Merck Highlights Scientific Data at 2021 ASCO Annual Meeting Across More Than 20 Cancer Types From Broad Oncology Research Program

First-Time Data for KEYTRUDA^® (pembrolizumab) in Early-Stage Kidney Cancer and for LYNPARZA^® (olaparib) in Early-Stage Breast Cancer To Be Featured in ASCO Plenary Session

New Data To Be Presented for KEYTRUDA in Advanced Gastric Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that data spanning more than 20 cancer types from its oncology research program will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8. These data include new or updated findings from Merck’s broad oncology portfolio and diverse pipeline including KEYTRUDA, Merck’s anti-PD-1 therapy; LYNPARZA (in collaboration with AstraZeneca); LENVIMA^® (lenvatinib, in collaboration with Eisai); and belzutifan, an investigational hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor.

“Our expansive oncology clinical development program is designed to help us understand the full potential of our established and pipeline medicines and identify new avenues of treatment, including in earlier lines of therapy and in combination with other oncology therapies,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “At this year’s ASCO, we will present new clinical and real-world data highlighting how our oncology medicines are making a meaningful impact on the lives of people with cancer and driving forward future innovations in cancer care.”

Key data from Merck’s portfolio to be presented at ASCO include:

KEYTRUDA

• First presentation of data from the Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA as an adjuvant treatment for patients with renal cell carcinoma (RCC) following nephrectomy. These late-breaking results will be presented in the ASCO Plenary Session and highlighted in the ASCO Press Program (Abstract #LBA5).
• First presentation of data from the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for patients with locally advanced unresectable or metastatic high-risk human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma (Abstract #4013).
• Updated results from the Phase 3 KEYNOTE-054 trial evaluating KEYTRUDA as an adjuvant treatment for patients with high-risk stage III melanoma following complete resection (Abstract #9500).
• Updated results from the Phase 2 KEYNOTE-799 trial evaluating KEYTRUDA plus concurrent chemoradiation therapy for patients with unresectable, locally advanced, stage III non-small cell lung cancer (Abstract #8512).
• Five-year response and survival data from the Phase 2 KEYNOTE-052 trial evaluating KEYTRUDA as a first-line treatment for patients with advanced urothelial cancer who are cisplatin-ineligible (Abstract #4508).
• Five-year follow-up data from the Phase 3 KEYNOTE-045 trial evaluating KEYTRUDA as a second-line treatment for patients with advanced urothelial cancer (Abstract #4532).
• Final results from the Phase 3 KEYNOTE-426 trial evaluating KEYTRUDA in combination with Inlyta^® (axitinib) as a first-line treatment for patients with advanced or metastatic RCC (Abstract #4500).

LYNPARZA

• First-time data from the Phase 3 OlympiA trial evaluating LYNPARZA as an adjuvant treatment for patients with germline BRCA-mutated high-risk HER2-negative early-stage breast cancer following definitive local treatment and neoadjuvant or adjuvant chemotherapy. These results will be presented in the ASCO Plenary Session and highlighted in the ASCO Press Program (Abstract #LBA1).

KEYTRUDA plus LENVIMA

• Updated findings from the Phase 2 LEAP-004 study evaluating KEYTRUDA plus LENVIMA as a second-line treatment for patients with melanoma who progressed on anti-PD-1/PD-L1 therapy (Abstract #9504).
• Health-related quality-of-life data from the Phase 3 CLEAR trial (KEYNOTE-581/Study 307) evaluating KEYTRUDA plus LENVIMA as a first-line treatment for patients with advanced RCC (Abstract #4502).
• Health-related quality-of-life data from the Phase 3 KEYNOTE-775/Study 309 evaluating KEYTRUDA plus LENVIMA as a second-line treatment for certain patients with advanced endometrial cancer following at least one prior platinum-based chemotherapy regimen in any setting (Abstract #5570).

Pipeline

• Updated findings from a Phase 2 study evaluating belzutifan for treatment of von Hippel-Lindau (VHL) disease-associated clear cell RCC (Abstract #4555).

Merck Investor Event

Merck will hold a virtual investor event in conjunction with the 2021 ASCO Annual Meeting on Monday, June 7 from 6-7 p.m. ET. Details will be provided at a date closer to the event at https://www.merck.com/investor-relations.

Details on Abstracts Listed Above and Additional Key Abstracts for Merck

KEYTRUDA

Bladder Cancer

• Abstract #4532, Poster Session: Pembrolizumab (Pembro) Versus Investigator’s Choice of Paclitaxel, Docetaxel, or Vinflunine in Recurrent, Advanced Urothelial Cancer (UC): 5-Year Follow-Up From the Phase 3 KEYNOTE-045 Trial. J. Bellmunt.
• Abstract #4508, Oral Abstract Session: First-Line Pembrolizumab (Pembro) in Cisplatin-Ineligible Patients With Advanced Urothelial Cancer (UC): Response and Survival Results up to Five Years From the KEYNOTE-052 Phase 2 Study. P. O’Donnell.

Gastric Cancer

• Abstract #4013, Poster Discussion Session: Pembrolizumab Plus Trastuzumab and Chemotherapy for HER2+ Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Cancer: Initial Findings of the Global Phase 3 KEYNOTE-811 Study. Y. Janjigian.

Head and Neck Cancer

• Abstract #9546, Poster Session: KEYNOTE-629: Health-Related Quality of Life (HRQoL) With Pembrolizumab (Pembro) in Patients (Pts) With Locally Advanced (LA) or Recurrent or Metastatic (R/M) Cutaneous Squamous Cell Carcinoma (cSCC). Å. Bratland.

