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.
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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.
Reference
- 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]
