- Addition of intratumoral ilixadencel to sunitinib improved responses in patients with newly diagnosed synchronous metastatic renal cell carcinoma (RCC).
Why this matters
- Ilixadencel is an off-the-shelf dendritic cell-based primer, designed to elicit an anticancer immune response when injected intratumorally.
- This phase 2 study investigated its potential as first-line systemic therapy for newly diagnosed synchronous metastatic RCC.
- Phase 2 MERECA trial evaluated patients who were randomly assigned to receive either intratumoral ilixadencel pre-nephrectomy followed by sunitinib post-nephrectomy (n=45) or sunitinib monotherapy post-nephrectomy (n=25).
- Funding: Immunicum AB.
- The complete response rate was 11% with ilixadencel plus sunitinib and 4% with sunitinib monotherapy.
- The confirmed overall response rate was 42.2% in patients treated with ilixadencel plus sunitinib and 24.0% in patients treated with sunitinib monotherapy.
- The median duration of response for the ilixadencel plus sunitinib group and the sunitinib monotherapy group was 7.1 and 2.9 months, respectively.
- The median progression-free survival for the ilixadencel plus sunitinib group and the sunitinib monotherapy group was 11.8 and 11.0 months, respectively.
- Ilixadencel did not add any treatment-related grade 3-4 adverse events or serious adverse events; pyrexia was the most common adverse event related to ilixadencel treatment.
- Small sample size.
- Short follow-up duration.
Dr Magnus Lindskog, MD, PhD, from the Uppsala University Hospital, Sweden commented: "The observed activity of ilixadencel appears to be driven by responses in patients with intermediate risk."