Lung Cancer

• Abstract #8512, Poster Discussion Session: KEYNOTE-799: Phase 2 Trial of Pembrolizumab Plus Platinum Chemotherapy and Radiotherapy for Unresectable, Locally Advanced, Stage III NSCLC. S. Jabbour.

Melanoma

• Abstract #9541, Poster Session: KEYNOTE-555 Cohort B: Efficacy, Safety and PK of Pembrolizumab (Pembro) 400 mg Every 6 Weeks (Q6W) as First-Line Therapy for Advanced Melanoma. C. Jacobs.
• Abstract #9500, Oral Abstract Session: Crossover and Rechallenge With Pembrolizumab in Recurrent Patients From the EORTC 1325-MG/KEYNOTE-054 Phase 3 Trial, Pembrolizumab Versus Placebo After Complete Resection of High-Risk Stage III Melanoma. A. Eggermont.

Prostate Cancer

• Abstract #5042, Poster Session: Pembrolizumab Plus Enzalutamide for Enzalutamide-Resistant Metastatic Castration-Resistant Prostate Cancer (mCRPC): Updated Analyses After One Additional Year of Follow-up From Cohorts 4 and 5 of the KEYNOTE-199 Study. J. Graff.

Renal Cell Carcinoma

• Abstract #LBA5, Plenary Session: Pembrolizumab (Pembro) Versus Placebo as Post-Nephrectomy Adjuvant Therapy for Patients With Renal Cell Carcinoma: Randomized, Double-Blind, Phase 3 KEYNOTE-564 Study. T. Choueiri.
• Abstract #4500, Oral Abstract Session: Pembrolizumab (Pembro) Plus Axitinib (Axi) Versus Sunitinib as First-Line Therapy for Advanced Clear Cell Renal Cell Carcinoma (ccRCC): Results From 42-Month Follow-up of KEYNOTE-426. B. Rini.

LYNPARZA (in Collaboration With AstraZeneca)

Breast Cancer

• Abstract #LBA1, Plenary Session: OlympiA: A Phase 3, Multicenter, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib After (Neo)Adjuvant Chemotherapy in Patients With Germline BRCA1/2 Mutations and High-Risk HER2-Negative Early Breast Cancer. A. Tutt.

Ovarian Cancer

• Abstract #5545, Poster Session: Olaparib Maintenance Monotherapy for Non-Germline BRCA1/2-Mutated (Non-gBRCAm) Platinum-Sensitive Relapsed Ovarian Cancer (PSR OC) Patients (Pts): Phase IIIb OPINION Primary Analysis. A. Poveda.

KEYTRUDA Plus LENVIMA (in Collaboration With Eisai)

Endometrial Cancer

• Abstract #5570, Poster Session: Health-Related Quality of Life (HRQoL) in Advanced Endometrial Cancer (aEC) Patients (Pts) Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician’s Choice (TPC). D. Lorusso.

Melanoma

• Abstract #9504, Oral Abstract Session: Lenvatinib (Len) Plus Pembrolizumab (Pembro) for Patients (Pts) With Advanced Melanoma and Confirmed Progression on a PD-1 or PD-L1 Inhibitor: Updated Findings of LEAP-004. A. Arance.

Renal Cell Carcinoma

• Abstract #4502, Oral Abstract Session: Health-Related Quality-of-Life (HRQoL) Analysis From the Phase 3 CLEAR Trial of Lenvatinib (Len) Plus Pembrolizumab (Pembro) or Everolimus (Eve) Versus Sunitinib (Sun) for Patients (Pts) With Advanced Renal Cell Carcinoma (aRCC). R. Motzer.
• Abstract #4560, Poster Session: Analysis of the CLEAR Study in Patients (Pts) With Advanced Renal Cell Carcinoma (RCC): Depth of Response and Efficacy for Selected Subgroups in the Lenvatinib (Len) + Pembrolizumab (Pembro) and Sunitinib (Sun) Treatment Arms. V. Grünwald.
• Abstract #4562, Poster Session: Post-Hoc Analysis of the CLEAR Study in Advanced Renal Cell Carcinoma (RCC): Effect of Subsequent Therapy on Survival Outcomes in the Lenvatinib (Len) + Everolimus (Eve) Versus Sunitinib (Sun) Treatment Arms. T. Huston.

Pipeline

Colorectal Cancer

• Abstract #3584, Poster Session: A Phase 1 First-in-Human Study of the Anti-LAG-3 Antibody MK-4280 (Favezelimab) Plus Pembrolizumab in Previously Treated, Advanced Microsatellite Stable Colorectal Cancer. E. Garralda.

Renal Cell Carcinoma

• Abstract #4555, Poster Session: Phase 2 Study of Belzutifan (MK-6482), an Oral Hypoxia-Inducible Factor 2α (HIF-2α) Inhibitor, for Von Hippel-Lindau (VHL) Disease-Associated Clear Cell Renal Cell Carcinoma (ccRCC). R. Srinivasan.

About KEYTRUDA^® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA^® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

• solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
• colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, and fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

• in combination with platinum- and fluoropyrimidine-based chemotherapy, or
• as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions.

Contacts

Media

Patrick Ryan, (973) 275-7075

Kristen Drake, (908) 740-1679

Investor:

Peter Dannenbaum, (908) 740-1037

Courtney Ronaldo, (908) 740-6132

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