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GSK's Jemperli Effective Against First-Line Endometrial Cancer
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GSK plc (GSK - Free Report) announced positive interim data from part 1 of the phase III RUBY study which evaluated Jemperli (dostarlimab) in first-line endometrial cancer.
Part 1 of the RUBY study evaluated Jemperli plus standard-of-care chemotherapy followed by Jemperli compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer. The primary endpoint of part 1 of the study is progression-free survival (PFS) defined by RECIST v1.1 and overall survival (OS)
Data from the study showed that treatment with Jemperli led to a 72% and 36% reduction in the risk of disease progression or death observed in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) population and overall patient population, respectively. Treatment with Jemperli also led to clinically meaningful OS trends.
Based on these results, GSK will initiate regulatory submissions for Jemperli in the first-line endometrial cancer in first-half 2023. Jemperli is already approved by the FDA to treat adult patients with dMMR recurrent or advanced endometrial cancer and solid tumors.
Shares of GSK have declined 0.3% compared with the industry’s 5.9% fall.
Image Source: Zacks Investment Research
Part 2 of the RUBY study is currently ongoing which is evaluating Jemperli plus standard of care chemotherapy followed by Jemperli plus Zejula, compared to placebo plus chemotherapy followed by placebo. The primary endpoint of part 2 of the study is investigator-assessed PFS.
Jemperli was developed by GSK in collaboration with AnaptysBio (ANAB - Free Report) . GSK and AnaptysBio entered into an agreement in 2014 to develop therapies targeting immuno-oncology indications. Per the terms of the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
GSK’s Jemperli is one of the most recently approved PD-1 inhibitors available in the market. The drug faces stiff competition from Merck’s (MRK - Free Report) blockbuster PD-1/PD-L1 inhibitor drug Keytruda. A key revenue generator for Merck, Keytruda is approved for treating many cancer indications globally.
Merck also announced positive data from the late-stage NRG-GY018 study, which evaluated Keytruda plus standard-of-care chemotherapy followed by Keytruda alone, in first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma, whose cancer was either dMMR or mismatch repair proficient (pMMR). Data from the study showed that participants treated with Merck’s Keytruda reduced the risk of progression or death by 70% and 46% in dMMR and pMMR populations, respectively.
In the past 60 days, estimates for Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 48.4% in the year-to-date period.
Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’searnings beat estimates by 14.29%.
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GSK's Jemperli Effective Against First-Line Endometrial Cancer
GSK plc (GSK - Free Report) announced positive interim data from part 1 of the phase III RUBY study which evaluated Jemperli (dostarlimab) in first-line endometrial cancer.
Part 1 of the RUBY study evaluated Jemperli plus standard-of-care chemotherapy followed by Jemperli compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer. The primary endpoint of part 1 of the study is progression-free survival (PFS) defined by RECIST v1.1 and overall survival (OS)
Data from the study showed that treatment with Jemperli led to a 72% and 36% reduction in the risk of disease progression or death observed in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) population and overall patient population, respectively. Treatment with Jemperli also led to clinically meaningful OS trends.
Based on these results, GSK will initiate regulatory submissions for Jemperli in the first-line endometrial cancer in first-half 2023. Jemperli is already approved by the FDA to treat adult patients with dMMR recurrent or advanced endometrial cancer and solid tumors.
Shares of GSK have declined 0.3% compared with the industry’s 5.9% fall.
Image Source: Zacks Investment Research
Part 2 of the RUBY study is currently ongoing which is evaluating Jemperli plus standard of care chemotherapy followed by Jemperli plus Zejula, compared to placebo plus chemotherapy followed by placebo. The primary endpoint of part 2 of the study is investigator-assessed PFS.
Jemperli was developed by GSK in collaboration with AnaptysBio (ANAB - Free Report) . GSK and AnaptysBio entered into an agreement in 2014 to develop therapies targeting immuno-oncology indications. Per the terms of the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
GSK’s Jemperli is one of the most recently approved PD-1 inhibitors available in the market. The drug faces stiff competition from Merck’s (MRK - Free Report) blockbuster PD-1/PD-L1 inhibitor drug Keytruda. A key revenue generator for Merck, Keytruda is approved for treating many cancer indications globally.
Merck also announced positive data from the late-stage NRG-GY018 study, which evaluated Keytruda plus standard-of-care chemotherapy followed by Keytruda alone, in first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma, whose cancer was either dMMR or mismatch repair proficient (pMMR). Data from the study showed that participants treated with Merck’s Keytruda reduced the risk of progression or death by 70% and 46% in dMMR and pMMR populations, respectively.
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Zacks Rank & Stock to Consider
GSK currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Certara (CERT - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 48.4% in the year-to-date period.
Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’searnings beat estimates by 14.29%.