The vaccine IMA901 did not improve overall survival when added to sunitinib as a first-line treatment for patients with metastatic renal cell carcinoma (RCC), according to a study published in The Lancet Oncology.1
Researchers led by Brian Rini, MD, of the Cleveland Clinic Taussig Cancer Center in Ohio examined the data of 1171 patients with treatment-naive, histologically confirmed metastatic or locally advanced RCC in the open-label, randomized, controlled, phase 3 IMPRINT (IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma; ClinicalTrials.gov Identifier: NCT01265901) trial.
Patients were randomly assigned to receive sunitinib with up to 10 intradermal vaccinations of IMA901 as well as granulocyte macrophage colony-stimulating factor with 1 dose of cyclophosphamide 3 days before the first vaccination, or sunitinib alone. Through intention to treat analysis, investigators examined for overall survival from randomization until death of any cause.
In total, 204 patients received sunitinib plus IMA901 and 135 received sunitinib alone.
Median overall survival was 33.17 months in the sunitinib plus IMA901 group and 33.67 in the sunitinib alone group.
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Additionally, 116 of the 202 patients (57%) in the sunitinib with IMA901 group as well as 62 of the 132 patients (47%) in the sunitinib alone group had grade 3 or worse adverse events. Serious adverse events leading to death occurred in 4 patients in the sunitinib with IMA901 group and 8 patients in the sunitinib only group.
- Rini BI, Stenzl A, Zdrojowy R, et al. IMA901, a multipeptide cancer vaccine, plus sunitinib versus sunitinib alone, as first-line therapy for advanced or metastatic renal cell carcinoma (IMPRINT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Oct 3. doi: 10.1016/S1470-2045(16)30408-9 [Epub ahead of print]