Treatment-related adverse events (AEs) were associated with prolonged survival. Compared to patients who experienced no treatment-related adverse events (AEs), survival was significantly prolonged in patients who experienced any grade AEs (19.8 months vs 5.8 months; P < .001) or AEs of grade 3 or higher (20.3 months vs 5.8 months; P < .001).
The investigators concluded that nivolumab is associated with long-term survival in heavily pretreated patients with melanoma, RCC, and NSCLC, supporting the idea of this treatment as a “functional cure” for some patients. Furthermore, treatment-related AEs may serve as a biomarker of treatment efficacy, serving as a marker of those patients who are most likely to have prolonged survival. In an accompanying editorial, the authors agreed that these results support other data regarding the long-term survival benefit associated with immunotherapy and highlighted that efforts to identify characteristics associated with long-term survival, such as good performance status and development of treatment-related AEs, will be important to guide treatment decisions moving forward.
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