We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Merck's (MRK) Welireg Meets Renal Cell Carcinoma Study Goals
Read MoreHide Full Article
Merck (MRK - Free Report) reported positive top-line results from an interim analysis of the phase III LITESPARK-005 study evaluating Welireg (belzutifan) in adult patients with advanced renal cell carcinoma (“RCC”) that progressed following treatment with a PD-1/L1 checkpoint inhibitor and VEGF-TKI therapy.
Based on an interim data analysis, the study achieved one of its primary endpoints of progression-free survival (“PFS”). Though a favorable trend was observed in the study’s other primary endpoint of overall survival (“OS”), it did not reach statistical significance. The study investigators will test the OS endpoint at a subsequent analysis.
The LITESPARK-005 study also achieved its secondary endpoint of statistically significant improvement in the objective response rate (“ORR”). No new safety signals were reported in the study, and the safety profile of Welireg was in line with observations in its previously conducted studies.
Merck plans to present these results at a future medical meeting.
An oral HIF-2α inhibitor, Welireg is currently approved in the United States and Europe to treat adult patients with von Hippel-Lindau (“VHL”) disease who require therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.
Merck’s shares have lost 1.6% year to date against the industry’s 7.8% growth.
Image Source: Zacks Investment Research
Per management, the LITESPARK-005 is the first late-stage study to show positive results in patients with advanced RCC who received a checkpoint inhibitor and a VEGF-TKI therapy. With a potential label expansion in advanced RCC, Merck aims to introduce Welireg as a new treatment option that can reduce the risk of disease progression or death for an indication with low survival rates.
The LITESPARK-005 study is part of Merck's comprehensive late-stage development program on Welireg in RCC. The program consists of three other late-stage studies – LITESPARK-011, LITESPARK-012 and LITESPARK-022. While LITESPARK-011 and LITESPARK-012 evaluate Welireg in the second-line and treatment-naïve advanced disease settings, respectively, LITESPARK-022 evaluates Welireg in the adjuvant setting.
Merck’s oncology portfolio is highly dependent on Keytruda, its blockbuster anti-PD-1 therapy, which accounted for over 40% of the company’s revenues in second-quarter 2022. With concerns over Keytruda’s potential loss of exclusivity post-2028, a label expansion to drugs like Welireg will enable the company to narrow down its dependence on the anti-PD-1 therapy.
Merck currently carries a Zacks Rank #3 (Hold). Some other top-ranked stocks in the overall healthcare sector include Eton Pharmaceuticals (ETON - Free Report) , Johnson & Johnson (JNJ - Free Report) and Pieris Pharmaceuticals (PIRS - Free Report) . While Eton and Pieris sport a Zacks Rank #1 (Strong Buy), J&J carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Eton Pharmaceuticals’ 2023 loss per share have narrowed from 31 cents to 10 cents. During the same period, the earnings per share estimates for 2024 have risen from 9 cents to 26 cents. Year to date, shares of ETON have surged 65.3%.
Earnings of Eton Pharmaceuticals beat estimates in each of the last four quarters, witnessing an earnings surprise of 162.14% on average. In the last reported quarter, Eton’s earnings beat estimates by 300.00%.
In the past 30 days, estimates for Pieris Pharmaceuticals’ 2023 loss per share have narrowed from 68 cents to 35 cents. During the same period, the loss estimates per share for 2024 have improved from 67 cents to 41 cents. Year to date, shares of PIRS have lost 72.8%.
Earnings of Pieris Pharmaceuticals beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 34.20% on average. In the last reported quarter, Pieris’ earnings beat estimates by 131.25%.
In the past 60 days, estimates for J&J’s 2023 earnings per share have increased from $10.65 to $10.75. During the same period, the earnings estimates per share for 2024 have risen from $11.12 to $11.29. Shares of J&J are down 2.4% in the year-to-date period.
