Exelixis’ Kidney Cancer Drug Cabometyx Positive in Phase II

Exelixis, Inc. (EXELAnalyst Report) announced positive top-line data from the phase II trial, CABOSUN, on Cabometyx in patients suffering from previously untreated advanced renal cell carcinoma (RCC).

Results showed that Cabometyx led to significant improvement in progression-free survival in patients with previously untreated advanced RCC, compared with sunitinib. Consequently, the trial met its primary endpoint.

Safety data from the Cabometyx arm of the study were consistent with those observed in previous studies in patients with advanced RCC.

Final results of the trial will be presented at a medical conference shortly.

We remind investors that Cabometyx (the tablet formulation of cabozantinib) was approved by the FDA in Apr 2016 for the treatment of patients with advanced RCC, who have received prior anti-angiogenic therapy.

Meanwhile, the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Cabometyx for review in the same indication. Upon a potential approval, the drug would be marketed in the EU by Exelixis’ partner, Ipsen. The MAA has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which translates a review period of 150 days instead of the standard 210 days.

Exelixis also plans to submit results of the CABOSUN trial to regulatory authorities in order to discuss further development of Cabometyx and submission strategy for the treatment of first-line advanced RCC.

As per the American Cancer Society, kidney cancer is one of the top 10 most commonly diagnosed forms of cancer in both men and women in the U.S. Hence, approval of Cabometyx in first-line advanced RCC will boost its growth prospects significantly.

Exelixis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Abbott Laboratories (ABT – Analyst Report) , Johnson & Johnson (JNJ – Analyst Report) and Sanofi (SNY – Analyst Report) . All three stocks carry a Zacks Rank #2 (Buy).

From https://www.zacks.com/stock/news/218403/exelixis-kidney-cancer-drug-cabometyx-positive-in-phase-ii

Pipeline Series: Renal Cell Carcinoma – Cancer Therapy Advisor

In the last decade, the U.S. Food and Drug Administration (FDA) has approved a variety of kinase inhibitors, including sorafenib, temsirolimus, everolimus, sunitinib, pazopanib, and axitinib—all angiogenesis inhibitor— for the treatment of patients with advanced renal cell carcinoma (RCC). Two additional immunotherapeutic agents;  bevacizumab, which is another antiangiogenic agent; and nivolumab are also indicated for advanced RCC.

Cabozantinib

Cabozantinib is an oral, small-molecular tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), like the angiogenesis inhibitors, as well as MET and AXL. An open-label, phase 3 trial comparing the efficacy of cabozantinib to that of everolimus in patients with RCC that had progressed after VEGFR-targeted therapy demonstrated a 42% lower rate of progression or death with cabozantinib.1

“Cabozantinib is very interesting. Data published in The New England Journal of Medicine in September 2015 and an update presented at the 2016 Genitourinary Cancers Symposium showed that the drug beat the second-line standard everolimus in terms of progression-free survival,” said Dr Choueiri, who also serves on the National Comprehensive Cancer Network Kidney & Testicular Cancers Panel and is chairman of the Medical and Scientific Steering Committee of the Kidney Cancer Association…

Source: Pipeline Series: Renal Cell Carcinoma – Cancer Therapy Advisor

New drug improves outcome in treatment resistant kidney cancer – ONA

 

A new drug is proven more effective than standard therapies for advanced kidney cancer in patients with demonstrated drug resistance.A study trial, led by researchers from the Dana-Farber Cancer Institute, compared the effectiveness of a new drug, cabozantinib, with the accepted second-line treatment, everolimus (Affinitor).

The trial enrolled 658 patients with clear cell renal carcinoma; all participants had advanced or metastatic renal cell carcinoma and their disease had worsened following first-line therapy.

Initial therapy for these patients had targeted the vascular endothelial growth factor receptor (VEGFR). Cabozantinib proved to be more effective than everolimus in slowing the growth of cancer in these patients and there were early indications that it may have improved their overall survival as well (progression-free survival was a median of 7.4 months vs 3.8 for those using everolimus).

Toni K. Choueiri, MD, clinical director of the Genitourinary Cancer Treatment Center at Dana-Farber Cancer Institute, and first author of the report, feels that cabozantinib may also have potential as a first-line treatment for kidney cancer.Cabozantinib has received breakthrough therapy designation from the Food and Drug Administration. Report data were published online in the New England Journal of Medicine.

Source: New drug improves outcome in treatment resistant kidney cancer – ONA