New event-free survival data from KEYNOTE-671 show potential of KEYTRUDA® (pembrolizumab)-based regimen as a perioperative treatment in earlier stages of lung cancer

Final overall survival data reinforce role of KEYTRUDA plus LENVIMA® (lenvatinib, in collaboration with Eisai) in advanced renal cell carcinoma (CLEAR/KEYNOTE-581)

First-time distant metastasis-free survival data (KEYNOTE-942/mRNA-4157-P201) and data from trial investigating MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate, showcase promise of Merck’s pipeline and importance of strategic collaborations

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that data for four approved medicines and two pipeline candidates in more than 25 types of cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2-6. Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s anti-PD-1 therapy; LENVIMA; LYNPARZA® (olaparib), in collaboration with AstraZeneca; and WELIREG™ (belzutifan). Additionally, Merck will present data from its broad pipeline, including V940/mRNA-4157, an investigational individualized neoantigen therapy (INT) being developed in collaboration with Moderna, in combination with KEYTRUDA, and MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech.

“At this year’s ASCO, data from our diverse portfolio and broad and expanding pipeline showcase how we continually challenge the status quo through our research to pursue meaningful advances in oncology,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “Building on our leadership with KEYTRUDA, which is now approved for 35 uses across 16 types of cancer, we will present compelling new investigational data from our expansive research program, including in earlier lines of therapy and stages of disease such as the KEYNOTE-671 study in non-small cell lung cancer, and data evaluating new combinations with KEYTRUDA.”

Key data from Merck’s portfolio to be presented at ASCO 2023:

• First-time data from the pivotal Phase 3 KEYNOTE-671 study, evaluating KEYTRUDA in the perioperative setting (neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant KEYTRUDA as a single-agent) for resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) (Abstract #LBA100; The Promise of Neoadjuvant Immunotherapy Across Solid Tumors Clinical Science Symposium);
• First presentation of results from the Phase 3 IND.227/KEYNOTE-483 trial in collaboration with the Canadian Cancer Trials Group (CCTG) evaluating KEYTRUDA plus chemotherapy as first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma (Abstract #LBA8505; Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Oral Abstract Session);
• Final overall survival (OS) results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating KEYTRUDA plus LENVIMA as a first-line treatment for advanced renal cell carcinoma (RCC) (Abstract #4502; Genitourinary Cancer – Kidney and Bladder Oral Abstract Session);
• Final distant metastasis-free survival (DMFS) data from the Phase 3 KEYNOTE-716 trial evaluating KEYTRUDA as adjuvant therapy for stage IIB and IIC melanoma (Abstract #LBA9505; Melanoma/Skin Cancers Oral Abstract Session);
• Final OS results from the Phase 3 KEYNOTE-826 trial evaluating KEYTRUDA in combination with chemotherapy with or without bevacizumab, as first-line treatment for persistent, recurrent or metastatic cervical cancer (Abstract #5500; Gynecologic Cancer Oral Abstract Session), which will be featured as part of the ASCO press program.

Key data from Merck’s pipeline to be presented at ASCO 2023:

• First presentation of DMFS data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating V940/mRNA-4157 in combination with KEYTRUDA as adjuvant treatment for high-risk melanoma (Abstract #LBA9503; Melanoma/Skin Cancers Oral Abstract Session);
• Additional data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 evaluating minimal residual disease as a predictive biomarker of recurrence-free survival (RFS) in patients with high-risk melanoma treated with V940/mRNA-4157 in combination with KEYTRUDA (Abstract #LBA9515; Melanoma/Skin Cancers Poster Discussion Session);
• Efficacy and safety data from a Phase 2 study evaluating MK-2870/SKB264, an anti-TROP2 antibody-drug conjugate in advanced NSCLC (Abstract #9114; Lung Cancer – Non-Small Cell Metastatic Poster Session).

Merck investor event

Merck will host an Oncology Investor Event to coincide with the ASCO Annual Meeting on Monday, June 5, 2023, 6 p.m. CT, at which senior management will provide an update on the company’s oncology strategy and program. The event will take place in Chicago, Ill., and will be accessible via webcast. Investors, analysts, members of the media and the general public are invited to listen to a webcast of the presentation at https://www.merck.com/events/merck-co-inc-investor-event-at-asco-2023/.

Details on abstracts listed above and additional key abstracts related to Merck portfolio and pipeline at ASCO 2023:

*In collaboration with Seagen **In collaboration with Eisai ***In collaboration with Seagen and Astellas ****In collaboration with AstraZeneca *****IND.227 was sponsored by CCTG, in collaboration with investigators in Italy (co-sponsored by National Cancer Institute of Naples - NCIN), and France (co-sponsored by The French Cooperative Thoracic Intergroup - IFCT); Merck provided KEYTRUDA and support for the trial.

About Merck’s early-stage cancer clinical program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA® (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (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 1,600 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 adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma 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.

KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

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, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy.

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 locally advanced or metastatic urothelial carcinoma (mUC):

• who are not eligible for any platinum-containing chemotherapy, or
• who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA, as a single agent, 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.

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, 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.

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, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (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 cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

Renal Cell Carcinoma

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

KEYTRUDA, in combination with LENVIMA, is indicated for the first-line treatment of adult patients with advanced RCC.

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

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 PD-1 or the 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. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. 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. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (