Novartis Pharmaceuticals Corporation has announced an agreement with Eisai Inc. to collaborate on commercial and certain medical affairs activities in the United States (US) to co-promote Lenvima* (lenvatinib) capsules used in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. Everolimus is marketed by Novartis as Afinitor® tablets. The collaboration follows the US Food and Drug Administration (FDA) approval last month of Lenvima in combination with everolimus for this indication, the only VEGF-mTOR inhibitor regimen approved in the US for patients with advanced RCC. Lenvima was granted Breakthrough Therapy designation by the FDA for this indication.
Under the terms of the collaboration agreement, Novartis and Eisai will promote the availability of this combination regimen to appropriate healthcare professionals nationwide, and participate in certain joint medical affairs activities to facilitate appropriate medical use of and medical education regarding the combination. Each company will continue to book sales of its respective product.
"The goal of this collaboration is to inform physicians that they have a new breakthrough treatment option that simultaneously blocks two key pathways in advanced renal cell carcinoma," said Bruno Strigini, President of Novartis Oncology. "Novartis Oncology's long experience in RCC coupled with Eisai's equal commitment to cancer patients offers a combination of expertise we believe will be a positive force for the RCC community."
RCC is the most common type of kidney cancer in adults, and accounts for 90% of malignant kidney tumors. In 2016, nearly 63,000 people will be diagnosed with RCC in the US. Roughly one-third of patients with RCC has metastatic, or advanced, cancer at the time of diagnosis, meaning that the cancer has spread to other parts of the body. Two primary molecular pathways involved in the progression of advanced RCC are the mammalian target of rapamycin (mTOR) pathway and the vascular endothelial growth factor (VEGF) pathway; everolimus inhibits the mTOR pathway and Lenvima targets the VEGF pathway. A key treatment goal in aRCC is to block the growth of the tumor for as long as possible.
The combination treatment was approved by the FDA on May 13, 2016, based on results of Study 205, Eisai's Phase II registration trial. Study 205 was a multicenter, randomized trial in 153 patients with unresectable advanced or metastatic RCC who were previously treated with an anti-angiogenic therapy and randomized 1:1:1 to receive a combination of 18 mg Lenvima plus 5 mg everolimus, Lenvima only (24 mg once a day) or everolimus only (10 mg once a day) administered orally in continuous 28-day cycles until disease progression or unacceptable toxicity. The primary efficacy endpoint of this study was investigator-assessed progression free survival (PFS), or time from randomization until disease progression or death. Other endpoints of the study included objective response rate (ORR), overall survival (OS) and safety.