FDA Grants Breakthrough Therapy Status to Lenvima-Keytruda Combo for Advanced Kidney Cancer

FDA Grants Breakthrough Therapy Status to Lenvima-Keytruda Combo for Advanced Kidney Cancer

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eisai’s Lenvima (lenvatinib), in combination with Merck’s Keytruda (pembrolizumab), to treat patients with advanced renal cell carcinoma (RCC).

The FDA awards this designation to therapies that provide significant improvement over currently available ones. It aims to accelerate the development, review and approval of medicines.

“As a human health care company dedicated to giving our first thought to patients, we are committed to working closely with Merck and the FDA to expedite this clinical program with the hope that we may offer another important option for patients in need,” Takashi Owa, vice president and chief medicine creation officer of Eisai’s Oncology Business Group said in a press release.

The FDA based its ruling on results of Study 111 (NCT02501096), a multicenter, open-label Phase 1b/2 trial conducted in 55 clinical sites across the United States and Spain.

The study is evaluating the safety and efficacy of Lenvima plus Keytruda in multiple solid tumors, including RCC, non-small cell lung cancer, endometrial cancer, urothelial cancer, squamous cell carcinoma of the head and neck, and melanoma. Participants had unresectable tumors and their disease had progressed following treatment with approved therapies.

In Phase 1b, researchers tested multiple Lenvima doses, combined with a fixed Keytruda dose (200 mg every three weeks), to find the maximum tolerated dose. Then, in Phase 2, patients received oral Lenvima (20 mg) once a day plus Keytruda for up to 24 weeks. Due to reported toxicity, reduced doses of Lenvima were also tested.

In this part of Study 111, researchers evaluated the objective response rate at 24 weeks as a primary endpoint. Secondary measures included disease control rate, progression-free survival and duration of response. This part is currently ongoing, expanded enrollment in the endometrial cancer group.

“The FDA’s Breakthrough Therapy Designation for the Lenvima and Keytruda combination in advanced and/or metastatic renal cell carcinoma provides us with the opportunity to accelerate our effort to bring an important potential treatment option to these patients,” said Roy Baynes, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories.

In 2012, roughly 338,000 people worldwide had renal cancer, including 58,000 in the United States, 115,000 in Europe and 17,000 in Japan. The average age of a renal cancer diagnosis is 64, and the disease is more likely to affect men than women.

“We remain committed to understanding the full potential of Keytruda across cancers and treatment settings, and our collaboration with Eisai is one of the many ways we are executing on this commitment to helping more patients,” said Baynes.

Lenvima is a kinase inhibitor that is already approved, in combination with Afinitor (everolimus), for patients with advanced RCC who received one prior anti-angiogenic therapy. This is the second time it has been designated as breakthrough therapy. For Keytruda, it is the twelfth time.

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