Dr. Agarwal on Updated Results of the JAVELIN Renal 101 Trial in Advanced RCC

Neeraj Agarwal, MD
Published: Thursday, Apr 18, 2019



Neeraj Agarwal, MD, professor of medicine, physician and investigator, director, Genitourinary Oncology Program, Center of Investigational Therapeutics, Huntsman Cancer Institute, University of Utah, discusses the updated results of the JAVELIN Renal 101 trial in advanced renal cell carcinoma (RCC).

Originally presented at the 2018 ESMO Congress, the JAVELIN Renal 101 trial randomized over 800 patients to receive the combination of axitinib (Inlyta) plus avelumab (Bavencio) versus sunitinib (Sutent). Updated results from the trial showed a 5-month difference in progression-free survival (PFS) between arms among the overall population. In the control arm, the PFS was approximately 8 months compared with 13 months in the experimental arm. Response rates were superior in the combination arm by approximately 25%; however, the complete remission rate was 3%.

As these results are comparable to those of the phase III KEYNOTE-426 trial, it leaves physicians wondering what the best way to use these agents is, says Agarwal. Two years ago, the standard approach was to start with sunitinib. Now, many options, such as cabozantinib (Cabometyx) monotherapy, pembrolizumab (Keytruda) plus axitinib, axitinib plus avelumab, and ipilimumab (Yervoy) plus nivolumab (Opdivo), are available. Combinations of lenvatinib (Lenvima) plus pembrolizumab and cabozantinib-based combinations are also expected in the future, says Agarwal.
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Neeraj Agarwal, MD, professor of medicine, physician and investigator, director, Genitourinary Oncology Program, Center of Investigational Therapeutics, Huntsman Cancer Institute, University of Utah, discusses the updated results of the JAVELIN Renal 101 trial in advanced renal cell carcinoma (RCC).

Originally presented at the 2018 ESMO Congress, the JAVELIN Renal 101 trial randomized over 800 patients to receive the combination of axitinib (Inlyta) plus avelumab (Bavencio) versus sunitinib (Sutent). Updated results from the trial showed a 5-month difference in progression-free survival (PFS) between arms among the overall population. In the control arm, the PFS was approximately 8 months compared with 13 months in the experimental arm. Response rates were superior in the combination arm by approximately 25%; however, the complete remission rate was 3%.

As these results are comparable to those of the phase III KEYNOTE-426 trial, it leaves physicians wondering what the best way to use these agents is, says Agarwal. Two years ago, the standard approach was to start with sunitinib. Now, many options, such as cabozantinib (Cabometyx) monotherapy, pembrolizumab (Keytruda) plus axitinib, axitinib plus avelumab, and ipilimumab (Yervoy) plus nivolumab (Opdivo), are available. Combinations of lenvatinib (Lenvima) plus pembrolizumab and cabozantinib-based combinations are also expected in the future, says Agarwal.



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