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Exelixis (EXEL) Late-Stage Study in Pancreatic Tumors Positive
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Exelixis, Inc. (EXEL - Free Report) announced positive results from the late-stage CABINET study evaluating cabozantinib in advanced pancreatic neuroendocrine tumors (pNET) or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy.
The phase III CABINET is a multicenter, randomized, double-blinded, placebo-controlled study that enrolled 290 patients in two separate cohorts in the United States. Patients were randomized 2:1 into the cabozantinib or placebo arms of the study in each of the two cohorts. The primary endpoint was progression-free survival in each cohort.
Upon confirmation of disease progression, patients were unblinded and those receiving a placebo were permitted to cross over to open-label therapy with cabozantinib. Secondary endpoints included overall survival, radiographic response rate and safety. The study is sponsored by the National Cancer Institute and is led by The Alliance for Clinical Trials in Oncology.
Data showed cabozantinib substantially prolonged the time without disease progression or death in both of the trial’s cohorts.
Consequently, the Alliance for Clinical Trials in Oncology’s independent Data and Safety Monitoring Board unanimously recommended unblinding and stopping the CABINET study early due to a dramatic improvement in efficacy that was observed at an interim analysis.
The safety profile of cabozantinib observed in the trial was consistent with its known safety profile and no new safety signals were identified.
Exelixis plans to discuss the data with the FDA.
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.
NET refers to cancers that begin in the specialized cells of the body’s neuroendocrine system. In the United States, more than 12,000 people are diagnosed with NET each year and approximately 171,000 people live with the disease.
The successful development and commercialization of the drug for additional indications will boost its sales.
Exelixis’ shares have gained 37% so far this year against the industry’s decline of 13.4%.
Image Source: Zacks Investment Research
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 in the second quarter of 2023. The drug also maintained growth in the HCC indication.
Bristol-Myers’ Opdivo, one of its leading revenue generators, is approved for various oncology indications.
Exelixis is also making efforts to develop the drug for additional indications and expand its target population. Competition is stiff in these oncology indications and targeting a broader population bodes well.
Earlier in the week, Exelixis and partner Ipsen announced that the late-stage CONTACT-02 study achieved one of the two primary endpoints in patients with metastatic castration-resistant prostate cancer (mCRPC) who have measurable visceral disease or measurable extrapelvic adenopathy and who have been previously treated with one novel hormonal therapy.
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.
Other top-ranked stocks in the biotech sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - Free Report) , each carrying a Zacks Rank #2 at present.
The loss per share estimate for SPRO for 2023 has narrowed by 49 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 27 cents to 24 cents for 2023 in the past 30 days. Dynavax has risen 39.6% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.
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Exelixis (EXEL) Late-Stage Study in Pancreatic Tumors Positive
Exelixis, Inc. (EXEL - Free Report) announced positive results from the late-stage CABINET study evaluating cabozantinib in advanced pancreatic neuroendocrine tumors (pNET) or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy.
The phase III CABINET is a multicenter, randomized, double-blinded, placebo-controlled study that enrolled 290 patients in two separate cohorts in the United States. Patients were randomized 2:1 into the cabozantinib or placebo arms of the study in each of the two cohorts. The primary endpoint was progression-free survival in each cohort.
Upon confirmation of disease progression, patients were unblinded and those receiving a placebo were permitted to cross over to open-label therapy with cabozantinib. Secondary endpoints included overall survival, radiographic response rate and safety. The study is sponsored by the National Cancer Institute and is led by The Alliance for Clinical Trials in Oncology.
Data showed cabozantinib substantially prolonged the time without disease progression or death in both of the trial’s cohorts.
Consequently, the Alliance for Clinical Trials in Oncology’s independent Data and Safety Monitoring Board unanimously recommended unblinding and stopping the CABINET study early due to a dramatic improvement in efficacy that was observed at an interim analysis.
The safety profile of cabozantinib observed in the trial was consistent with its known safety profile and no new safety signals were identified.
Exelixis plans to discuss the data with the FDA.
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.
NET refers to cancers that begin in the specialized cells of the body’s neuroendocrine system. In the United States, more than 12,000 people are diagnosed with NET each year and approximately 171,000 people live with the disease.
The successful development and commercialization of the drug for additional indications will boost its sales.
Exelixis’ shares have gained 37% so far this year against the industry’s decline of 13.4%.
Image Source: Zacks Investment Research
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 in the second quarter of 2023. The drug also maintained growth in the HCC indication.
Bristol-Myers’ Opdivo, one of its leading revenue generators, is approved for various oncology indications.
Exelixis is also making efforts to develop the drug for additional indications and expand its target population. Competition is stiff in these oncology indications and targeting a broader population bodes well.
Earlier in the week, Exelixis and partner Ipsen announced that the late-stage CONTACT-02 study achieved one of the two primary endpoints in patients with metastatic castration-resistant prostate cancer (mCRPC) who have measurable visceral disease or measurable extrapelvic adenopathy and who have been previously treated with one novel hormonal therapy.
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.
Zacks Rank and Other Stocks to Consider
Exelixis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Other top-ranked stocks in the biotech sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - Free Report) , each carrying a Zacks Rank #2 at present.
The loss per share estimate for SPRO for 2023 has narrowed by 49 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 27 cents to 24 cents for 2023 in the past 30 days. Dynavax has risen 39.6% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.