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Lilly's Cyramza Shows Survival Benefit in Liver Cancer Study
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Eli Lilly and Company’s (LLY - Free Report) announced that a late-stage study evaluating its already approved cancer drug, Cyramza for the second-line treatment of liver cancer met the primary as well as secondary endpoint.
While the primary endpoint was overall survival (OS) — the percentage of patients who are alive after a certain length of time — the secondary endpoint was progression-free survival (PFS), the amount of time the patients live without their tumors growing larger.
The phase III REACH -2 study evaluated the benefit of Cyramza as a single agent in patients with hepatocellular carcinoma (HCC), also known as liver cancer, who were intolerant to or experienced disease progression after treatment with Bayer (BAYRY - Free Report) /Amgen’s (AMGN - Free Report) Nexavar and also had elevated levels of alpha-fetoprotein (AFP). According to Lilly’s press release, approximately half of all advanced HCC patients have a high AFP, a marker of poor prognosis.
The results from the REACH – 2 study showed that such patients derived a survival benefit with Cyramza treatment following first-line treatment with Nexavar.
Please note that Cyramza is already marketed as a single agent and in combination with another agent as a second-line treatment of advanced or metastatic gastric cancer. It is also approved for use in combination with another agent as a second-line treatment of metastatic non-small cell lung cancer and metastatic colorectal cancer.
Lilly plans to file regulatory applications seeking label expansion of Cyramza for the specified subgroup of liver cancer patient population by mid-2018.
Many cancer drugs are being approved based on progression free survival without evidence of benefit in survival or quality of life. However, OS data, once available, sometimes shows that the drug does not help people live longer. The fact that Cyramza offered an overall survival benefit in the REACH -2 study probably impressed investors, which led the stock to rise 1.4% on Wednesday. However, this year so far, Lilly’s shares have declined 6.2%, comparing unfavorably with the industry’s decrease of 3.1%.
Cyramza generated revenues of $758.3 million in 2017, recording a year-over-year increase of 23%. Meanwhile, Cyramza is being evaluated in several studies for additional indications
Phase III studies of Cyramza in advanced urothelial carcinoma and first-line EGFR mutation positive NSCLC are ongoing. While OS data from urothelial carcinoma study is expected in the first half of the year, PFS data from the EGFR mutation positive NSCLC study is expected to be released in late 2018.
In December, Lilly announced top-line data from a phase III study – RAINFALL – evaluating Cyramza as first-line treatment for patients with advanced gastric cancer. The study met its primary endpoint of PFS but failed to improve OS. Lilly decided not to seek regulatory approval in the first-line setting based on the data from this study.
Another large-cap stock carrying the same Zacks Rank as Lilly is GlaxoSmithKline (GSK - Free Report) .
Glaxo’s stock has returned 14.5% this year so far while earnings estimates for 2018 and 2019 went up 5% and 4.8%, respectively, in the past 60 days.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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Lilly's Cyramza Shows Survival Benefit in Liver Cancer Study
Eli Lilly and Company’s (LLY - Free Report) announced that a late-stage study evaluating its already approved cancer drug, Cyramza for the second-line treatment of liver cancer met the primary as well as secondary endpoint.
While the primary endpoint was overall survival (OS) — the percentage of patients who are alive after a certain length of time — the secondary endpoint was progression-free survival (PFS), the amount of time the patients live without their tumors growing larger.
The phase III REACH -2 study evaluated the benefit of Cyramza as a single agent in patients with hepatocellular carcinoma (HCC), also known as liver cancer, who were intolerant to or experienced disease progression after treatment with Bayer (BAYRY - Free Report) /Amgen’s (AMGN - Free Report) Nexavar and also had elevated levels of alpha-fetoprotein (AFP). According to Lilly’s press release, approximately half of all advanced HCC patients have a high AFP, a marker of poor prognosis.
The results from the REACH – 2 study showed that such patients derived a survival benefit with Cyramza treatment following first-line treatment with Nexavar.
Please note that Cyramza is already marketed as a single agent and in combination with another agent as a second-line treatment of advanced or metastatic gastric cancer. It is also approved for use in combination with another agent as a second-line treatment of metastatic non-small cell lung cancer and metastatic colorectal cancer.
Lilly plans to file regulatory applications seeking label expansion of Cyramza for the specified subgroup of liver cancer patient population by mid-2018.
Many cancer drugs are being approved based on progression free survival without evidence of benefit in survival or quality of life. However, OS data, once available, sometimes shows that the drug does not help people live longer. The fact that Cyramza offered an overall survival benefit in the REACH -2 study probably impressed investors, which led the stock to rise 1.4% on Wednesday. However, this year so far, Lilly’s shares have declined 6.2%, comparing unfavorably with the industry’s decrease of 3.1%.
Cyramza generated revenues of $758.3 million in 2017, recording a year-over-year increase of 23%. Meanwhile, Cyramza is being evaluated in several studies for additional indications
Phase III studies of Cyramza in advanced urothelial carcinoma and first-line EGFR mutation positive NSCLC are ongoing. While OS data from urothelial carcinoma study is expected in the first half of the year, PFS data from the EGFR mutation positive NSCLC study is expected to be released in late 2018.
In December, Lilly announced top-line data from a phase III study – RAINFALL – evaluating Cyramza as first-line treatment for patients with advanced gastric cancer. The study met its primary endpoint of PFS but failed to improve OS. Lilly decided not to seek regulatory approval in the first-line setting based on the data from this study.
Lilly carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Another large-cap stock carrying the same Zacks Rank as Lilly is GlaxoSmithKline (GSK - Free Report) .
Glaxo’s stock has returned 14.5% this year so far while earnings estimates for 2018 and 2019 went up 5% and 4.8%, respectively, in the past 60 days.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>