Merck Begins Phase 3 Trial Of MK-1084 As First-Line Treatment Of Certain Metastatic NSCLC Patients

RTTNews | 267 days ago
Merck Begins Phase 3 Trial Of MK-1084 As First-Line Treatment Of Certain Metastatic NSCLC Patients

(RTTNews) - Merck & Co. Inc. (MRK), known as MSD outside of the U.S. and Canada, announced Thursday it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutations and express PD-L1.

Merck has initiated a Phase 3, randomized, double-blind, multicenter clinical trial (NCT06345729) evaluating once daily MK-1084 in combination with KEYTRUDA administered once every three weeks compared with KEYTRUDA plus placebo.

The trial will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival, and key secondary endpoints include objective response rate and duration of response.

MK-1084 is being developed through a collaboration with Taiho Pharmaceutical Co. Ltd and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. This collaboration was announced in January 2020.

read more
Merck Q2 Results Top Estimates, But Slashes FY24 Earnings Outlook

Merck Q2 Results Top Estimates, But Slashes FY24 Earnings Outlook

Biopharmaceutical company Merck & Co., Inc. (MRK) reported Tuesday a net profit for the second quarter compared to a loss last year, reflecting improved gross margins and a 7 percent sales growth. Both adjusted earnings per share and quarterly sales topped analysts' estimates. However, the company slashed its adjusted earnings guidance for the full-year 2024.
RTTNews | 150 days ago
Ligand Says Merck Receives FDA Approval For CAPVAXIVE For Adults

Ligand Says Merck Receives FDA Approval For CAPVAXIVE For Adults

Ligand Pharmaceuticals Inc. (LGND) announced Tuesday that its collaborator Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, has received approval from the U.S. Food and Drug Administration (FDA) for CAPVAXIVE, previously known as V116, a 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population.
RTTNews | 192 days ago
Merck Says Health Canada Oks KEYTRUDA In Combination With Trastuzumab And Chemotherapy

Merck Says Health Canada Oks KEYTRUDA In Combination With Trastuzumab And Chemotherapy

Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, announced Monday that Health Canada has granted approval of KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 as determined by a validated test.
RTTNews | 319 days ago
Merck Guides FY24 EPS Above Estimates As Q4 Results Top Estimates

Merck Guides FY24 EPS Above Estimates As Q4 Results Top Estimates

Biopharmaceutical company Merck reported Thursday a net loss for the fourth quarter compared to a profit last year, hurt by hefty charge, despite 6 percent sales growth. However, both adjusted earnings per share and quarterly sales topped analysts' estimates.
RTTNews | 330 days ago
Merck Q4 Results Top Estimates; Guides FY24 Adj. EPS Above Estimates

Merck Q4 Results Top Estimates; Guides FY24 Adj. EPS Above Estimates

Biopharmaceutical company Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, reported Thursday a net loss attributable to the company for the fourth quarter of $1.23 billion or $0.48 per share, compared to net income of $3.02 billion or $1.18 per share in the prior-year quarter.
RTTNews | 330 days ago
Merck, Daiichi Sankyo Say FDA Grants Priority Review In U.S. For Patritumab Deruxtecan

Merck, Daiichi Sankyo Say FDA Grants Priority Review In U.S. For Patritumab Deruxtecan

Merck & Co. Inc. (MRK) and Japan's Daiichi Sankyo Co. Ltd. (DSKYF.PK) announced Friday that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
RTTNews | 371 days ago
Merck Says Phase 3 LEAP-001 Trial Evaluating KEYTRUDA Plus LENVIMA Did Not Meet Endpoints

Merck Says Phase 3 LEAP-001 Trial Evaluating KEYTRUDA Plus LENVIMA Did Not Meet Endpoints

Merck & Co., Inc. (MRK), known as MSD outside of the U.S. and Canada, and Japan's Eisai Co. Ltd. (ESALY.PK, ESALF.PK) announced Friday that the Phase 3 LEAP-001 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.
RTTNews | 385 days ago