Figure 3.

Timeline of MitoTam therapy in patient P1-1.0 in the MitoTam-01 trial. The patient was diagnosed with ccRCC of the left kidney in 1999 and underwent RN. He experienced disease relapse in 2011 and received three lines of palliative TKI therapy. Metastases found in the screening period of the MitoTam-01 trial comprised two lesions in the right kidney and one lesion in Th12. The patient underwent 16 cycles of MitoTam therapy in phase Ib, with two follow-up visits after every 4 cycles of therapy. The disease remained stable throughout MitoTam therapy. Treatment was discontinued due to PE, which was classified as a serious AE, and possibly associated with the treatment. Responses were evaluated according to RECIST 1.1.*Lytic bone lesion with soft tissue component measurable according to RECIST 1.1.

ccRCC, clear cell renal cell carcinoma; RN, radical nephrectomy; TKI, tyrosine kinase inhibitor; Th12, thoracic vertebra Th12; RECIST, Response Evaluation Criteria in Solid Tumors; IC, informed consent; D14 and D28, follow-up visits at days 14 and 28 after day 5 in cycles 4, 8, 12 and 16; CT, computed tomography; SD, stable disease; PR, partial response; PD, progressive disease; PE, pulmonary embolism.