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Corcept Korlym Positive in Phase I/II Breast Cancer Study
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Corcept Therapeutics Incorporated (CORT - Free Report) announced encouraging efficacy data from a phase I/II study on Korlym (mifepristone) in patients suffering from metastatic triple-negative breast cancer (TNBC). Data were presented at the San Antonio Breast Cancer Symposium.
Corcept’s year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical-Drugs industry. Specifically, the stock has surged 66.2% so far this year, while the industry tumbled 26.2%.
The open-label study was conducted to evaluate if the addition of Korlym increases the effect of Halaven in patients with TNBC, whose tumors express the glucocorticoid receptor (GR), one of the receptors to which Korlym binds. The study enrolled 21 patients with GR-positive tumors, one with a GR-negative tumor and one with an unknown GR status. Out of these patients, 4 patients showed a partial response, defined as a 30% or greater reduction in tumor size, 8 had stable disease and 11 had progressive disease.
While 6 patients maintained progression-free survival (PFS) longer than the upper bound for PFS (15 weeks) in patients receiving Halaven monotherapy in a comparable population, median PFS in the study was 11.1 weeks compared to 7.2 weeks in the Halaven monotherapy study. Meanwhile, the company continues to collect overall survival data.
The latest reported study results are impressive. Per Corcept’s press release, TNBC is a form of solid-tumor cancer with a particularly poor prognosis. About 40,000 women are diagnosed with the disease each year and more than 75% of these women’s tumor cells are estimated to express GR.
Currently, there is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed TNBC patients, representing significant unmet medical need.
We note that Korlym, a first-generation cortisol modulator, is already approved for the once-daily oral treatment of hyperglycemia secondary to endogenous Cushing's syndrome in adult patients with glucose intolerance or diabetes mellitus type II who have failed surgery or are not candidates for surgery. A potential label expansion of the drug will boost its sales.
Meanwhile, the University of Chicago is conducting a phase II study on Korlym, in combination with Celgene Corporation’s Abraxane, for the treatment of advanced TNBC. It is also conducting a phase II study on Korlym, in combination with Xtandi, for the treatment of castration-resistant prostate cancer.
Meanwhile, Corcept continues to progress with its oncology program. A phase I/II study on CORT125134 is currently underway. Next year, the company plans to study the candidate’s efficacy, in combination with Abraxane, for the treatment of TNBC and ovarian cancer.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 71% year to date.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
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Corcept Korlym Positive in Phase I/II Breast Cancer Study
Corcept Therapeutics Incorporated (CORT - Free Report) announced encouraging efficacy data from a phase I/II study on Korlym (mifepristone) in patients suffering from metastatic triple-negative breast cancer (TNBC). Data were presented at the San Antonio Breast Cancer Symposium.
Corcept’s year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical-Drugs industry. Specifically, the stock has surged 66.2% so far this year, while the industry tumbled 26.2%.
The open-label study was conducted to evaluate if the addition of Korlym increases the effect of Halaven in patients with TNBC, whose tumors express the glucocorticoid receptor (GR), one of the receptors to which Korlym binds. The study enrolled 21 patients with GR-positive tumors, one with a GR-negative tumor and one with an unknown GR status. Out of these patients, 4 patients showed a partial response, defined as a 30% or greater reduction in tumor size, 8 had stable disease and 11 had progressive disease.
While 6 patients maintained progression-free survival (PFS) longer than the upper bound for PFS (15 weeks) in patients receiving Halaven monotherapy in a comparable population, median PFS in the study was 11.1 weeks compared to 7.2 weeks in the Halaven monotherapy study. Meanwhile, the company continues to collect overall survival data.
The latest reported study results are impressive. Per Corcept’s press release, TNBC is a form of solid-tumor cancer with a particularly poor prognosis. About 40,000 women are diagnosed with the disease each year and more than 75% of these women’s tumor cells are estimated to express GR.
Currently, there is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed TNBC patients, representing significant unmet medical need.
We note that Korlym, a first-generation cortisol modulator, is already approved for the once-daily oral treatment of hyperglycemia secondary to endogenous Cushing's syndrome in adult patients with glucose intolerance or diabetes mellitus type II who have failed surgery or are not candidates for surgery. A potential label expansion of the drug will boost its sales.
Meanwhile, the University of Chicago is conducting a phase II study on Korlym, in combination with Celgene Corporation’s Abraxane, for the treatment of advanced TNBC. It is also conducting a phase II study on Korlym, in combination with Xtandi, for the treatment of castration-resistant prostate cancer.
Meanwhile, Corcept continues to progress with its oncology program. A phase I/II study on CORT125134 is currently underway. Next year, the company plans to study the candidate’s efficacy, in combination with Abraxane, for the treatment of TNBC and ovarian cancer.
Corcept currently carries a Zacks Rank #3 (Hold).
CORCEPT THERAPT Price and Consensus
CORCEPT THERAPT Price and Consensus | CORCEPT THERAPT Quote
Key Picks in the Sector
A couple of better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 71% year to date.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>