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Immunogen Ovarian Cancer Drug Fails in Phase III, Stock Sinks
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Shares of ImmunoGen, Inc. fell almost 47% after its ovarian cancer candidatefailed to meet the primary endpoint of progression-free survival (PFS)in a phase III study. The FORWARD 1 study evaluated the efficacy of mirvetuximab soravtansine as a single-agent therapy compared to chemotherapy for the treatment of patients with platinum-resistant ovarian cancer whose tumors express high or medium levels of FR alpha and who have received up to three prior treatment regimens.
The study did not meet the primary endpoint of PFS in the entire study population as well as the pre-specified subset of patients with high FRα expression.
Shares of the company have declined 78.1% in the past year compared with the industry’s decline of 16.3%.
Although the study did show that in the entire study population, the confirmed overall response rate was higher for mirvetuximab soravtansine than for chemotherapy, there was no significant difference in PFS.
The overall response rate for the company's treatment was higher than the study in which patients were treated with chemotherapy. However, there was no significant difference in overall survival rates.
The company will further assess data from the FORWARD I study to determine potential future steps with a monotherapy approach.
Further, the company said that mirvetuximab combination regimens will continue to be evaluated in ongoing studies as an independent path forward to support a registration in ovarian cancer. Combination regimens with mirvetuximab soravtansine in ovarian cancer are being evaluated in the phase Ib/II FORWARD II study.
The FORWARD II study consists of cohorts assessing mirvetuximab soravtansine in combination with Roche’s (RHHBY - Free Report) Avastin and Merck’s (MRK - Free Report) Keytruda. Preliminary data presented in October 2018 showed that mirvetuximab soravtansine in combination with Keytruda achieved encouraging anti-tumor activity, especially in patients with medium or high FRα expression levels.
In June 2018, the FDA granted Fast Track designation to mirvetuximab soravtansine asa single-agent therapy for the treatment of patients with platinum-resistant ovarian cancer whose tumors express high or medium levels of FRα and who have received up to three prior treatment regimens. Mirvetuximab soravtansine enjoys Orphan Drug status in both the United States and EU for the treatment of ovarian cancer.
Celgene’s earnings per share estimates have increased from $10.21 to $10.75 for 2019 and from $11.63 to $12.70 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average of 2.65%.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, wouldn't you like to know about our 10 finest buy-and-holds for the year?
From more than 4,000 companies covered by the Zacks Rank, these 10 were picked by a process that consistently beats the market. Even during 2018 while the market dropped -5.2%, our Top 10s were up well into double-digits. And during bullish 2012 – 2017, they soared far above the market's +126.3%, reaching +181.9%.
This year, the portfolio features a player that thrives on volatility, an AI comer, and a dynamic tech company that helps doctors deliver better patient outcomes at lower costs.
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Immunogen Ovarian Cancer Drug Fails in Phase III, Stock Sinks
Shares of ImmunoGen, Inc. fell almost 47% after its ovarian cancer candidatefailed to meet the primary endpoint of progression-free survival (PFS)in a phase III study. The FORWARD 1 study evaluated the efficacy of mirvetuximab soravtansine as a single-agent therapy compared to chemotherapy for the treatment of patients with platinum-resistant ovarian cancer whose tumors express high or medium levels of FR alpha and who have received up to three prior treatment regimens.
The study did not meet the primary endpoint of PFS in the entire study population as well as the pre-specified subset of patients with high FRα expression.
Shares of the company have declined 78.1% in the past year compared with the industry’s decline of 16.3%.
Although the study did show that in the entire study population, the confirmed overall response rate was higher for mirvetuximab soravtansine than for chemotherapy, there was no significant difference in PFS.
The overall response rate for the company's treatment was higher than the study in which patients were treated with chemotherapy. However, there was no significant difference in overall survival rates.
The company will further assess data from the FORWARD I study to determine potential future steps with a monotherapy approach.
Further, the company said that mirvetuximab combination regimens will continue to be evaluated in ongoing studies as an independent path forward to support a registration in ovarian cancer. Combination regimens with mirvetuximab soravtansine in ovarian cancer are being evaluated in the phase Ib/II FORWARD II study.
The FORWARD II study consists of cohorts assessing mirvetuximab soravtansine in combination with Roche’s (RHHBY - Free Report) Avastin and Merck’s (MRK - Free Report) Keytruda. Preliminary data presented in October 2018 showed that mirvetuximab soravtansine in combination with Keytruda achieved encouraging anti-tumor activity, especially in patients with medium or high FRα expression levels.
In June 2018, the FDA granted Fast Track designation to mirvetuximab soravtansine asa single-agent therapy for the treatment of patients with platinum-resistant ovarian cancer whose tumors express high or medium levels of FRα and who have received up to three prior treatment regimens. Mirvetuximab soravtansine enjoys Orphan Drug status in both the United States and EU for the treatment of ovarian cancer.
ImmunoGen, Inc. Price
ImmunoGen, Inc. Price | ImmunoGen, Inc. Quote
Zacks Rank and Stocks to Consider
Immunogen currently carries a Zacks Rank#3 (Hold).
A better-ranked stock is Celgene Corp. , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings per share estimates have increased from $10.21 to $10.75 for 2019 and from $11.63 to $12.70 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average of 2.65%.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, wouldn't you like to know about our 10 finest buy-and-holds for the year?
From more than 4,000 companies covered by the Zacks Rank, these 10 were picked by a process that consistently beats the market. Even during 2018 while the market dropped -5.2%, our Top 10s were up well into double-digits. And during bullish 2012 – 2017, they soared far above the market's +126.3%, reaching +181.9%.
This year, the portfolio features a player that thrives on volatility, an AI comer, and a dynamic tech company that helps doctors deliver better patient outcomes at lower costs.
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