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Merck (MRK) Begins Phase III NSCLC Study on KRAS Candidate
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Merck (MRK - Free Report) has initiated phase III study on its oral KRAS G12C inhibitor candidate, MK-1084, for first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC).
The study will evaluate MK-1084 in combination with Merck’s blockbuster PD-L1 inhibitor Keytruda in patients with metastatic NSCLC whose tumors harbor KRAS G12C mutations and express PD-L1 (tumor proportion score [TPS] ≥50%). In some early studies, MK-1084, in combination with Keytruda, has demonstrated some promising anti-tumor activity,
The study will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival while some key secondary endpoints are objective response rate and duration of response.
MK-1084 is currently being evaluated in a phase I study as a monotherapy as well as in combination with other therapies for KRAS G12C mutant advanced solid tumors.
Merck’s stock has risen 13.6% in the past year compared with an increase of 3.7% for the industry.
Image Source: Zacks Investment Research
Tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy. KRAS is a well-validated oncology target. KRAS G12C is the most common KRAS mutation in NSCLC. KRAS inhibitors are developed to inhibit KRAS mutations and can address an area of significant unmet medical need for the treatment of cancer.
Some FDA-approved KRAS drugs are Bristol-Myers’ (BMY - Free Report) Krazati and Amgen’s (AMGN - Free Report) Lumakras for KRASG12C-mutated locally advanced or metastatic NSCLC. Krazati was added to Bristol-Myers’ portfolio with the acquisition of Mirati Therapeutics earlier this year.
Amgen’s Lumakras is also being investigated in previously treated KRAS G12C-mutated colorectal cancer as monotherapy and in combination with other therapies. Lumakras is in phase I and phase II development for earlier lines of NSCLC as monotherapy and in combination with other therapies.
Bristol-Myers’ Krazati is further being evaluated in multiple label expansion studies, both as monotherapy and in combination with other drugs, across multiple cancer indications.
Jazz Pharmaceuticals (JAZZ - Free Report) entered into a definitive agreement with U.K.-based biotech Redx Pharma in February 2024 to acquire global rights to the latter’s preclinical KRAS inhibitor program. Jazz and Redx will jointly advance the investigational new drug (IND)-enabling activities for the candidates under this collaboration. However, Jazz will be solely responsible for all clinical development, regulatory and commercialization activities for these candidates.
Image: Bigstock
Merck (MRK) Begins Phase III NSCLC Study on KRAS Candidate
Merck (MRK - Free Report) has initiated phase III study on its oral KRAS G12C inhibitor candidate, MK-1084, for first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC).
The study will evaluate MK-1084 in combination with Merck’s blockbuster PD-L1 inhibitor Keytruda in patients with metastatic NSCLC whose tumors harbor KRAS G12C mutations and express PD-L1 (tumor proportion score [TPS] ≥50%). In some early studies, MK-1084, in combination with Keytruda, has demonstrated some promising anti-tumor activity,
The study will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival while some key secondary endpoints are objective response rate and duration of response.
MK-1084 is currently being evaluated in a phase I study as a monotherapy as well as in combination with other therapies for KRAS G12C mutant advanced solid tumors.
Merck’s stock has risen 13.6% in the past year compared with an increase of 3.7% for the industry.
Image Source: Zacks Investment Research
Tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy. KRAS is a well-validated oncology target. KRAS G12C is the most common KRAS mutation in NSCLC. KRAS inhibitors are developed to inhibit KRAS mutations and can address an area of significant unmet medical need for the treatment of cancer.
Some FDA-approved KRAS drugs are Bristol-Myers’ (BMY - Free Report) Krazati and Amgen’s (AMGN - Free Report) Lumakras for KRASG12C-mutated locally advanced or metastatic NSCLC. Krazati was added to Bristol-Myers’ portfolio with the acquisition of Mirati Therapeutics earlier this year.
Amgen’s Lumakras is also being investigated in previously treated KRAS G12C-mutated colorectal cancer as monotherapy and in combination with other therapies. Lumakras is in phase I and phase II development for earlier lines of NSCLC as monotherapy and in combination with other therapies.
Bristol-Myers’ Krazati is further being evaluated in multiple label expansion studies, both as monotherapy and in combination with other drugs, across multiple cancer indications.
Jazz Pharmaceuticals (JAZZ - Free Report) entered into a definitive agreement with U.K.-based biotech Redx Pharma in February 2024 to acquire global rights to the latter’s preclinical KRAS inhibitor program. Jazz and Redx will jointly advance the investigational new drug (IND)-enabling activities for the candidates under this collaboration. However, Jazz will be solely responsible for all clinical development, regulatory and commercialization activities for these candidates.
Merck has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank stocks here.
Merck & Co., Inc. Price and Consensus
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