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Merck (MRK) Stops Keytruda-Lynparza Combo Prostate Cancer Study
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Merck (MRK - Free Report) has decided to stop the phase III study — KEYLYNK-010 — evaluating its anti-PD-1 drug, Keytruda, in combination with a partnered PARP inhibitor drug, AstraZeneca’s (AZN - Free Report) Lynparza, as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC). The study included mCRPC patients whose disease progressed following treatment with chemotherapy and either abiraterone acetate or Pfizer’s (PFE - Free Report) Xtandi (enzalutamide).
Please note that Pfizer received initial FDA approval for Xtandi in 2012. Pfizer’s drug is approved as a treatment for CRPC and metastatic castration-sensitive prostate cancer.
The decision to discontinue the KEYLYNK-010 study was taken by Merck following a recommendation from an independent data monitoring committee (DMC) based on the negative outcome from a planned interim analysis. Data from the interim analysis demonstrated that the combination of Keytruda and AstraZeneca’s Lynparza failed to achieve any benefit in overall survival (“OS”) compared to the control arm of either abiraterone acetate or Pfizer’s Xtandi.
Data from an earlier interim analysis had shown that Keytruda plus AstraZeneca’s Lynparza also failed to demonstrate an improvement in radiographic progression free survival (rPFS) compared to the control arm.
The OS and rPFS were KEYLYNK-010 study’s dual primary endpoints and the Keytruda-Lynparza combo failed to provide any benefit in both.
Merck will present data from this study at a future scientific congress.
Merck’s stock has risen 2.6% so far this year against a decrease of 1.9% for the industry.
Image Source: Zacks Investment Research
Merck has several ongoing programs, which are evaluating Keytruda as monotherapy or in combination with other anti-cancer therapies, including AstraZeneca’s Lynparza, for treating prostate cancer. Merck and AstraZeneca are also evaluating the Keytruda and Lynparza combination regimen for advanced lung cancer, ovarian cancer, and triple-negative breast cancer, as well as across solid tumors.
Keytruda is already approved for several settings in the metastatic NSCLC indication. Merck is continuously growing and expanding the drug’s label to include new indications and treatment settings as well as expanding its access globally. The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1600 studies, including nearly 1200 combination studies.
Innoviva’s stock has risen 54.7% so far this year. Estimates for Innoviva’s earnings have gone up from $1.61 to $1.94 for 2022 and from $1.47 to $1.88 for 2023 over the past 60 days.
Innoviva’s earnings performance has been encouraging, with the company exceeding earnings expectations in all the last four quarters. INVA has a four-quarter earnings surprise of 2213.45%, on average.
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Merck (MRK) Stops Keytruda-Lynparza Combo Prostate Cancer Study
Merck (MRK - Free Report) has decided to stop the phase III study — KEYLYNK-010 — evaluating its anti-PD-1 drug, Keytruda, in combination with a partnered PARP inhibitor drug, AstraZeneca’s (AZN - Free Report) Lynparza, as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC). The study included mCRPC patients whose disease progressed following treatment with chemotherapy and either abiraterone acetate or Pfizer’s (PFE - Free Report) Xtandi (enzalutamide).
Please note that Pfizer received initial FDA approval for Xtandi in 2012. Pfizer’s drug is approved as a treatment for CRPC and metastatic castration-sensitive prostate cancer.
The decision to discontinue the KEYLYNK-010 study was taken by Merck following a recommendation from an independent data monitoring committee (DMC) based on the negative outcome from a planned interim analysis. Data from the interim analysis demonstrated that the combination of Keytruda and AstraZeneca’s Lynparza failed to achieve any benefit in overall survival (“OS”) compared to the control arm of either abiraterone acetate or Pfizer’s Xtandi.
Data from an earlier interim analysis had shown that Keytruda plus AstraZeneca’s Lynparza also failed to demonstrate an improvement in radiographic progression free survival (rPFS) compared to the control arm.
The OS and rPFS were KEYLYNK-010 study’s dual primary endpoints and the Keytruda-Lynparza combo failed to provide any benefit in both.
Merck will present data from this study at a future scientific congress.
Merck’s stock has risen 2.6% so far this year against a decrease of 1.9% for the industry.
Image Source: Zacks Investment Research
Merck has several ongoing programs, which are evaluating Keytruda as monotherapy or in combination with other anti-cancer therapies, including AstraZeneca’s Lynparza, for treating prostate cancer. Merck and AstraZeneca are also evaluating the Keytruda and Lynparza combination regimen for advanced lung cancer, ovarian cancer, and triple-negative breast cancer, as well as across solid tumors.
Keytruda is already approved for several settings in the metastatic NSCLC indication. Merck is continuously growing and expanding the drug’s label to include new indications and treatment settings as well as expanding its access globally. The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1600 studies, including nearly 1200 combination studies.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank & Stock to Consider
Innoviva (INVA - Free Report) is better-ranked pharma stock, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’s stock has risen 54.7% so far this year. Estimates for Innoviva’s earnings have gone up from $1.61 to $1.94 for 2022 and from $1.47 to $1.88 for 2023 over the past 60 days.
Innoviva’s earnings performance has been encouraging, with the company exceeding earnings expectations in all the last four quarters. INVA has a four-quarter earnings surprise of 2213.45%, on average.