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Exelixis's Cabometyx Positive for First-Line Kidney Cancer
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Exelixis, Inc. (EXEL - Free Report) announced results from an analysis of the data from the phase II trial, CABOSUN. The study compared Cabometyx to Pfizer’s (PFE - Free Report) Sutent in the first-line treatment of intermediate- or poor-risk advanced renal cell carcinoma (RCC) patients.
We note that Cabometyx tablets were approved for previously treated advanced kidney cancer in the U.S. in Apr 2016. Cabometyx was also approved in EU in Sep 2016 for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.
An independent radiology review committee has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS) in the CABOSUN trial.
The randomized, open-label, active-controlled phase II trial enrolled 157 patients with advanced RCC. Patients were randomized 1:1 to receive Cabometyx (60 mg once daily) or Sutent (50 mg once daily, four weeks on followed by two weeks off). The trial was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ agreement with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).
As per the analysis from the committee, Cabometyx demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS.
We note that Exelixis plans to submit its supplemental New Drug Application (sNDA) for Cabometyx as a treatment of first-line advanced RCC in the third quarter of 2017.
In May 2016, Exelixis announced that CABOSUN met its primary endpoint as Cabometyx demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Sutent in patients with advanced intermediate- or poor-risk RCC as determined by investigator assessment.
Exelixis’ shares have moved up 50.3% year to date compared with the Zacks classified Medical - Biomedical and Genetics industry’s improvement of 6.4%.
Initial uptake of the drug was encouraging and is expected to propel the top line in the forthcoming quarters in 2017.
A potential label expansion of the drug will further boost results.
Exelixis is developing cabozantinib in a broad development program comprising over 45 clinical studies across multiple indications.
In early 2017, Exelixis inked agreements with Bristol-Myers Squibb (BMY - Free Report) and Roche (RHHBY - Free Report) to collaborate on the development of cabozantinib in combination with immunotherapy agents. Exelixis and Bristol-Myers will evaluate cabozantinib in combination with Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab) in a phase III trial in first-line RCC, and potentially in other tumor types including advanced hepatocellular carcinoma (HCC).
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Exelixis's Cabometyx Positive for First-Line Kidney Cancer
Exelixis, Inc. (EXEL - Free Report) announced results from an analysis of the data from the phase II trial, CABOSUN. The study compared Cabometyx to Pfizer’s (PFE - Free Report) Sutent in the first-line treatment of intermediate- or poor-risk advanced renal cell carcinoma (RCC) patients.
We note that Cabometyx tablets were approved for previously treated advanced kidney cancer in the U.S. in Apr 2016. Cabometyx was also approved in EU in Sep 2016 for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.
An independent radiology review committee has confirmed the primary efficacy endpoint results of investigator-assessed progression-free survival (PFS) in the CABOSUN trial.
The randomized, open-label, active-controlled phase II trial enrolled 157 patients with advanced RCC. Patients were randomized 1:1 to receive Cabometyx (60 mg once daily) or Sutent (50 mg once daily, four weeks on followed by two weeks off). The trial was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ agreement with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).
As per the analysis from the committee, Cabometyx demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS.
We note that Exelixis plans to submit its supplemental New Drug Application (sNDA) for Cabometyx as a treatment of first-line advanced RCC in the third quarter of 2017.
In May 2016, Exelixis announced that CABOSUN met its primary endpoint as Cabometyx demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Sutent in patients with advanced intermediate- or poor-risk RCC as determined by investigator assessment.
Exelixis’ shares have moved up 50.3% year to date compared with the Zacks classified Medical - Biomedical and Genetics industry’s improvement of 6.4%.
Initial uptake of the drug was encouraging and is expected to propel the top line in the forthcoming quarters in 2017.
A potential label expansion of the drug will further boost results.
Exelixis is developing cabozantinib in a broad development program comprising over 45 clinical studies across multiple indications.
In early 2017, Exelixis inked agreements with Bristol-Myers Squibb (BMY - Free Report) and Roche (RHHBY - Free Report) to collaborate on the development of cabozantinib in combination with immunotherapy agents. Exelixis and Bristol-Myers will evaluate cabozantinib in combination with Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab) in a phase III trial in first-line RCC, and potentially in other tumor types including advanced hepatocellular carcinoma (HCC).
Zacks Rank
Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look. See the pot trades we're targeting>>