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Exelixis (EXEL) Reports Positive Cabometyx Combo Study Results
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Exelixis (EXEL - Free Report) has announced detailed results from the ongoing phase III study, COSMIC-313. The results will also be presented at the 2022 European Society of Medical Oncology (ESMO) Congress.
The study is evaluating cabozantinib (Cabometyx) in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) and Yervoy (ipilimumab) vis-à-vis the combination of Opdivo and Yervoy in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma (RCC).
Patients were randomized 1:1 into the experimental or control arms of the study. The primary endpoint is progression-free survival (PFS), and the secondary endpoint is overall survival (OS).
The study was designed to evaluate whether adding cabozantinib to dual checkpoint inhibition can improve outcomes for this poor- and intermediate-risk RCC patient population.
Results showed the triplet combination significantly reduced the risk of disease progression or death compared with the combination of Opdivo and Yervoy.
Median PFS was not reached for the triplet combination and was 11.3 months for the combination of Opdivo and Yervoy. Objective response rates in the PFS intent-to-treat population, as assessed by Blinded Independent Radiology Committee (BIRC), were 43% and 36%, respectively. The median duration of response was not reached in either treatment arm.
At a prespecified interim analysis for the secondary endpoint of OS, the triplet combination versus the combination of nivolumab and ipilimumab did not demonstrate a significant benefit. Therefore, the trial will continue to the next analysis of OS.
Exelixis plans to approach the FDA to discuss a potential regulatory submission based on the progression-free survival data.
Exelixis is funding the trial, and Bristol Myers is providing nivolumab and ipilimumab for use in this trial.
The successful results of the same increase the growth potential of Cabometyx.
Exelixis’ shares have lost 2.4% in the year so far compared with the industry’s decline of 24%.
Image Source: Zacks Investment Research
Exelixis’ lead drug Cabometyx, approved for treating patients with RCC and patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar, aids the company’s momentum amid stiff competition. In particular, the approval of Cabometyx for patients with advanced RCC as a first-line treatment in combination with Opdivo has fueled sales of the drug.
Competition is stiff in the RCC space, and capturing additional market share might become tough for Exelixis. The landscape in RCC treatment is rapidly changing, and new immunotherapy combinations are supposed to improve outcomes in these patient populations.
Loss estimates for BOLT have narrowed to $2.54 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.
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Exelixis (EXEL) Reports Positive Cabometyx Combo Study Results
Exelixis (EXEL - Free Report) has announced detailed results from the ongoing phase III study, COSMIC-313. The results will also be presented at the 2022 European Society of Medical Oncology (ESMO) Congress.
The study is evaluating cabozantinib (Cabometyx) in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) and Yervoy (ipilimumab) vis-à-vis the combination of Opdivo and Yervoy in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma (RCC).
Patients were randomized 1:1 into the experimental or control arms of the study. The primary endpoint is progression-free survival (PFS), and the secondary endpoint is overall survival (OS).
The study was designed to evaluate whether adding cabozantinib to dual checkpoint inhibition can improve outcomes for this poor- and intermediate-risk RCC patient population.
Results showed the triplet combination significantly reduced the risk of disease progression or death compared with the combination of Opdivo and Yervoy.
Median PFS was not reached for the triplet combination and was 11.3 months for the combination of Opdivo and Yervoy. Objective response rates in the PFS intent-to-treat population, as assessed by Blinded Independent Radiology Committee (BIRC), were 43% and 36%, respectively. The median duration of response was not reached in either treatment arm.
At a prespecified interim analysis for the secondary endpoint of OS, the triplet combination versus the combination of nivolumab and ipilimumab did not demonstrate a significant benefit. Therefore, the trial will continue to the next analysis of OS.
Exelixis plans to approach the FDA to discuss a potential regulatory submission based on the progression-free survival data.
Exelixis is funding the trial, and Bristol Myers is providing nivolumab and ipilimumab for use in this trial.
The successful results of the same increase the growth potential of Cabometyx.
Exelixis’ shares have lost 2.4% in the year so far compared with the industry’s decline of 24%.
Image Source: Zacks Investment Research
Exelixis’ lead drug Cabometyx, approved for treating patients with RCC and patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar, aids the company’s momentum amid stiff competition. In particular, the approval of Cabometyx for patients with advanced RCC as a first-line treatment in combination with Opdivo has fueled sales of the drug.
Competition is stiff in the RCC space, and capturing additional market share might become tough for Exelixis. The landscape in RCC treatment is rapidly changing, and new immunotherapy combinations are supposed to improve outcomes in these patient populations.
Exelixis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.54 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.