Immunicum Announces Encouraging Signs of Survival Benefit in Phase II MERECA Trial of Ilixadencel in Kidney Cancer

Press Release

22 February 2021

Immunicum Announces Encouraging Signs of Survival Benefit in Phase II MERECA Trial of Ilixadencel in Kidney Cancer

-- Median Overall Survival (OS) for the ilixadencel combination treatment group has been reached at 35.6 months, as compared to 25.3 months for the sunitinib control group, indicating a potential survival benefit  for patients in the ilixadencel combination group

Immunicum AB (publ) today announced updated survival data from the Company’s randomized Phase II MERECA trial evaluating its off-the-shelf immune primer, ilixadencel, in combination with sunitinib in the first-line treatment of newly diagnosed patients with metastatic renal cell carcinoma (mRCC). In the MERECA study, 88 patients were randomly assigned to the ilixadencel combination group, or sunitinib control group, and subsequently followed for survival. As previously reported in August 2020, the co-primary endpoint of median OS was reached at 25.3 months in the sunitinib control group, while the median OS in the ilixadencel treatment group has now been reached at 35.6 months.

“The observed difference of 10 months in median OS for the ilixadencel combination group versus the control group is substantial and clinically meaningful,” stated Peter Suenaert, M.D., Ph.D., Chief Medical Officer at Immunicum. “Although the randomized, controlled study was not statistically powered for the OS endpoint, the data announced today 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.”

“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, M.D., Ph.D., CEO at Immunicum. “With today’s 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.”

Updated data as of February 2021 demonstrate a separation in Kaplan-Meier survival curves in favor of the ilixadencel combination treatment, in line with the projected separation from August 2020. The median OS was 35.6 months for the ilixadencel combination group, as compared to 25.3 months in the control group. The proportion of patients alive was 41% (23 out of 56) in the ilixadencel combination treatment group, compared to 30% (9 out of 30) in the control group. All five patients with complete tumor response as best response in the ilixadencel combination treatment group are still alive in this follow-up, as compared to the one with complete response in the control group who had died during the first follow-up period. Moving forward, survival updates for patients in the MERECA study will be announced for each consecutive 12-month follow-up period.