Advanced RCC: nivolumab shows benefit even after progression

Access to the full content of this site is available only to registered healthcare professionals. Register to read more
  • 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.

Study design

  • 316 patients with aRCC who progressed on nivolumab were included.
  • Funding: Bristol-Myers Squibb and Ono Pharmaceutical Co. Ltd.

Key results

  • 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.