Dr. Powles on Rationale for KEYNOTE-426 in mRCC

Thomas Powles, MBBS, MRCP, MD
Published: Monday, Mar 11, 2019



Thomas Powles, MBBS, MRCP, MD, director, Barts Cancer Institute, discusses the rationale for the KEYNOTE-426 study in patients with metastatic renal cell carcinoma (mRCC).

For the frontline treatment of patients with mRCC, there are 2 main classes of agents available for use. There are the VEGF inhibitors sunitinib (Sutent) and axitinib (Inlyta), which have more similarities than differences, Powles says, and there are also checkpoint inhibitors such as pembrolizumab (Keytruda). Both classes of drugs have single-agent activity with response rates around 35%, as well as FDA-approved frontline indications. A phase Ib study showed that when these agents are combined, response rates can be increased to over 60%.

Powles says that with the KEYNOTE-426 trial of pembrolizumab and axitinib, investigators were hoping to develop a randomized phase III study of a novel combination that would beat a benchmark control arm—in this case, the frontline standard: sunitinib. Findings presented at the 2019 Genitourinary Cancers Symposium showed a 47% reduction in the risk of death with the combination. As a result of these data, in February 2019, the FDA granted a priority review designation to a supplemental biologics license for the combination.
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Thomas Powles, MBBS, MRCP, MD, director, Barts Cancer Institute, discusses the rationale for the KEYNOTE-426 study in patients with metastatic renal cell carcinoma (mRCC).

For the frontline treatment of patients with mRCC, there are 2 main classes of agents available for use. There are the VEGF inhibitors sunitinib (Sutent) and axitinib (Inlyta), which have more similarities than differences, Powles says, and there are also checkpoint inhibitors such as pembrolizumab (Keytruda). Both classes of drugs have single-agent activity with response rates around 35%, as well as FDA-approved frontline indications. A phase Ib study showed that when these agents are combined, response rates can be increased to over 60%.

Powles says that with the KEYNOTE-426 trial of pembrolizumab and axitinib, investigators were hoping to develop a randomized phase III study of a novel combination that would beat a benchmark control arm—in this case, the frontline standard: sunitinib. Findings presented at the 2019 Genitourinary Cancers Symposium showed a 47% reduction in the risk of death with the combination. As a result of these data, in February 2019, the FDA granted a priority review designation to a supplemental biologics license for the combination.

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