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Immunicum updates survival data from Phase II trial

Immunicum has announced an update on survival data from the randomized Phase II MERECA trial evaluating its off-the-shelf immune primer, ilixadencel, in combination with SutentÒ (sunitinib) first-line treatment regimen in newly diagnosed patients with metastatic renal cell carcinoma (mRCC).

During the trial, 88 patients were randomly assigned in a two-to-one ratio to the ilixadencel combination treatment group or sunitinib control group, and subsequently followed for survival. Based on the updated survival data, the final median OS value was reached in the sunitinib control group, while the median OS has not yet been reached in the ilixadencel treatment group. Follow-up on survival data will be collected and updated continuously at 6-month intervals, with the next update expected in Q1 2021.

The largest and longest study

“As our largest and longest study, the Phase II MERECA trial continues to give us insight into the potential efficacy of ilixadencel in combination with standard-of-care in patients with metastatic tumors. As such, we are encouraged that the data at this stage show that only two injections of ilixadencel continue to have an impact on survival of patients as the median Overall Survival of that group has not yet been reached,” commented Associate Professor Alex Karlsson-Parra, CSO and Interim CEO of Immunicum. “As the data continue to mature, we are able to further analyze which patients most benefit from ilixadencel and design our future studies to maximize our understanding of therapeutic potential for patients.”

Updated data as of August 2020 continue to show a separation in Kaplan-Meier survival curves and indicate a difference in the median OS in favor of the ilixadencel treatment group. The median OS, which is the co-primary endpoint of the study, is defined as the time from randomization at which 50% of patients in each group are still alive. The median OS value was reached in the control group at 25.3 months, while the median OS for the ilixadencel treatment group is not reached yet as the data is not mature. The proportion of patients alive was 43% (24 out of 56) of patients in the ilixadencel treatment group compared with 33% (10 out of 30) of patients in the control group. All five Complete Responders (CRs) in the ilixadencel treatment group are still alive in this follow-up, while, as previously reported, the one CR in the control group died during the first follow-up period.

RMAT designation

Earlier this year, ilixadencel received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) based on the previously communicated results from the Phase II MERECA clinical trial. Immunicum will continue these discussions with regulatory authorities and preparations to determine the next set of priorities and objectives for ilixadencel.

Photo of Alex Karlsson Parra, Interim CEO, Immunicum