vibostolimab/pembrolizumab (MK-7684A) / Merck (MSD) - LARVOL DELTA

Vibostolimab coformulated with pembrolizumab versus pembrolizumab alone as adjuvant therapy for high-risk stage IIB to IV melanoma in the phase 3 KEYVIBE-010 trial: results from participants enrolled in China (ESMO Asia 2025) - P3 | "In Chinese pts with resected stage IIB-IV melanoma, adjuvant vibo/pembro did not provide additional clinical benefit vs pembro alone, consistent with the global population. Pembro monotherapy remains a standard of care in this setting."

Clinical • P3 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • TIGIT

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - P2 | N=296 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

VIBOSTOLIMAB AND PEMBROLIZUMAB COFORMULATION COMBINED WITH LENVATINIB FOR MISMATCH REPAIR-PROFICIENT ADVANCED ENDOMETRIAL CANCER: RESULTS FROM COHORT B2 OF THE PHASE 2 KEYVIBE-005 STUDY (IGCS 2025) - P2 | "40 participants received ≥1 dose of treatment (80% received only 1-line prior therapy, any setting [68% prior (neo)adjuvant therapy]). Median follow-up was 41.5 (range, 40.0-45.6) months at data cutoff (August 5, 2025). ORR per investigator was 43% (95% CI, 27%-59%) (Table 1)."

Late-breaking abstract • Metastases • Mismatch repair • P2 data • pMMR • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI • TIGIT

Biomarker analysis of coformulation of vibostolimab with pembrolizumab (vibo/pembro) with or without docetaxel for metastatic non–small-cell lung cancer (mNSCLC) after chemotherapy and immunotherapy (SITC 2025) - P2 | "Additional biomarker data will be presented.Conclusions These biomarker analyses showed that higher TIGIT IHC was associated with numerically longer PFS and OS in participants with mNSCLC previously treated with an anti-PD-(L)1 and platinum-based chemotherapy receiving vibo/pembro with docetaxel; this benefit was not observed with vibo/pembro alone.Trial Registration ClinicalTrials.gov identifier, NCT04725188Ethics Approval The study was conducted in accordance with principles of Good Clinical Practice and approved by the appropriate institutional review boards and regulatory agencies. All participants provided written informed consent before enrolling.Abstract 508 Table 1View inline•Open as popupPFS and OS HRa estimates for biomarker subgroups"

Biomarker • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1 • TIGIT

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) (clinicaltrials.gov) - P3 | N=1594 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

KEYMAKER-U03 sub-study 03A: Triplet investigational combinations of immunotherapy and targeted treatments as first-line therapy for advanced renal cell carcinoma (Eurekalert) - "This sub-study enrolled 353 patients with advanced ccRCC who were randomly assigned to receive one of the following four investigational combinations, or standard treatment, as first-line therapy: Favezelimab-pembrolizumab + lenvatinib; vibostolimab-pembrolizumab + lenvatinib; quavonlimab-pembrolizumab + lenvatinib; pembrolizumab + belzutifan + lenvatinib, or pembrolizumab + lenvatinib....The pembrolizumab-belzutifan-lenvatinib triplet demonstrated promising antitumor activity with an objective response rate (ORR) of 78% and a median progression-free survival (PFS) of 31.8 months as compared to 20.8 months in the reference arm. The pembrolizumab/quavonlimab plus lenvatinib group showed an ORR of 71%, but median PFS was similar to the control arm. The efficacy of the other two combinations was less favorable."

P1/2 data • Clear Cell Renal Cell Carcinoma

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - P2 | N=320 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2030 ➔ Oct 2025 | Trial primary completion date: Aug 2026 ➔ Oct 2025

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) (clinicaltrials.gov) - P3 | N=1594 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2026 ➔ Sep 2025

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) (clinicaltrials.gov) - P3 | N=1594 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2025 ➔ Sep 2026

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Vibostolimab Coformulated with Pembrolizumab in Participants with Docetaxel-pretreated Metastatic Castration-resistant Prostate Cancer: KEYNOTE-365 Cohort G. (PubMed, Eur Urol Focus) - P1/2 | "We found that this combination had limited antitumor activity, with side effects as expected for the two drugs individually. The KEYNOTE-365 trial is registered on ClinicalTrials.gov as NCT02861573."

