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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Breakthrough therapy status to Lenvima-Keytruda combination for advanced liver cancer

The FDA has granted breakthrough therapy designation to Keytruda in combination with Lenvima as a first-line treatment for patients with advanced unresectable hepatocellular carcinoma (HCC) that is not suitable for localized treatment.

FDA’s breakthrough therapy designation is a process designed to accelerate the development and review of drugs that are intended to treat a serious condition. It is given to medications that provide significant advantages over currently available options.

Keytruda, developed by Merck, is an anti-PD-1 checkpoint blockade immunotherapy that has been approved by the FDA and by the European Medicines Agency for treating several types of cancer. Lenvima is an oral kinase inhibitor, developed by Eisai, that has been approved for the treatment of patients with advanced renal cell carcinoma. Kinases are specific enzymes found in cells that are involved in blood vessel formation, and tumor growth and progression and lenvima has been shown to meant to prevent that.

This is the third breakthrough therapy designation for the combination therapy. The first two Breakthrough Therapy designations for the combination were in advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic endometrial carcinoma, received in January 2018 and July 2018, respectively.

The FDA’s decision to grant this designation for HCC was based on the latest findings from the Phase 1b KEYNOTE-52 study which showed positive responses in HCC patients. The ongoing trial is evaluating the safety and efficacy of the Lenvima-Keytruda combo in patients with advanced HCC. All participants were treated with Keytruda administered intravenously at a dose of 200 mg every three weeks, in combination with Lenvima administered orally at a daily dose of 8 mg or 12 mg, depending on the patient’s body weight.

The trial is divided into two parts: an initial phase to determine the safety and tolerability of the combination therapy, and a second expansion phase to examine the patients’ objective responses and duration of responses to the therapy. The safety and tolerability of the combination therapy has been confirmed during the first part of the trial. Analysis of the patients’ responses to treatment is now underway.

Source: Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib) plus KEYTRUDA® (pembrolizumab) Combination Treatment; Press Release

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