Earnings of J&J beat estimates in each of the last four quarters, witnessing an average surprise of 5.58%. In the last reported quarter, J&J’s earnings beat estimates by 7.28%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Shutterstock
Merck's (MRK) Welireg Meets Renal Cell Carcinoma Study Goals
Merck (MRK - Free Report) reported positive top-line results from an interim analysis of the phase III LITESPARK-005 study evaluating Welireg (belzutifan) in adult patients with advanced renal cell carcinoma (“RCC”) that progressed following treatment with a PD-1/L1 checkpoint inhibitor and VEGF-TKI therapy.
Based on an interim data analysis, the study achieved one of its primary endpoints of progression-free survival (“PFS”). Though a favorable trend was observed in the study’s other primary endpoint of overall survival (“OS”), it did not reach statistical significance. The study investigators will test the OS endpoint at a subsequent analysis.
The LITESPARK-005 study also achieved its secondary endpoint of statistically significant improvement in the objective response rate (“ORR”). No new safety signals were reported in the study, and the safety profile of Welireg was in line with observations in its previously conducted studies.
Merck plans to present these results at a future medical meeting.
An oral HIF-2α inhibitor, Welireg is currently approved in the United States and Europe to treat adult patients with von Hippel-Lindau (“VHL”) disease who require therapy for associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.
Merck’s shares have lost 1.6% year to date against the industry’s 7.8% growth.
Image Source: Zacks Investment Research
Per management, the LITESPARK-005 is the first late-stage study to show positive results in patients with advanced RCC who received a checkpoint inhibitor and a VEGF-TKI therapy. With a potential label expansion in advanced RCC, Merck aims to introduce Welireg as a new treatment option that can reduce the risk of disease progression or death for an indication with low survival rates.
The LITESPARK-005 study is part of Merck's comprehensive late-stage development program on Welireg in RCC. The program consists of three other late-stage studies – LITESPARK-011, LITESPARK-012 and LITESPARK-022. While LITESPARK-011 and LITESPARK-012 evaluate Welireg in the second-line and treatment-naïve advanced disease settings, respectively, LITESPARK-022 evaluates Welireg in the adjuvant setting.
Merck’s oncology portfolio is highly dependent on Keytruda, its blockbuster anti-PD-1 therapy, which accounted for over 40% of the company’s revenues in second-quarter 2022. With concerns over Keytruda’s potential loss of exclusivity post-2028, a label expansion to drugs like Welireg will enable the company to narrow down its dependence on the anti-PD-1 therapy.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). Some other top-ranked stocks in the overall healthcare sector include Eton Pharmaceuticals (ETON - Free Report) , Johnson & Johnson (JNJ - Free Report) and Pieris Pharmaceuticals (PIRS - Free Report) . While Eton and Pieris sport a Zacks Rank #1 (Strong Buy), J&J carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Eton Pharmaceuticals’ 2023 loss per share have narrowed from 31 cents to 10 cents. During the same period, the earnings per share estimates for 2024 have risen from 9 cents to 26 cents. Year to date, shares of ETON have surged 65.3%.
Earnings of Eton Pharmaceuticals beat estimates in each of the last four quarters, witnessing an earnings surprise of 162.14% on average. In the last reported quarter, Eton’s earnings beat estimates by 300.00%.
In the past 30 days, estimates for Pieris Pharmaceuticals’ 2023 loss per share have narrowed from 68 cents to 35 cents. During the same period, the loss estimates per share for 2024 have improved from 67 cents to 41 cents. Year to date, shares of PIRS have lost 72.8%.
Earnings of Pieris Pharmaceuticals beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 34.20% on average. In the last reported quarter, Pieris’ earnings beat estimates by 131.25%.
In the past 60 days, estimates for J&J’s 2023 earnings per share have increased from $10.65 to $10.75. During the same period, the earnings estimates per share for 2024 have risen from $11.12 to $11.29. Shares of J&J are down 2.4% in the year-to-date period.
Earnings of J&J beat estimates in each of the last four quarters, witnessing an average surprise of 5.58%. In the last reported quarter, J&J’s earnings beat estimates by 7.28%.