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Exelixis' (EXEL) Prostate Cancer Study Meets Primary Endpoint
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Exelixis, Inc. (EXEL - Free Report) and partner Ipsen announced that the late-stage CONTACT-02 study achieved one of the two primary endpoints.
CONTACT-02 is a global, multicenter, randomized, phase III open-label study that enrolled 575 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) and the control arm of a second novel hormonal therapy (either abiraterone and prednisone or enzalutamide).
The study included patients with metastatic castration-resistant prostate cancer (mCRPC) who have measurable visceral disease or measurable extra pelvic adenopathy and who have been previously treated with one novel hormonal therapy. The two primary endpoints of the trial are progression-free survival and overall survival (OS). The secondary endpoint is the objective response rate.
Data from the study showed cabozantinib in combination with Tecentriq demonstrated a statistically significant reduction in the risk of disease progression or death compared with a second novel hormonal therapy in mCRPC patients.
In addition, a trend toward improved OS was observed at a prespecified interim analysis. However, the data was immature and did not meet the threshold for statistical significance. Therefore, the trial will proceed to the next OS analysis as planned.
The safety profile of the combination of cabozantinib and atezolizumab was consistent with the known safety profiles of the individual drugs.
The trial is sponsored by Exelixis and co-funded by Ipsen, Roche and Takeda Pharmaceutical Company Limited.
Per the company, prostate cancer is the second most common cancer in men and the fourth most common cancer globally. It becomes mCRPC when it spreads beyond the prostate and does not respond to androgen-suppression therapies.
These patients face a poor prognosis of less than two years and many who progress on a novel hormonal therapy seek alternative treatment options to chemotherapy.
Hence, encouraging data from the CONTACT-02 study, in which cabozantinib in combination with an immune checkpoint inhibitor demonstrated an efficacy benefit for these patients, increases the chances of approval. The combination represents a potential new treatment option for these patients.
Exelixis plans to discuss the study data with the FDA.
Given its widespread prevalence, the targeted market presents growth opportunity and a potential approval of the combination will be a significant boost.
Exelixis’ shares have gained 32.2% year to date against the industry’s decline of 14.3%.
Image Source: Zacks Investment Research
Cabozantinib tablets are approved in the United States under the brand name Cabometyx for the treatment of patients with advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo.
It is also approved for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.
While Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States, it granted Ipsen exclusive rights in 2016 for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. Exelixis granted exclusive rights to Takeda in 2017 for commercializing and further developing cabozantinib for all future indications in Japan.
Exelixis’ second-quarter results were better than expected as Cabometyx maintained its status as the leading tyrosine kinase inhibitor for the treatment of RCC, driven by its use in combination with Opdivo in the first-line setting.
The drug also maintained growth in the HCC indication. The label expansion of the drug will further boost its sales.
Bristol-Myers’ Opdivo, one of its leading revenue generators, is approved for various oncology indications.
Image: Bigstock
Exelixis' (EXEL) Prostate Cancer Study Meets Primary Endpoint
Exelixis, Inc. (EXEL - Free Report) and partner Ipsen announced that the late-stage CONTACT-02 study achieved one of the two primary endpoints.
CONTACT-02 is a global, multicenter, randomized, phase III open-label study that enrolled 575 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) and the control arm of a second novel hormonal therapy (either abiraterone and prednisone or enzalutamide).
The study included patients with metastatic castration-resistant prostate cancer (mCRPC) who have measurable visceral disease or measurable extra pelvic adenopathy and who have been previously treated with one novel hormonal therapy. The two primary endpoints of the trial are progression-free survival and overall survival (OS). The secondary endpoint is the objective response rate.
Data from the study showed cabozantinib in combination with Tecentriq demonstrated a statistically significant reduction in the risk of disease progression or death compared with a second novel hormonal therapy in mCRPC patients.
In addition, a trend toward improved OS was observed at a prespecified interim analysis. However, the data was immature and did not meet the threshold for statistical significance. Therefore, the trial will proceed to the next OS analysis as planned.
The safety profile of the combination of cabozantinib and atezolizumab was consistent with the known safety profiles of the individual drugs.
The trial is sponsored by Exelixis and co-funded by Ipsen, Roche and Takeda Pharmaceutical Company Limited.
Per the company, prostate cancer is the second most common cancer in men and the fourth most common cancer globally. It becomes mCRPC when it spreads beyond the prostate and does not respond to androgen-suppression therapies.
These patients face a poor prognosis of less than two years and many who progress on a novel hormonal therapy seek alternative treatment options to chemotherapy.
Hence, encouraging data from the CONTACT-02 study, in which cabozantinib in combination with an immune checkpoint inhibitor demonstrated an efficacy benefit for these patients, increases the chances of approval. The combination represents a potential new treatment option for these patients.
Exelixis plans to discuss the study data with the FDA.
Given its widespread prevalence, the targeted market presents growth opportunity and a potential approval of the combination will be a significant boost.
Exelixis’ shares have gained 32.2% year to date against the industry’s decline of 14.3%.
Image Source: Zacks Investment Research
Cabozantinib tablets are approved in the United States under the brand name Cabometyx for the treatment of patients with advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo.
It is also approved for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.
While Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States, it granted Ipsen exclusive rights in 2016 for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. Exelixis granted exclusive rights to Takeda in 2017 for commercializing and further developing cabozantinib for all future indications in Japan.
Exelixis’ second-quarter results were better than expected as Cabometyx maintained its status as the leading tyrosine kinase inhibitor for the treatment of RCC, driven by its use in combination with Opdivo in the first-line setting.
The drug also maintained growth in the HCC indication. The label expansion of the drug will further boost its sales.
Bristol-Myers’ Opdivo, one of its leading revenue generators, is approved for various oncology indications.
Exelixis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.