MERECA Trial Meets OS Endpoint with Ilixadencel/Sunitinib in mRCC

Updated survival data from the phase II MERECA trial (NCT02432846) of the combination ilixadencel and sunitinib (Sutent) favored the combination over sunitinib alone for patients with metastatic renal cell carcinoma (mRCC), according to a press release from Immunicum AB.¹

Immunicum AB, the developers of ilxadencel, announced that median overall survival (OS) for the combination treatment group was reached at 35.6 months, in comparison to 25.3 months for patients on sunitinib alone. Moreover, the data demonstrated a separation in the Kaplan-Meier survival curves in favor of ilixadencel and sunitinib. This indicated a potential survival benefit for patients with mRCC on the chemoimmunotherapy combination. Researchers will continue to release updated data after a 12-month follow-up period.

“These updated results from the Phase II MERECA trial underscore the positive impact on overall survival that ilixadencel may achieve for kidney cancer patients,” commented Sven Rohmann, MD, PhD, chief executive officer, Immunicum, in a press release. “With [these] longer follow-up data, the encouraging signal observed has matured and builds our conviction to bring ilixadencel to patients in need. With our ongoing evaluation of ilixadencel, we are working to provide further clinical evidence supporting our conviction.”

Eighty-eight newly diagnosed patients with mRCC were enrolled in the international controlled and open-label phase II clinical trial randomized 2:1 on either two intratumoral injections of ilixadencel, before nephrectomy, followed by sunitinib, or sunitinib therapy alone post-nephrectomy. Eligible patients were those 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, and a primary tumor diameter of at least 40 mm. Subjects enrolled were also 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.

The primary endpoints of the open-label, randomized, controlled, multicenter study were median OS and 18-month survival rates, in August of 2020 the median OS primary endpoint was reached at 25.3 months prior to the updated data in February this year showing the combination arm reached the median OS endpoint. Of the 41% (23 out of 56) alive in the ilixadencel combination arm 5 achieved complete tumor response and were still alive at the time of follow-up, whereas the one patient who had a complete tumor response on sunitinib alone died during the first follow-up period. At the time of follow up, 30% of patients in the control arm were alive (9 out of 30).

Prior findings from the MERECA study were presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium, the OS rate was 54% in the ilixadencel group compared to 37% in the sunitinib group. Moreover, patients in the combination arm showed a 42% confirmed objective response rate to 24% in the monotherapy group, with responses lasting a median of 7.1 months and 2.9 months respectively. Median progression-free survival was 11.8 months in the ilixadencel and sunitinib group compared to 11 months in the sunitinib-only group.²

“The observed difference of 10 months in median OS for the ilixadencel combination group versus the control group is substantial and clinically meaningful,” said Peter Suenaert, MD, PhD, chief medical officer at Immunicum, in a statement.¹ “Although the randomized, controlled study was not statistically powered for the OS endpoint, [these data] suggests that ilixadencel has the potential to become a promising treatment option for these patients by improving survival outcomes when combined with standard-of-care cancer therapies.”

Secondary objectives of the MERECA trial included evaluating safety and tolerability of the combination treatment, which were consistent with previous evaluations. Ilixadencel is an off-the-shelf cell-based immunotherapy indicated for solid tumors like hepatocellular carcinoma, gastrointestinal stromal tumors, and mRCC. Ilixadencel has been tested in these cancers in combination with several standard-of-care cancer therapies like chemotherapy. Immunicum will continue to update the phase 2 trial as it looks to expand indications for ilixandencel.

References:

1. Immunicum announces encouraging signs of survival benefit in phase II MERECA trial of ilixadencel inkKidney cancer. News release. Immunicum AB. Feburary 22, 2021. Accessed February 25, 2021. https://immunicum.se/investors/press-releases/press/?xml_id=2179199.

2. Immunicum AB (publ) presents updated data from phase II MERECA trial of ilixadencel in kidney cancer at asco-sitc clinical immuno-oncology symposium. News release. Immunicum AB. February 6, 2020. Accessed February 7, 2020. bit.ly/2wopYaL.