In a study presented by Lindskog et al at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium (Abstract 11), researchers found ilixadencel, a cell-based allogeneic off-the-shelf product, in combination with sunitinib produced a higher objective response rate than sunitinib alone in patients with newly diagnosed synchronous metastatic renal cell carcinoma.
MERECA Trial
The randomized phase II MERECA trial evaluated prenephrectomy intratumoral injection of ilixadencel—the agent primes anticancer immune response when injected intratumorally—followed by postnephrectomy sunitinib vs postnephrectomy sunitinib monotherapy. From 2014 to 2017, 88 patients were randomly assigned 2:1 to ilixadencel/sunitinib or sunitinib alone.
In the ilixadencel/sunitinib arm, 2 patients did not receive ilixadencel, 10 did not receive sunitinib, and 1 did not have any follow-up computed tomography scan. Five patients in the sunitinib arm never received sunitinib.
Overall survival was assessed from time of enrollment; progression-free survival and tumor response was assessed from start of treatment with sunitinib.
KEY POINTS
- Five patients (11%) treated with ilixadencel/sunitinib had a complete response vs one patient (4%) treated with sunitinib monotherapy.
- Confirmed objective response rate was 42.2% in the combination group vs 24.0% in the monotherapy group.
Results
Five patients (11%) treated with ilixadencel/sunitinib had a complete response vs one patient (4%) treated with sunitinib monotherapy. Confirmed objective response rate was 42.2% in the combination group vs 24.0% in the monotherapy group. Median duration of response (from start of sunitinib) was 7.1 vs 2.9 months; progression-free survival (also from start of sunitinib) was 11.8 vs 11.0 months. Median overall survival has not been reached in either group. Adding ilixadencel to sunitinib did not increase the amount of grade 3 and 4 adverse events.
The study authors concluded, “Compared to sunitinib monotherapy, combined treatment with ilixadencel followed by sunitinib demonstrated higher confirmed objective response rate, including several complete responses and longer duration of response, in patients with newly diagnosed synchronous metastatic renal cell carcinoma.”
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
