Adding ilixadencel to treatment with sunitinib does not appear to improve outcomes in patients with metastatic renal cell carcinoma (mRCC) undergoing nephrectomy, according to phase 2 data presented at IKCS North America 2022.
Response and survival outcomes were not significantly different between patients who received sunitinib monotherapy and those who received sunitinib in combination with ilixadencel, an allogeneic monocyte-derived dendritic cell immune primer.
The phase 2 trial (ClinicalTrials.gov Identifier: NCT02432846) included 88 patients with mRCC. They were randomly assigned to receive ilixadencel plus sunitinib (n=58) or sunitinib alone (n=30).
In the ilixadencel-sunitinib arm, 2 doses of ilixadencel were delivered intratumorally 2 weeks apart. This was followed by nephrectomy and sunitinib. In the sunitinib arm, patients underwent nephrectomy followed by sunitinib monotherapy.
Overall survival (OS) was the primary endpoint. The secondary endpoint was objective response rate (ORR), assessed up to 18 months post-enrollment.
There was no significant difference between the ilixadencel-sunitinib arm and the sunitinib arm for OS. The median OS was 35.6 months and 25.3 months, respectively (hazard ratio, 0.73; 95% CI, 0.42-1.27). The 18-month OS rate was 63% and 66%, respectively.
There was no significant difference in ORR between the treatment arms either. The ORR was 42.2% in the ilixadencel-sunitinib arm and 24.0% in the sunitinib arm (P = .13). Initially, of the 19 responses in the ilixadencel arm, 3 were complete responses (CRs). None of the responses in the sunitinib monotherapy arm were CRs.
At the final imaging follow-up at 18 months, 2 additional patients in the ilixadencel-sunitinib arm and 1 patient in the sunitinib arm had achieved a CR. The 5 patients who achieved a CR with ilixadencel and sunitinib remained alive at the latest survival follow-up, but the patient who achieved a CR with sunitinib monotherapy had died.
“Intratumoral vaccination with ilixadencel combined with sunitinib had a numerically higher response rate, including longstanding CRs, suggesting an immunologic effect of the experimental treatment,” the researchers concluded.
Disclosures: This trial was sponsored by Mendus in collaboration with TFS Trial Form Support and Accelovance. The study authors did not provide disclosures.
Ljungberg B, Karlsson-Parra A, Lindskog M. A randomized phase 2 study with a cell-based immune primer plus sunitinib versus sunitinib alone in metastatic renal cell carcinoma. Presented at IKCS North America 2022. November 4-5, 2022. Abstract 37.