Eisai Co., Ltd. and Merck, have announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for LENVIMA® (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab).
This designation is for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma (EC) who have progressed following at least one prior systemic therapy.
The LENVIMA/KEYTRUDA combination therapy is being jointly developed by Eisai and Merck (known as MSD outside the United States and Canada) as part of the strategic collaboration announced in March 2018. This is the third Breakthrough Therapy designation for LENVIMA and the second Breakthrough Therapy designation for LENVIMA in combination with KEYTRUDA, following the Breakthrough Therapy designation for the combination for advanced and/or metastatic renal cell carcinoma announced in January 2018.
The Breakthrough Therapy designation is an FDA program intended to expedite development and review of medicines for serious or life-threatening conditions. In order to qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint.
This Breakthrough Therapy designation was based on interim results of the EC cohort in Study 111/KEYNOTE-146. This is a multicenter, open-label, single-arm Phase 1b/2 basket trial evaluating the efficacy and safety of LENVIMA in combination with KEYTRUDA in patients with selected solid tumors.
The combination of LENVIMA and KEYTRUDA is investigational. The efficacy and safety of this combination has not been established. The LENVIMA/KEYTRUDA combination is not approved in any cancer types today.
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories said, “This second Breakthrough Therapy designation for the LENVIMA/KEYTRUDA combination represents another step forward in our collaboration with Eisai and supports the continued evaluation of this combination in more than 11 types of cancer.”
Dr. Takashi Owa, Vice President and Chief Medicine Creation Officer, Oncology Business Group, Eisai said, “We designed Study 111 to learn as much as we could about the LENVIMA/KEYTRUDA combination as efficiently as possible, driven by a sense of urgency to bring forward a potential new treatment option for patients in need. We are encouraged by the continued activity seen in patients with endometrial carcinoma.”