Dr. Makker on Safety Signals With Lenvatinib and Pembrolizumab in Endometrial Cancer

Vicky Makker, MD
Published: Thursday, Nov 29, 2018



Vicky Makker, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses safety signals with the combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) in endometrial cancer.

In a study of the combination, no new safety signals were identified. The side effects that are typical of these agents were predicted and anticipated, says Makker. Common toxicities that were noted were high blood pressure, which is a common on-target effect of lenvatinib. Fatigue, diarrhea, hypertension, and a loss of appetite were also observed. However, these side effects were effectively managed with supportive care, dose holds and dose reductions with lenvatinib.

The data that has been acquired so far suggest that the combination should be moved forward in development. Specifically, it will be tested in a phase III trial in patients with microsatellite stability, a population, states Makker, that comprises the majority of recurrent endometrial carcinoma cases.

In August 2018, the FDA granted a breakthrough therapy designation to the combination for the treatment of patients with advanced and/or metastatic non–microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy.
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Vicky Makker, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses safety signals with the combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) in endometrial cancer.

In a study of the combination, no new safety signals were identified. The side effects that are typical of these agents were predicted and anticipated, says Makker. Common toxicities that were noted were high blood pressure, which is a common on-target effect of lenvatinib. Fatigue, diarrhea, hypertension, and a loss of appetite were also observed. However, these side effects were effectively managed with supportive care, dose holds and dose reductions with lenvatinib.

The data that has been acquired so far suggest that the combination should be moved forward in development. Specifically, it will be tested in a phase III trial in patients with microsatellite stability, a population, states Makker, that comprises the majority of recurrent endometrial carcinoma cases.

In August 2018, the FDA granted a breakthrough therapy designation to the combination for the treatment of patients with advanced and/or metastatic non–microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy.



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