Immunicum has announced updated results from the randomized Phase II MERECA trial testing its off-the-shelf immune primer ilixadencel in combination with Sutent (sunitinib) first-line treatment regimen in newly diagnosed metastatic renal cell carcinoma (mRCC) patients.
December 2019 data confirm the separation in survival curves in favor of the ilixadencel group that was projected by the Kaplan-Meier curves in the previous update from July 2019, while final median OS values were still not reached. Extended analysis of available data showed that compared to sunitinib monotherapy, combined treatment with ilixadencel demonstrated a nearly two-fold higher confirmed ORR.
The MERECA study evaluated intratumoral ilixadencel administration prior to kidney removal of the primary tumor-affected kidney followed by sunitinib treatment compared with kidney removal, without prior ilixadencel treatment, followed by sunitinib alone as first-line systemic therapy in patients with mRCC. Over a three-year period, 88 patients were randomly assigned in a two-to-one ratio to the ilixadencel combination treatment group or sunitinib control group.
Updated data as of December 2019 demonstrates a separation in Kaplan-Meier survival curves in favor of the ilixadencel treatment group, in line with the projected separation from July 2019. The proportion of patients alive was 54% (30 out of 56) of patients in the ilixadencel treatment group compared with 37% (11 out of 30) of patients in the control group. The median OS value cannot be calculated yet in either group as the data is not mature. Based on data on best overall response and the Duration of Response, Immunicum requested a post-study analysis by the contract research organization of confirmed ORR (a tumor response that is confirmed by a follow-up scan, per RECIST 1.1 criteria). The confirmed ORR for the ilixadencel treatment group was 42.2 % (19/45) versus 24.0% (6/25) for the sunitinib control group.
“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 to sunitinib alone. The addition of ilixadencel did not increase either the frequency or the severity of side effects. However, longer follow-up is required before we with certainty can comment on any differences in long-term survival,” stated Associate Professor Magnus Lindskog, clinical oncologist at Uppsala University Hospital, Sweden and principal investigator in the MERECA study who presented the results.
“The fact that ilixadencel, when combined with subsequent suntinib treatment, induces a nearly 2-fold increase in the confirmed Objective Response Rate and more complete responses when compared to sunitinib monotherapy, is of course highly encouraging. Additionally, the favorable early separation of the Kaplan-Meier curves that now has been confirmed and the long-term survival projections are clearly interesting,” commented Associate Professor Alex Karlsson-Parra, CSO and Interim CEO of Immunicum. “We continue our discussions with regulatory bodies to define the next step in the development of ilixadencel as a treatment for a range of solid tumors.”
Photo of Alex Karlsson Parra, CSO and Interim CEO, Immunicum