MK-3475 SC / Merck (MSD) - LARVOL DELTA

KEYNOTE-603: Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=242 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • TMB

Budget and Time Impact Analysis of Introducing Subcutaneous Pembrolizumab to Patients From Institution HCP and Patient Perspectives in the United States (US) (ISPOR-EU 2025) - "Pembrolizumab with berahyaluronidase alfa for subcutaneous (SC) administration demonstrated noninferior pharmacokinetics compared to pembrolizumab IV with consistent efficacy and safety results reported in the MK3475A-D77 trial. Pembrolizumab SC will enhance the drug administration of immunotherapy for healthcare providers, expecting to improve practice efficiency, mitigate capacity constraints, and save budget. It also provides benefits to patients in administration time saving and potential productivity gain."

Clinical

Model-based dose selection and pharmacokinetic bridging of subcutaneous from intravenous pembrolizumab across indications. (PubMed, Eur J Cancer) - P1, P3 | "These findings confirm pembrolizumab SC 790 mg Q6W and 395 Q3W are appropriate to maintain efficacy and safety similar to pembrolizumab IV across approved indications."

Journal • PK/PD data • Oncology

BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=420 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Time and Motion Study Comparing Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab in Combination with Chemotherapy for the Treatment of Metastatic Non-small Cell Lung Cancer. (PubMed, Adv Ther) - "Pembrolizumab SC substantially reduces active HCP time and patient chair time versus pembrolizumab IV. Time liberated for HCPs could be reallocated toward additional patient care activities, while optimized chair utilization could improve overall healthcare efficiency."

Clinical • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pharmacokinetics and bioavailability of pembrolizumab with berahyaluronidase alfa for subcutaneous administration in participants with advanced or metastatic solid tumors: The phase 1 study 3475A-C18. (PubMed, Eur J Cancer) - P1 | "Results from study 3475A-C18 informed selection of pembrolizumab SC 790 mg Q6W at 165 mg/mL for further clinical development to ensure that all patients have the appropriate pembrolizumab exposure to derive expected clinical benefit. Arm 4 results provided key clinical data supporting the pembrolizumab SC 395 mg Q3W dosing regimen."

Journal • P1 data • PK/PD data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Phase 3 Trial of First-Line MK-3475A (Subcutaneous Pembrolizumab) for Stage IV NSCLC With PD-L1 TPS ≥ 50% (IASLC-WCLC 2025) - P3 | "Introduction : First-line treatment for patients with stage IV non-small-cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) ≥50% and no targetable genetic alterations includes intravenous (IV) administration of the anti-PD-1 monoclonal antibody (mAb) pembrolizumab. Secondary objectives include exposure (cycle 1 maximum concentration [C max ] and C trough , and steady state [cycle 3] C max and AUC 0-6wk ) of pembrolizumab SC vs pembrolizumab IV Q6W, anti-pembrolizumab antibody levels, cycle 1 and steady-state (cycle 3) C trough of pembrolizumab SC vs pembrolizumab IV Q3W, ORR, PFS, and duration of response (each per RECIST v1.1 by blinded independent central review), OS, safety, and pt-reported outcomes. Recruitment is ongoing."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • ROS1

BNT326-02: A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=420 | Not yet recruiting | Sponsor: BioNTech SE

New P1/2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

KEYNOTE-603: Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=242 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Jun 2025 ➔ Aug 2027 | Trial primary completion date: Jun 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Gastric Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • TMB

Subcutaneous Versus Intravenous Pembrolizumab, in Combination With Chemotherapy, for Treatment of Metastatic Non-Small Cell Lung Cancer: The Phase 3 3475A-D77 Trial. (PubMed, Ann Oncol) - P3 | "Overall exposure and trough concentrations of pembrolizumab SC 790 mg Q6W were noninferior to those of pembrolizumab IV 400 mg Q6W given with chemotherapy in participants with treatment-naïve mNSCLC. Results support pembrolizumab SC as a treatment option in all indications where pembrolizumab IV can be used."

Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

ESMO 2024: Treatment of uHCC : Episode 7: LEAP-012 Study Results (OncLive) - "Panelists discuss the findings from the LEAP-012 study, which explores the efficacy of transarterial chemoembolization combined with lenvatinib and pembrolizumab in patients with Child-Pugh class A disease and intermediate-stage hepatocellular carcinoma."

Video

KEYNOTE-603: Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (clinicaltrials.gov) - P1 | N=242 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting | N=108 ➔ 242

Enrollment change • Enrollment open • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • TMB

Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555) (clinicaltrials.gov) - P1 | N=138 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Metastases • Trial completion • Melanoma • Oncology • Solid Tumor • BRAF • TNFRSF9

A Pilot Study of Pembrolizumab and Peptide Receptor Radionuclide Therapy for Patients with Metastatic Well Differentiated Neuroendocrine Tumors (NANETS 2023) - "Preliminary results indicate that combination treatment with 177Lu-DOTATATE PRRT and pembrolizumab is well tolerated and leads to durable disease control in a subset of patients."

