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

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

Favezelimab in Combination with Pembrolizumab in Patients with Heavily Pretreated Anti–PD-1–Refractory Classical Hodgkin Lymphoma: Updated Analysis of an Open-Label Phase 1/2 Study (ASH 2023) - P1/2, P2 | "After additional follow-up, the combination of favezelimab + pembrolizumab continued to demonstrate manageable safety and antitumor activity in patients with heavily pretreated anti–PD-1–refractory cHL. Analyses are underway to identify biomarkers predictive of response to the combination of favezelimab and pembrolizumab. The phase 3 KEYFORM-008 study (NCT05508867) is being conducted to evaluate a coformulation of favezelimab and pembrolizumab in patients with anti–PD-1–refractory cHL."

Clinical • Combination therapy • IO biomarker • P1/2 data • Acute Graft versus Host Disease • Bone Marrow Transplantation • Classical Hodgkin Lymphoma • CNS Disorders • Diabetes • Endocrine Disorders • Fatigue • Graft versus Host Disease • Hematological Malignancies • Hepatology • Hodgkin Lymphoma • Immunology • Lymphoma • Melanoma • Metabolic Disorders • Oncology • Solid Tumor • Transplantation • Type 1 Diabetes Mellitus

Favezelimab in Combination with Pembrolizumab in Patients with Anti–PD-1–Naive Relapsed or Refractory Classical Hodgkin Lymphoma: Updated Analysis of an Open-Label Phase 1/2 Study (ASH 2023) - P1/2 | "With additional follow-up, the combination of favezelimab and pembrolizumab continued to demonstrate sustained antitumor activity and manageable safety in patients with anti–PD-1–naive R/R cHL. Analyses are underway to identify biomarkers predictive of response to the combination of favezelimab and pembrolizumab. Further studies to investigate this combination are warranted."

Clinical • Combination therapy • IO biomarker • P1/2 data • Classical Hodgkin Lymphoma • Endocrine Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Hodgkin Lymphoma • Immunology • Lymphoma • Melanoma • Oncology • Pneumonia • Solid Tumor • LAG3

Favezelimab (anti–LAG-3) Plus Pembrolizumab in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Cohort 3 of a Multicohort Open-Label Phase 1/2 Study (ASH 2023) - P1/2 | "Favezelimab 800 mg plus pembrolizumab 200 mg had limited antitumor activity in patients with DLBCL in cohort 3. Analyses are underway to identify biomarkers predictive of response to the combination of favezelimab and pembrolizumab. The safety profile was manageable and consistent with that observed in other cohorts in the study."

Clinical • IO biomarker • P1/2 data • B Cell Lymphoma • Classical Hodgkin Lymphoma • Constipation • Cough • Diffuse Large B Cell Lymphoma • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Respiratory Diseases • Richter's Syndrome

Open-Label, Randomized, Phase 3 Study of Coformulated Favezelimab and Pembrolizumab Versus Chemotherapy in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma Refractory to Anti–PD-1 Therapy: Keyform-008 (ASH 2023) - P2 | "In addition, patients should also have been ineligible for brentuximab vedotin (BV), relapsed or failed to respond to BV or discontinued BV due to toxicity...Approximately 360 patients will be enrolled and randomly assigned 1:1 to receive coformulated favezelimab 800 mg and pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) or physician's choice of chemotherapy (gemcitabine 800-1200 mg/m2 IV on days 1 and 8 of a 21-day cycle or bendamustine 90-120 mg/m2 IV on days 1 and 2 of either a 21- or 28-day cycle)...Reused with permission. This abstract was accepted and previously presented at the 2023 ASCO Annual Meeting."

Clinical • P3 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • HLA-DRB1 • LAG3

Coformulation of favezelimab and pembrolizumab as neoadjuvant therapy for resectable cutaneous squamous cell carcinoma (cSCC): results from cohort A of the phase 2 KeyForm-010 study (SITC 2025) - P2 | "All participants provided written informed consent before enrollment. Abstract 1305 Table 1View inline•Open as popupEfficacy resultsAbstract 1305 Table 2View inline•Open as popupSummary of AEs during neoadjuvant phasea"

Clinical • Late-breaking abstract • P2 data • Head and Neck Cancer • Melanoma • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • PD-L1

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

KEYMAKER-U02 Substudy 02C: Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02) (clinicaltrials.gov) - P1/2 | N=146 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed | N=90 ➔ 146

Enrollment change • Trial completion • Melanoma • Oncology • 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=203 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Jan 2026 ➔ Sep 2025

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

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

KEYMAKER-U02 Substudy 02C: Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02) (clinicaltrials.gov) - P1/2 | N=90 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2030 ➔ Oct 2025 | Trial primary completion date: Apr 2030 ➔ Oct 2025

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

KEYMAKER-U02 Substudy 02B: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) (clinicaltrials.gov) - P1/2 | N=315 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Apr 2030 ➔ Apr 2026 | Trial primary completion date: Apr 2030 ➔ Apr 2026

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

KEYMAKER-U02 Substudy 02B: Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02) (clinicaltrials.gov) - P1/2 | N=315 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Melanoma • Oncology • Solid Tumor

Estimating efficacy of favezelimab plus pembrolizumab relative to pembrolizumab in anti-PD-1-refractory Hodgkin lymphoma. (PubMed, Blood Adv) - P1/2, P2 | "Favezelimab plus pembrolizumab had a higher response rate and greater reduction in tumor burden vs pembrolizumab alone in anti-PD-1-refractory classical Hodgkin lymphoma, suggesting favezelimab contributed substantially to efficacy in MK-4280-003. NCT03598608, NCT02453594."

Journal • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

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=245 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Jun 2025 | Trial primary completion date: Nov 2025 ➔ Jun 2025

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

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