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

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..."

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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].'"

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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."

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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