favezelimab/pembrolizumab (MK-4280A) / Merck (MSD) - LARVOL DELTA

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

KEYFORM-008: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2031 ➔ Jan 2026 | Trial primary completion date: May 2027 ➔ Jan 2026

Trial completion date • Trial primary completion date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

KEYMAKER-U06 substudy 06A: A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A) (clinicaltrials.gov) - P1/2 | N=120 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2026 ➔ Nov 2025 | Trial primary completion date: Mar 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

KEYMAKER-U03B: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) (clinicaltrials.gov) - P1/2 | N=370 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2025 ➔ May 2026 | Trial primary completion date: Sep 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

KEYFORM-008: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Phase classification: P3 ➔ P2 | N=360 ➔ 200

Enrollment change • Phase classification • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) (clinicaltrials.gov) - P3 | N=505 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor

KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study (clinicaltrials.gov) - P3 | N=94 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor

KeyImPaCT: A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov) - P2 | N=318 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2025 ➔ Nov 2025 | Trial primary completion date: Jun 2025 ➔ Nov 2025

Biomarker • Trial completion date • Trial primary completion date • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

KEYFORM-007 Results: Co-Formulated Favezelimab and Pembrolizumab in Metastatic Colorectal Cancer (DocWire) - P3 | N=505 | KEYFORM-007 (NCT05064059) | Sponsor: Merck Sharp & Dohme LLC | "After a median follow-up of 28 months, the study revealed that favezelimab/pembrolizumab did not demonstrate a survival benefit over SOC. Median OS was 7.3 months with favezelimab/pembrolizumab compared with 8.5 months with SOC (hazard ratio, 0.98, P=.4183). Similarly, median PFS was 2.1 months versus 2.6 months, respectively, with no statistical significance. Despite the lack of OS and PFS benefits, the ORR was notably higher with favezelimab/pembrolizumab, with 6.8% of patients achieving a response compared with 0.9% in the SOC arm. Responses in the favezelimab/pembrolizumab arm were durable, with the median DOR not reached among responders, compared with 6.5+ months in the SOC arm."

P3 data • Colorectal Cancer

Co-formulated favezelimab plus pembrolizumab versus standard-of-care in previously treated, PD-L1-positive metastatic colorectal cancer: The phase 3, randomized KEYFORM-007 study. (ASCO-GI 2025) - P3 | " Eligible pts with PD-L1 CPS ≥1, MSS/pMMR unresectable mCRC (Stage IV per AJCC 8th edition), who had progressed on or after, or could not tolerate standard treatment were randomized 1:1 to co-formulated fave 800 mg/pembro 200 mg IV Q3W (Arm A) or SOC (regorafenib 160 mg PO Q4W [QD on days 1-21] or TAS-102 35 mg/m2 PO Q4W [BID on days 1-5 and 8-12]) (Arm B). At final analysis, co-formulated fave/pembro did not improve OS vs SOC in pts with PD-L1-positive MSS/pMMR mCRC. The safety profile was manageable with no new safety signals observed."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P3 data • Colorectal Cancer • Gastrointestinal 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

KeyForm-010: Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Endometrial Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

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

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

KEYFORM-008: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) (clinicaltrials.gov) - P3 | N=360 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

COFORMULATED FAVEZELIMAB AND PEMBROLIZUMAB (PEMBRO) VERSUS CHEMOTHERAPY (CHEMO) IN PATIENTS (PTS) WITH RELAPSED OR REFRACTORY (R/R) CLASSICAL HODGKIN LYMPHOMA (CHL) REFRACTORY TO ANTI–PD-1 THERAPY: THE PHASE 3 KEYFORM-008 STUDY (ISHL 2024) - P3 | "Pts must also have been ineligible for brentuximab vedotin (BV), relapsed on or whose disease failed to respond to BV, or discontinued BV due to toxicity. Approximately 360 pts will be enrolled and randomly assigned 1:1 to receive coformulated favezelimab 800 mg/pembrolizumab 200 mg IV Q3W or physician's choice of chemo (gemcitabine, 800–1200 mg/m2 IV or bendamustine, 90–120 mg/m2 IV)... Results of KEYFORM-008 will provide clarity on the efficacy and safety of coformulated favezelimab/pembro versus chemo in pts with anti–PD-1–refractory R/R cHL"

Clinical • P3 data • Bone Marrow Transplantation • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

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

KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007) (clinicaltrials.gov) - P3 | N=505 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Nov 2025 ➔ Feb 2025

Metastases • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study (clinicaltrials.gov) - P3 | N=94 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Nov 2025 ➔ Feb 2025

Metastases • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting | N=80 ➔ 110 | Trial completion date: Nov 2026 ➔ Nov 2029 | Trial primary completion date: Nov 2026 ➔ May 2026

Combination therapy • Enrollment change • Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Merck Provides Update on Phase 3 KEYFORM-007 Trial Evaluating Investigational Fixed-Dose Combination of Favezelimab and Pembrolizumab for Patients With Previously Treated PD-L1 Positive Microsatellite Stable Metastatic Colorectal Cancer (Businesswire) - P3 | N=505 | KEYFORM-007 (NCT05064059) | Sponsor: Merck Sharp & Dohme LLC | "At the final pre-specified analysis, the favezelimab and pembrolizumab fixed-dose combination did not demonstrate an improvement in OS compared to standard of care (regorafenib or TAS-102 [trifluridine and tipiracil hydrochloride]). The safety profile of the fixed-dose combination was consistent with that observed for favezelimab and pembrolizumab in previously reported studies, with no new safety signals observed. A full evaluation of the data is ongoing and Merck will work with investigators to share the results with the scientific community."

P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Definitely great randomized design to allow early signal finding in the neoadjuvant setting. Good to see anti-LAG3 ab Favezilumab + pembro showing results very consistent w nivo+ relatlimab neoadjuvant data from Prof. Amaria. Biomarker analysis being presented @Liz_htx03 #ESMO2024 poster session soon

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 | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Mismatch repair • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

KEYFORM-007: A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study (clinicaltrials.gov) - P3 | N=94 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jul 2025 ➔ Nov 2025

Metastases • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

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=80 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hematological Malignancies • Oncology • Pediatrics • Solid Tumor