A combination of ilixadencel plus first-line treatment with Sutent (sunitinib) prolonged overall survival to a clinically meaningful extent in newly diagnosed patients with metastatic renal cell carcinoma (mRCC), a form of kidney cancer, a Phase 2 trial found.
People given this combo treatment in the MERECA trial (NCT02432846) lived 10 months longer than those on Sutent alone. While the study was not designed to determine a statistical difference in survival outcomes, this finding suggests that Immunicum’s ilixadencel aids survival in these patients.
“These updated results from the Phase II MERECA trial underscore the positive impact on overall survival that ilixadencel may achieve for kidney cancer patients,” Sven Rohmann, MD, PhD, the company’s CEO, said in a press release.
“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,” Rohmann said.
Ilixadencel is an investigational anti-cancer vaccine that uses dendritic cells, a type of immune cell, to instruct T-cells to attack and destroy cancer cells.
After being isolated from healthy donors, dendritic cells undergo a procedure to become activated and produce certain substances that trigger strong immune responses. Once this procedure is complete, these cells are injected directly into the tumor, where they work to trigger an inflammatory response and promote the recruitment of cancer-killing T-cells.
The MERECA study enrolled 88 newly diagnosed mRCC patients, who were randomly divided, 2:1, into two treatment groups: those in the intervention group received two injections of ilixadencel, followed by surgery to remove the cancerous kidney, and treatment with Sutent; those in the control group went directly to the surgery, followed by Sutent.
Main trial goals were to assess if the addition of ilixadencel could prolong the time patients lived, and increase the proportion of those still alive after 18 months of follow-up. Additional goals looked at treatment safety and patients’ response rates.
Early data from MERECA showed that more than half of the patients in both groups — 63% in the intervention and 66% in the control group — were alive at the 18-month point. At that time, median overall survival had not been reached in either group, indicating both treatment regimens were associated with high survival rates.
A more recent analysis, based on data gathered up to December 2019, showed a higher proportion of combination therapy patients alive than those given Sutent alone (54% vs. 37%).
This analysis also found combination patients more likely to respond to treatment, and to achieve longer-lasting responses than those treated with Sutent after surgery.
Immunicum now presented the latest findings from MERECA, based on data collected up to February. Updated survival data continues to favor the combination therapy, in line with previous findings.
These data show that combination patients lived for a median of 35.6 months, while those in the control group lived for a median of 25.3 months, a difference considered clinically meaningful. The percentage of patients still alive at the February analysis also favored the combination group (41% vs. 30%).
“The observed difference of 10 months in median OS [overall survival] for the ilixadencel combination group versus the control group is substantial and clinically meaningful,” said Peter Suenaert, MD, PhD, 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,” Suenaert added.
All five intervention group patients who achieved a complete response (full cancer elimination) were also alive at this updated analysis. The single control group patient who reached a complete response died during the study’s initial follow-up, the company reported.
Immunicum plans to provide annual survival rate updates on patients in MERECA who are still under monitoring.