Rocapuldencel-T Plus Sunitinib in Metastatic Renal Cell Carcinoma
Posted: Tuesday, April 28, 2020
In the phase III ADAPT trial, Robert A. Figlin, MD, of the Cedars-Sinai Medical Center, Los Angeles, and colleagues found that rocapuldencel-T in combination with sunitinib did not appear to improve overall survival among patients with metastatic renal cell carcinoma. However, the researchers suggested the induced immune response correlated with overall survival. The findings, published in Clinical Cancer Research, also identified two biomarkers that may predict survival among patients who received dendritic cell–based immunotherapy.
Eligible patients with metastatic renal cell carcinoma (n = 462) were randomly assigned 2:1 to receive rocapuldencel-T—an autologous immunotherapy created from mature monocyte-derived dendritic cells—plus high-dose interleukin-2 (IL-2) and interferon alpha (IFN-α) or the standard of care alone (IL-2 plus IFN-α). Overall, 307 patients were treated with the combination therapy, and 155 patients received the standard of care. The median follow-up was 29 months.
The median overall survival in the combination group was 27.7 months versus 32.4 months in the standard-of-care group. Similarly, the combination therapy did not improve progression-free survival (6.0 months vs. 7.8 months). The overall response rate for the combination group was 42.7% versus 39.4% for the standard-of-care group.
In 2017, the ADAPT trial was discontinued based on a lack of clinical efficacy. However, the research team detected immune responses in 70% of patients treated with rocapuldencel-T, and the magnitude of the response was positively correlated with overall survival. The research team measured the predictive values of IL-12 produced by the dendritic cell vaccine. They found that high baseline numbers of T regulatory cells were associated with improved outcomes among patients treated with this immunotherapy, although they were associated with poor outcomes among patients who received the standard of care.
Disclosure: For full disclosures of the study authors, visit clincancerres.org.