The combination of ilixadencel plus sunitinib has demonstrated favorable survival compared with sunitinib alone in patients with newly diagnosed metastatic synchronous renal cell carcinoma, Immunicum AB announced in a press release. The research update presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium showed a survival curve separation in the phase II MERECA trial that gives promising signals for the future.
The combination of ilixadencel plus sunitinib (Sutent) has demonstrated favorable survival compared with sunitinib alone in patients with newly diagnosed metastatic synchronous renal cell carcinoma (mRCC), Immunicum AB announced in a press release. The research update presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium showed a survival curve separation in the phase II MERECA trial (NCT02432846) that gives promising signals for the future.1
“The updated data emphasize that both tumor responses and the durability of patient response with ilixadencel treatment as part of a combination regimen were better compared with sunitinib alone. The addition of ilixadencel did not increase either the frequency or the severity of adverse effects. However, longer follow-up is required before we, with certainty, can comment on any differences in long-term survival,” stated Magnus Lindskog, MD, PhD, associate professor and clinical oncologist at Uppsala University Hospital in Sweden and the principal investigator for the MERECA study.
As of December 2019, the rate of survival observed in the ilixadencel group was 54% compared with 37% in the sunitinib monotherapy group out of 88 patients total. Investigators also observed a 42% confirmed objective response rate in the ilixadencel compared with only 24% in the sunitinib group. Responses lasted for a median of 7.1 months with ilixadencel plus sunitinib and 2.9 months with sunitinib alone. The median progression-free survival was 11.8 months versus 11.0 months in the ilixadencel/sunitinib and sunitinib-only groups, respectively. The median OS was not yet reached in this study.
Fifty-seven percent of patients who received ilixadencel plus sunitinib and 43% of those treated with sunitinib monotherapy were still alive as of July 2019. The addition of ilixadencel to sunitinib did not lead to any new grade 3/4 treatment-related adverse events.1,2
“The fact that ilixadencel, when combined with subsequent sunitinib treatment, induces a nearly 2-fold increase in the confirmed ORR and more complete responses when compared with sunitinib monotherapy is highly encouraging. Additionally, the favorable early separation of the Kaplan-Meier curves that now have been confirmed and the long-term survival projections are interesting,” Alex Karlsson-Parra, CSO, an associate professor and interim CEO of Immunicum, said in a statement.
These data are an improvement from the previously reported topline data announced in September of 2019. The objective ORR was 44% with ilixadencel plus sunitinib and 48% with sunitinib alone, which included complete responses in 11% and 4%, respectively. The percentage of responders who were alive at last patient contact was 85% in the combination group and 58% in the monotherapy group.3
MERECA was an open-label, randomized, controlled multicenter study in which patients were randomized 2:1 to receive a 10 milj cells vaccination of ilixadencel for 14 days following treatment with sunitinib after nephrectomy or sunitinib post-nephrectomy. The coprimary end points of the study were OS and the overall 18-month survival rate from randomization in different subgroups of patients with mRCC. The key secondary end point included the frequency of AEs, PFS, the proportion of ORR from the start of sunitinib and DOR in each group, time to progression, and the relative number of tumor-infiltrating CD8+ T cells in the resected primary tumor compared with related infiltration CD8+ T cells in the available diagnostic pre-biopsy.
To enroll in the study, patients were required to be newly diagnosed with histologically or cytologically confirmed RCC with at least 1 metastasis ≥10 mm for which complete metastasectomy is not planned, as determined by a CAT scan. The primary tumor diameter in these patients must have been at least 40 mm. Additionally, patients were required to have adequate hematologic values, creatinine and bilirubin values, and be candidates for first-line therapy with sunitinib initiated for 5 to 8 weeks after nephrectomy.
Individuals with a prior history of invasive cancer within 5 years of screening, except for situ carcinoma or nonmelanoma skin cancer; those who had prior systemic antitumor therapy within 28 days before screening; and individuals with a poor performance status, certain infections, and comorbidities were excluded from the study.
Ilixadencel is an off-the-shelf cell-based cancer immunotherapy indicated for treatment of hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC. Immunicum AB plans to continue their discussions with regulatory organizations to further develop ilixadencel in other solid tumors.1