Journal • Cardiovascular • Castration-Resistant Prostate Cancer • Dermatology • Genito-urinary Cancer • Oncology • Prostate Cancer • Pruritus • Pulmonary Embolism • Respiratory Diseases • Solid Tumor

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) (clinicaltrials.gov) - P2 | N=613 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) (clinicaltrials.gov) - P2 | N=302 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2027 ➔ Apr 2026 | Trial primary completion date: Jun 2026 ➔ May 2025

dMMR • Mismatch repair • MSI-H • Trial completion date • Trial primary completion date • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) (clinicaltrials.gov) - P2 | N=613 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2026 ➔ Aug 2025 | Trial primary completion date: Aug 2026 ➔ Aug 2025

Pan tumor • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) (clinicaltrials.gov) - P3 | N=1594 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Mar 2031 ➔ Aug 2025

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

KEYVIBE-006: Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006) (clinicaltrials.gov) - P3 | N=611 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2029 ➔ Aug 2026 | Trial primary completion date: Sep 2028 ➔ Aug 2026

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003) (clinicaltrials.gov) - P3 | N=1264 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Dec 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2026 ➔ Sep 2024

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-1 • PD-L1 • ROS1

KEYVIBE 007: Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007) (clinicaltrials.gov) - P3 | N=739 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2027 ➔ Jan 2026 | Trial primary completion date: Jun 2026 ➔ Sep 2024

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01) (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Merck Sharp & Dohme LLC | N=60 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Tumor mutational burden • Classical Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Oncology • Pediatrics • Solid Tumor

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006) (clinicaltrials.gov) - P3 | N=784 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - P2 | N=320 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Morgan Stanley: Personalized cancer vaccines and ADCs will become the main catalysts for the tumor treatment industry in 2025 [Google translation] (Sina Corp) - "It is reported that in a mid-term trial of patients with surgically resected high-risk melanoma (stage III/IV), Moderna's personalized cancer vaccine mRNA-4157 (V940) combined with Merck's PD-1 inhibitor Keytruda can improve patient survival and show lasting efficacy. Morgan Stanley analyst Terence Flynn pointed out that Moderna is waiting for the key phase II interim data of this melanoma combination therapy in the fourth quarter of 25/26...BioNTech is expected to release updated Phase 3 data from its anti-CTLA-4 candidate BNT316 in NSCLC....In terms of anti-tigit therapy, Merck is waiting for phase 3 data on MK-7684A as a first-line combination therapy for non-small cell lung cancer..."

Clinical data • Melanoma • Non Small Cell Lung Cancer

A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) (clinicaltrials.gov) - P2 | N=191 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology

Merck Provides Update on KeyVibe and KEYFORM Clinical Development Programs Evaluating Investigational Vibostolimab and Favezelimab Fixed-Dose Combinations with Pembrolizumab (Businesswire) - "Merck is discontinuing the Phase 3 KeyVibe-003 and KeyVibe-007 trials, which are evaluating the fixed-dose combination of vibostolimab and pembrolizumab in certain patients with non-small cell lung cancer (NSCLC), based on the recommendation of an independent Data Monitoring Committee (DMC). In a pre-planned analysis, both trials met the pre-specified futility criteria for the primary endpoint of overall survival....The company has decided to discontinue the Phase 3 KeyVibe-006 trial and other vibostolimab studies. Separately, Merck has decided to end the favezelimab clinical development program, and will stop enrollment in the Phase 3 KEYFORM-008 trial evaluating the fixed-dose combination of favezelimab and pembrolizumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL)....The company has made this decision after a thorough evaluation of data from the favezelimab clinical program and will prioritize the development of other candidates..."

Discontinued • Trial termination • Hodgkin Lymphoma • Non Small Cell Lung Cancer

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) (clinicaltrials.gov) - P2 | N=320 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Nov 2025 ➔ Jun 2027 | Trial primary completion date: Oct 2025 ➔ Jun 2026

Metastases • Mismatch repair • Trial completion date • Trial primary completion date • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Frontline Vibostolimab/Pembrolizumab Plus Chemo Meets Futility Threshold in ES-SCLC (OncLive) - P3 | N=450 | KEYVIBE-008 (NCT05224141) | Sponsor: Merck Sharp & Dohme LLC | "Co-formulated vibostolimab and pembrolizumab plus chemotherapy failed to improve OS in the first line vs atezolizumab plus chemotherapy in ES-SCLC....As frontline therapy the investigational regimen led to a median OS of 11.5 months (95% CI, 9.8-12.6) vs 12.9 months (95% CI, 11.6-14.8) with the control regimen (HR, 1.26; 95% CI, 1.00-1.59; P =.9762). Median progression-free survival (PFS), a secondary end point, was 5.3 months (95% CI, 4.4-5.4) vs 4.5 months (95% CI, 4.4-5.3), respectively (HR, 1.01; 95% CI, 0.82-1.23)."

P3 data • Small Cell Lung Cancer