Pegilodecakin Plus Anti-PD-1 Agents May Be Effective in Metastatic Renal Cell Carcinoma
Researchers assigned 38 patients with metastatic renal cell carcinoma to receive pegilodecakin plus nivolumab or pembrolizumab.
|The following article features coverage from the American Society of Clinical Oncology (ASCO) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
The addition of pegilodecakin to nivolumab or pembrolizumab may be an effective and well-tolerated treatment option among patients with metastatic renal cell carcinoma (mRCC), according to an oral presentation that will be given at the American Society of Clinical Oncology 2018 Annual Meeting.1
Previous studies have demonstrated that pegilodecakin, a pegylated human interleukin-10 that stimulates the cytotoxicity and proliferation of CD8+ T-cells, produces a partial response rate of 25% among patients with heavily pretreated mRCC.
In this non-randomized phase 1b study (ClinicalTrials.gov Identifier: NCT02009449), researchers assigned 38 patients with mRCC to receive pegilodecakin 10 or 20 µg/kg plus nivolumab 3 mg/kg or pembrolizumab 2 mg/kg. Study participants had a median of 1 previous treatment, including at least 1 vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).
At the time of analysis there were 34 evaluable patients. After a median follow-up of 13.8 months, median progression-free survival (PFS) was 16.7 months among patients who received pegilodecakin plus nivolumab and PFS was not evaluable among patients who received pembrolizumab and pegilodecakin. The 1-year overall survival (OS) rate was 89% overall.
Fourteen (41%) and 3 (9%) patients achieved partial response and complete response, respectively. Fifteen patients (44%) had stable disease, and a tumor reduction exceeding 30% was reported in 8 of these patients. Pegilodecakin had a large effect in increasing T-cell clones in the blood, which correlated with tumor response.
Grade 3 to 4 adverse effects among patients treated with pegilodecakin 20 µg/kg included anemia, thrombocytopenia, hypertriglyceridemia, reversible cytokine release syndrome with splenomegaly, and increased immune-mediated red blood cell phagocytosis. Patients who received a lower dose of 10 µg/kg did not report grade 3 to 4 anemia or thrombocytopenia.
The authors concluded that “pegilodecakin with nivolumab or pembrolizumab is well-tolerated in mRCC patients; the recommended phase 2 dose is 10 ug/kg. The efficacy and the observed CD8+ T cell activation are very encouraging.”
Read more of Cancer Therapy Advisor's coverage of the American Society of Clinical Oncology (ASCO) 2018 meeting by visiting the conference page.
- Tannir NM, Naing A, Infante JR, et al. Pegilodecakin with nivolumab (nivo) or pembrolizumab (pembro) in patients (pts) with metastatic renal cell carcinoma (RCC). Oral presentation at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.