Sponsor: Merck Sharp & Dohme LLC (industry)
Phase: 3
Start date: May 24, 2024
Planned enrollment: 600
Last updated in HealthScout: Nov 2024
MK-1084 is an investigational oral inhibitor targeting the KRAS G12C mutation, a prevalent alteration in various cancers, notably non-small cell lung cancer (NSCLC). (cancernetwork.com)
MK-1084 selectively binds to the KRAS G12C protein in its inactive GDP-bound state, preventing its activation and subsequent downstream signaling pathways that promote tumor growth. (targetedonc.com)
In a phase 1 trial, MK-1084 demonstrated promising efficacy:
Monotherapy: Among 55 patients with previously treated solid tumors harboring KRAS G12C mutations, MK-1084 achieved an objective response rate (ORR) of 29% and a disease control rate (DCR) of 82%. (onclive.com)
Combination Therapy: In 27 treatment-naïve NSCLC patients with PD-L1 expression ≥1%, MK-1084 combined with pembrolizumab resulted in an ORR of 70% and a DCR of 85%. (onclive.com)
MK-1084 exhibited an acceptable safety profile:
Monotherapy: Treatment-related adverse events (TRAEs) occurred in 60% of patients, with 7% experiencing grade 3 and 2% grade 4 TRAEs. No dose-limiting toxicities (DLTs) were observed. (onclive.com)
Combination Therapy: In the combination arm, 87% of patients experienced TRAEs, including 39% with grade 3 and 3% with grade 4 events. One patient experienced DLTs characterized by grade 3 elevations in liver enzymes. (onclive.com)
Pembrolizumab/MK-1084 Combo Is the Focus of Phase 3 Trial in KRAS G12C+ Metastatic NSCLC
Preliminary Data of MK-1084 +/- Pembrolizumab in Solid Tumors and NSCLC
Last updated: Apr 2025
Merck has initiated a Phase 3 clinical trial (NCT06345729) to evaluate the combination of MK-1084, an investigational oral KRAS G12C inhibitor, with pembrolizumab (Keytruda) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations and expressing PD-L1 with a tumor proportion score (TPS) of 50% or higher. (stocktitan.net)
Preliminary results from a Phase 1 study presented at the European Society for Medical Oncology (ESMO) Congress in 2023 demonstrated that MK-1084, both as a monotherapy and in combination with pembrolizumab, exhibited a manageable safety profile and promising antitumor activity in patients with advanced solid tumors harboring KRAS G12C mutations. (stocktitan.net)
In the monotherapy arm, MK-1084 achieved an objective response rate (ORR) of 22% across all doses and tumor types during dose escalation, with a median follow-up of 8.1 months. Notably, there were no deaths or grade 5 treatment-related adverse events reported. (fiercebiotech.com)
In the combination arm with pembrolizumab, patients with previously untreated metastatic NSCLC experienced an ORR of 71% after a median follow-up of 5.2 months. This combination was described as having a "manageable safety profile and promising anti-tumor activity." (stocktitan.net)
The initiation of this Phase 3 trial is significant due to the prevalence of KRAS G12C mutations in NSCLC and the limited treatment options available for this patient population. Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, stated, "Based on early evidence showing MK-1084 in combination with Keytruda had a manageable safety profile and promising anti-tumor activity, we are now proceeding to a larger Phase 3 trial to evaluate this combination in certain patients with metastatic non-small cell lung cancer." (stocktitan.net)
For oncologists and patients considering participation, the trial's design as a randomized, double-blind, multicenter study aims to provide robust data on the efficacy and safety of the MK-1084 and pembrolizumab combination. The primary endpoints include progression-free survival and overall survival, with key secondary endpoints such as objective response rate and duration of response. The trial plans to enroll approximately 600 patients globally, reflecting a substantial commitment to evaluating this combination therapy. (stocktitan.net)
Last updated: Apr 2025
Goal: The trial aims to determine whether the combination of the investigational drug MK-1084 with pembrolizumab is more effective than pembrolizumab with a placebo in improving progression-free survival (PFS) and overall survival (OS) in patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC) exhibiting a PD-L1 TPS of ≥50%.
Patients: The study targets patients newly diagnosed with stage IV NSCLC characterized by the KRAS G12C mutation and a PD-L1 tumor proportion score of at least 50%. Eligible patients must meet several criteria, including measurable disease, satisfactory ECOG performance status (0 or 1), and must not have received prior systemic therapy for metastatic NSCLC.
Design: The study is a Phase 3, randomized, double-blind, multicenter trial with a planned enrollment of 600 participants. It is designed to evaluate first-line treatment for patients with specific mutations and PD-L1 expression levels in NSCLC.
Treatments: The trial assesses two treatment regimens. The experimental arm involves MK-1084, a selective KRAS G12C-GDP inhibitor, combined with pembrolizumab. MK-1084 targets the GDP-loaded form of mutant KRAS G12C protein through covalent binding at the cysteine residue in the switch II pocket. In previous Phase 1 trials, MK-1084 in combination with pembrolizumab showed a significant increase in response rates in patients with PD-L1 TPS ≥50%. The comparator arm employs pembrolizumab with a placebo. Pembrolizumab, an anti-PD-1 monoclonal antibody, is administered via intravenous infusion every 21 days.
Outcomes: Primary outcomes include progression-free survival and overall survival. Secondary outcomes range from objective response rate and duration of response to various parameters assessing quality of life using the EORTC QLQ-C30 and LC13 questionnaires, adverse events, and time to deterioration across several quality of life indicators.
Burden on patient: The patient burden is considered moderate. Given that both treatment regimens include IV infusions every 21 days akin to standard care, the trial requires regular central review assessments and evaluations in line with the Response Criteria in Solid Tumors (RECIST). While there are standard imaging studies and quality of life questionnaires involved, the drug profile of MK-1084 may necessitate increased monitoring for adverse events, particularly due to the investigational status. This includes regular blood work and possible supportive care visits, all contributing to a more intensive follow-up schedule compared to existing therapies.
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of NSCLC
* Has newly diagnosed Stage IV NSCLC by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
* Has measurable disease based on RECIST 1.1
* Has provided tumor tissue that demonstrates PD-L1 expression in ≥50% of tumor cells
* Has provided tumor tissue that demonstrates presence of KRAS G12C mutation
* Has life expectancy of at least 3 months
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
* For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 10 days after the last dose of oral intervention: Either be abstinent or must agree to use male condom plus additional contraceptive method.
* For participant assigned female sex at birth: Either be a person of nonchildbearing potential (PONCBP) or must agree to follow contraceptive guidance during the study treatment period and for at least 10 days after the last dose of oral intervention and 120 days after the last dose of pembrolizumab. Must abstain from breastfeeding during the study intervention period and for at least 120 days after study intervention.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
Exclusion Criteria:
* Diagnosis of small cell lung cancer
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
* Has a known history of, or active, neurologic paraneoplastic syndrome
* Has an active infection requiring systemic therapy
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to \>470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
* Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
* Has one or more of the following ophthalmological findings/conditions: intraocular diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease pressure \>21 mm Hg and/or any diagnosis of glaucoma
* Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, or malabsorption)
* Received prior systemic anticancer therapy for their metastatic NSCLC
* Received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor within 12 months before diagnosis of metastatic NSCLC
* Has received radiotherapy within 2 weeks of start of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* History of allogeneic tissue/solid organ transplant
* Has not fully recovered from any effects of major surgical procedure. Surgical procedures that required general anesthesia must be completed at least 2 weeks before first study intervention administration.
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