Dr. Voss on Phase I/II Trial Data of MEDI0680/Durvalumab Versus Nivolumab in mRCC

Martin H. Voss, MD
Published: Friday, Dec 06, 2019



Martin H. Voss, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses results of a randomized phase I/II trial (NCT02118337) looking at the combination of MEDI0680 and durvalumab (Imfinzi) versus nivolumab (Opdivo) in metastatic renal cell carcinoma (mRCC).

For the phase I/II trial, investigators set out to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab compared with nivolumab monotherapy in immunotherapy-naïve patients with metastatic clear cell renal cell carcinoma.

However, no significant difference in overall response rate, progression-free survival, or overall survival was observed between the 2 arms of this trial, says Voss. Furthermore, no subgroups appeared to derive additional benefit from the combination versus the single-agent, explains Voss.

Results from a safety analysis showed that grade 3/4 treatment-related adverse events (TRAEs) occurred in 26% of patients who received the combination versus 19% who received nivolumab. Furthermore, 12% of patients discontinued treatment as a result of TRAEs compared with 5%, respectively, Voss concludes.
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Martin H. Voss, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses results of a randomized phase I/II trial (NCT02118337) looking at the combination of MEDI0680 and durvalumab (Imfinzi) versus nivolumab (Opdivo) in metastatic renal cell carcinoma (mRCC).

For the phase I/II trial, investigators set out to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab compared with nivolumab monotherapy in immunotherapy-naïve patients with metastatic clear cell renal cell carcinoma.

However, no significant difference in overall response rate, progression-free survival, or overall survival was observed between the 2 arms of this trial, says Voss. Furthermore, no subgroups appeared to derive additional benefit from the combination versus the single-agent, explains Voss.

Results from a safety analysis showed that grade 3/4 treatment-related adverse events (TRAEs) occurred in 26% of patients who received the combination versus 19% who received nivolumab. Furthermore, 12% of patients discontinued treatment as a result of TRAEs compared with 5%, respectively, Voss concludes.



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