Clinical

A Pilot Study of Pembrolizumab and Embolization or 90Y Radioembolization for Patients with Metastatic WellDifferentiated Neuroendocrine Tumors (NANETS 2023) - "Combination therapy with pembrolizumab and TAE or TARE did not lead to abscopal responses in a small group of patients with metastatic WD-NET."

Clinical

Neoadjuvant Vibostolimab Plus Pembrolizumab Demonstrates Activity in Melanoma (Cancer Therapy Advisor) - "These results support further investigation of vibostolimab plus pembrolizumab in the adjuvant and neoadjuvant settings, said study presenter Reinhard Dummer, MD..."

Media quote

Updates in the Treatment of Advanced Renal Cell Carcinoma : Episode 3: 4-Year Follow-Up Results of Lenvatinib Plus Pembrolizumab in Frontline aRCC (Cancer Network) - "Panelists analyze the 4-year follow-up results of the CLEAR study, covering study design, efficacy, safety, and clinical implications."

Video

Highlights in Renal Cell Carcinoma From ASCO 2023 (Medscape) - "Dr Eric Jonasch...highlights from the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. First, Dr Jonasch discusses the CONTACT-03 study, which examined whether adding atezolizumab to cabozantinib would improve outcomes in patients who progressed on immunotherapy. The combination provided no clear benefit and led to increased toxicity."

Video

Panelists Share How CLEAR and KEYNOTE-426 Data Presented at ASCO 2023 Impact Treatment Decisions (YouTube) - "A roundtable discussion, moderated by Brian Rini, MD...focused on treatment considerations for frontline and refractory renal cell carcinoma, including a discussion of new data presented at ASCO 2023. Dr. Rini was joined by a panel that included...Pedro Barata, MD...In the next segment of the roundtable series, the panelists debate the use of IO/IO versus IO/TKI regimens for frontline RCC therapy, reacting to the updated data presented on the lenvatinib/pembrolizumab and axitinib/pembrolizumab combinations."

Video

Long-Term KEYNOTE-426 Data Continue to Support Frontline Pembrolizumab Plus Axitinib as SOC for Advanced ccRCC (OncLive) - '"[These improvements with the combination] are observed despite the high percentage of subsequent therapy [received] in both arms, but especially in the sunitinib arm,' Brian I. Rini, MD...'There was a substantial percentage of patients who made it to that 2-year mark, who completed 35 cycles of pembrolizumab, and they have very good long-term outcomes as you might expect. These data continue to support pembrolizumab plus axitinib as a standard of care for [this population].'"

Media quote

Effectiveness and Cost-Effectiveness Analysis of 11 Treatment Paths, Seven First-Line and Three Second-Line Treatments for Chinese Patients with Advanced Wild-Type Squamous Non-Small Cell Lung Cancer: A Sequential Model (ISPOR 2023) - "A microsimulation-based sequential model was developed to estimate costs and quality-adjusted life years (QALY) for treatment sequences with first-line platinum- and paclitaxel-based chemotherapy (SC) with or without nedaplatin, tislelizumab, camrelizumab, sintilimab, sugalimumab or pembrolizumab, followed by second-line docetaxel, tislelizumab or nivolumab. PED and CAD are the most effective and cost-effective treatment sequence, respectively; pembrolizumab+SC and camrelizumab+SC are the most effective and cost-effective first-line choice, respectively; tislelizumab is the most effective and cost-effective second-line choice."

Clinical • Cost effectiveness • HEOR • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Understanding the Role of Re-irradiation (Cleveland Clinic) - "The feasibility of these approaches depends on many factors, including the type of tumor and location(s) to be treated. For example, patients with head and neck cancers often receive 70 units of radiation for five to seven weeks at initial diagnosis; in the setting of recurrences, reirradiation was studied but often delivered twice daily for several weeks, which is very challenging for patients. However, an ongoing national trial....Shlomo Koyfman, MD is evaluating delivery of five treatments of stereotactic body radiotherapy (SBRT) with or without pembrolizumab for patients with recurrent or second primary head and neck cancers."

Media quote

Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555) (clinicaltrials.gov) - P1 | N=136 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Feb 2023 ➔ Dec 2023 | Trial primary completion date: Feb 2023 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF • TNFRSF9

KEYNOTE-A86: Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86) (clinicaltrials.gov) - P3 | N=512 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1