Some patients who have advanced renal cell carcinoma (RCC) and experience disease progression while on nivolumab therapy may continue to benefit from the drug beyond progression, according to a study.
Investigators found that 13% of patients who remained on nivolumab therapy after progression experienced a 30% or greater reduction in tumor burden. The study also demonstrated that continued therapy with nivolumab has an acceptable safety profile.
Bernard Escudier, MD, of Gustave Roussy in Villejuif, France, and colleagues studied a subset of patients in the CheckMate 025 trial. Patients continuing to tolerate therapy and exhibiting investigator-assessed clinical benefit were eligible to be treated beyond RECIST [Response Evaluation Criteria in Solid Tumors] progression (TBP) and received therapy for at least 4 weeks after first progression. Patients received nivolumab 3 mg/kg intravenously every 2 weeks.
Compared with the NTBP group, the TBP group had better Karnofsky performance status, less deterioration in Karnofsky performance status, shorter time to response, lower incidence of new bone lesions, and improved quality of life.
Of 406 nivolumab-treated patients, 316 (78%) progressed by RECIST criteria. Of those who progressed, 153 (48%) were TBP and 163 (52%) were not treated beyond progression (NTBP). Before being TBP, the objective response rate was 20% and 14% in TBP and NTBP patients, respectively. After first progression, the median duration of nivolumab was 3.4 months. Of patients TBP, 48% (74/153) had any tumor burden reduction and 13% (20/153) had a 30% or greater tumor burden reduction after first progression, the researchers reported online ahead of print in European Urology.
From 4 weeks post-progression, median overall survival (OS) was longer in the TBP than the NTBP group (20.4 vs 12.2 months). Median OS from randomization also was longer in the TBP group (28.1 vs 15.3 months).
The incidence of treatment-related adverse events in TBP patients was lower after compared with before progression (59% vs 71%).
Of the 153 patients TBP, 31 experienced a complete or partial response, 51 had stable disease, and 70 had progressive disease as best overall response from randomization to first progression. One patient did not have an on-study assessment.
Escudier B, Motzer RJ, Sharma P, et al. Treatment beyond progression in patients with advanced renal cell carcinoma treated with nivolumab in CheckMate 025. Eur Urol 2017; published online ahead of print on April 12. doi: 10.1016/j.eururo.2017.03.037