Cell-based therapy fails to significantly improve outcomes in metastatic renal cell carcinoma
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The addition of a cell-based immune primer to sunitinib exhibited activity among patients with metastatic renal cell carcinoma, according to randomized phase 2 study results.
However, the combination did not result in statistically significant improvement in objective response rate or OS compared with sunitinib (Sutent, Pfizer) monotherapy, results presented at International Kidney Cancer Symposium: North America showed.
Patients with synchronous metastatic renal cell carcinoma face a poor prognosis. Although single-agent tyrosine kinase inhibitor therapy and use of immune checkpoint inhibitors — either alone or in combination with TKI — have improved the therapeutic landscape; however, treatments for this population remain inadequate and innovative therapies are needed, according to study background.
Börje Ljungberg, MD, PhD, professor of urology at Umeå University in Sweden, and colleagues conducted a multicenter trial to assess the addition of ilixadencel (Immunicum AB) — an allogeneic monocyte-derived dendritic cell therapy — to sunitinib for patients with synchronous metastatic renal cell carcinoma.
The trial included 88 patients. Researchers assigned 58 of them to two doses of ilixadencel — administered intratumorally 2 weeks apart — followed by nephrectomy and sunitinib. The other 30 underwent nephrectomy followed by sunitinib monotherapy.
OS served as the primary endpoint. ORR assessed up to 18 months served as a secondary endpoint.
Results showed longer median OS in the ilixadencel-sunitinib group; however, the difference did not reach statistical significance (35.6 months vs. 25.3 months; HR = 0.73; 95% CI, 0.42-1.27). A comparable percentage of patients assigned the combination and sunitinib monotherapy remained alive at 18 months (63% vs. 66%).
Researchers also reported a higher ORR in the combination group, but the difference did not reach statistical significance (42.2% vs. 24%). Three patients assigned the combination and no patients assigned sunitinib monotherapy achieved complete response.
At the final scheduled imaging at 18 months follow-up, two additional patients assigned the combination and one patient assigned sunitinib had developed a complete response.
All five patients who achieved complete response to the combination remained alive at the latest survival follow-up. The patient who achieved complete response to sunitinib monotherapy had died.
“Intratumoral vaccination with ilixadencel combined with sunitinib had a numerically higher response rate, including longstanding [complete responses], suggesting an immunologic effect of the experimental treatment,” Ljungberg and colleagues wrote.
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Ljungberg B, et al. Abstract 37. Presented at: International Kidney Cancer Symposium: North America; Nov. 4-5, 2022; Austin, Texas.
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