Bay Area Exelixis' Cabometyx Beats the Pants Off Pfizer's Sutent in Mid-Stage Kidney Cancer Study

Published: Oct 11, 2016

Bay Area Exelixis' Cometriq Beats the Pants Off Pfizer's Sutent in Mid-Stage Kidney Cancer Study October 10, 2016
By Mark Terry, Breaking News Staff

South San Francisco – Exelixis announced positive results from its CABOSUN Phase II trial of cabozantinib in previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease.

Cabometyx (cabozantinib) was compared to patients receiving Pfizer ’s Sutent (sunitinib). The median progression-free survival (PFS) for cabozantinib was 8.2 months. The PFS for patients on sunitinib was 5.6 months.

Currently cabozantinib is approved only in patients who have received therapy previously. Sutent, on the other hand, is approved as a first-line treatment. It is also approved in the U.S. to treat gastrointestinal stromal tumors and pancreatic neuroendocrine tumors. Exelixis’ study was designed in hopes of it being approved as a first-line therapy.

The results of the study, which were presented at the European Society of Medical Oncology congress, demonstrated a 31 percent decrease in disease progression or death in patients on cabometyx compared to patients on Sutent.

“The results presented today support the potential of cabozantinib to become a new therapeutic option for previously untreated patients following their diagnosis with advanced kidney cancer,” said Toni Choueiri, director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute and chair of the CABOSUN study, in a statement. “Not only has cabozantinib surpassed sunitinib, the current standard of care, in progression-free survival and objective response rate, cabozantinib’s effects on progression-free survival were also consistently favorable across patient stratification subgroups including IMDC intermediate versus poor-risk groups and presence or absence of bone metastases.”

As a result of this data, the company plans to submit to the U.S. Food and Drug Administration (FDA) a Supplemental New Drug Application (sNDA) for cabozantinib to treat first-line advanced renal cell carcinoma. The trial was conducted by The Alliance for Clinical Trials in Oncology, which is part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP). Exelixis is also working with the Alliance to move the complete clinical database from the trial to the company.

“The past year has seen a tremendous level of progress in the treatment of kidney cancer, and we are excited to be at the forefront of bringing these advancements to patients,” said Michael Morrissey, president and chief executive officer of Exelixis, in a statement. “Patients in the first-line setting with either intermediate- or poor-risk disease progress rapidly with sunitinib, a current standard of care; therefore, there is a clear need for new options that provide improved clinical benefit in this difficult to treat patient population.”

Exelixis was dubbed earlier this year by Brian Feroldi with The Motley Fool, as a company that could potentially be as strong a growth company as Gilead Sciences was at one time. In February, it announced positive results from its Phase III trial of cabozantinib in advanced RCC, showing a 42 percent reduction in the rate of disease progression or death compared to Novartis ’s Afinitor. In November 2015, the FDA approved Cotellic (cobimetinib) for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib. The company has a deal with Genentech and Roche to develop and market the drug.

Exelixis is currently trading for $13.27.

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