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Modeling Spontaneous Metastatic Renal Cell Carcinoma mRCC in Mice Following Nephrectomy
Published on: April 29, 2014
Clinical activity of nivolumab in patients with non-clear cell renal cell carcinoma
Vadim S Koshkin1, Pedro C Barata1, Tian Zhang2
1Department of Hematology & Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, 9500 Euclid Ave, Desk CA60, Cleveland, OH, 44195, USA.
Background:
Nivolumab is approved for patients with metastatic renal cell carcinoma (mRCC) refractory to prior antiangiogenic therapy. The clinical activity of nivolumab in patients with non-clear cell RCC subtypes remains unknown as these patients were excluded from the original nivolumab trials.
Methods:
Patients from 6 centers in the United States who received at least one dose of nivolumab for non-clear cell mRCC between 12/2015 and 06/2017 were identified. A retrospective analysis including patient characteristics, objective response rate according to RECIST v1.1 and treatment-related adverse events (TRAEs) was undertaken.
Results:
Forty-one patients were identified. Median age was 58 years (33-82), 71% were male, and majority had ECOG PS 0 (40%) or 1 (47%). Histology included 16 papillary, 14 unclassified, 5 chromophobe, 4 collecting duct, 1 Xp11 translocation and 1 MTSCC (mucinous tubular and spindle cell carcinoma). Among 35 patients who were evaluable for best response, 7 (20%) had PR and 10 (29%) had SD. Responses were observed in unclassified, papillary and collecting duct subtypes. In the entire cohort, median follow-up was 8.5 months and median treatment duration was 3.0 months. Median PFS was 3.5 months and median OS was not reached. Among responders, median time to best response was 5.1 months, and median duration of response was not reached as only 2 out of 7 responders had disease progression during follow-up. TRAEs of any grade were noted in 37% and most commonly included fatigue (12%), fever (10%) and rash (10%). Nivolumab treatments were postponed in 34% and discontinued in 15% of patients due to intolerance. No treatment-related deaths were observed.
Conclusions:
Nivolumab monotherapy demonstrated objective responses and was well tolerated in a heterogeneous population of patients with non-clear cell mRCC. In the absence of other data in this treatment setting, this study lends support to the use of nivolumab for patients with metastatic non-clear cell renal cell carcinoma.
Insights
Nivolumab showed objective responses in patients with non-clear cell metastatic renal cell carcinoma (mRCC). This immunotherapy was well tolerated, supporting its use in this patient population.
Area of Science:
- Oncology
- Immunotherapy
- Renal Cell Carcinoma Research
Background:
- Nivolumab is approved for metastatic renal cell carcinoma (mRCC) refractory to antiangiogenic therapy.
- Clinical activity in non-clear cell RCC subtypes is unknown due to trial exclusions.
Purpose of the Study:
- To evaluate nivolumab's efficacy and safety in non-clear cell mRCC.
- To assess objective response rates and treatment-related adverse events.
Main Methods:
- Retrospective analysis of 41 patients with non-clear cell mRCC treated with nivolumab.
- Data collected on patient characteristics, objective response rate (RECIST v1.1), and treatment-related adverse events (TRAEs).
Main Results:
- Objective responses (PR/SD) observed in 20% and 29% of evaluable patients, respectively.
- Responses seen in papillary, unclassified, and collecting duct subtypes.
- Median progression-free survival (PFS) was 3.5 months; overall survival (OS) not reached. Nivolumab was generally well tolerated.
Conclusions:
- Nivolumab monotherapy demonstrated objective responses and was well tolerated in non-clear cell mRCC.
- Supports nivolumab use in metastatic non-clear cell renal cell carcinoma where other data is limited.
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