- 13% of patients with advanced renal cell carcinoma (aRCC) treated beyond progression (TBP) with nivolumab (Opdivo) experiencing ≥30% further decrease in tumor burden.
- Tumor burden reduction was observed in patients who initially responded and then progressed, and patients with stable disease or progressive disease as best overall response.
- Acceptable safety profile was maintained.
Why this matters
- In November 2015, nivolumab became the first immune checkpoint inhibitor approved for aRCC.
- Immunotherapies are associated with tumor flare, with increased tumor burden or new lesions preceding clinical responses.
- This may be mistaken for disease progression and lead to discontinuation.
- 316 patients with aRCC who progressed on nivolumab were included.
- Funding: Bristol-Myers Squibb and Ono Pharmaceutical Co. Ltd.
- 153 were TBP patients, of which 20 patients showed ≥30% tumor burden reduction.
- ≥30% tumor burden reduction was seen in 28% patients with complete or partial response, 6% with stable disease, and 14% with progressive disease as their best response before first progression.
- 83% patients in TBP and 73% in non-TBP group experienced treatment-related adverse event.
- Rationale for TBP was not assessed.
- Favorable disease characteristics of patients TBP may have overestimated the TBP benefit.