Merck Highlights New Data from Leading Lung Cancer Clinical Development Program at the IASLC 2019 World Conference on Lung Cancer

Pooled Overall Survival (OS) Data from Three Trials with KEYTRUDA^® (pembrolizumab) Plus Chemotherapy in Subgroup of Patients with Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Do Not Express PD-L1

New KEYTRUDA Monotherapy Data in NSCLC Include Three-Year OS Data from Phase 3 KEYNOTE-024 and First-Time Data in Chinese Patients from Phase 3 KEYNOTE-042

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from the company’s leading clinical development program in lung cancer will be presented at the IASLC 2019 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain from Sept. 7-10, 2019. More than 30 abstracts evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with other cancer therapies and as monotherapy, will be presented. Key data to be presented in non-small cell lung cancer (NSCLC) include new pooled findings from three trials – KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 (cohort G) – evaluating KEYTRUDA in combination with chemotherapy among a subgroup of patients whose tumors do not express PD-L1. Three-year overall survival (OS) data with KEYTRUDA monotherapy from KEYNOTE-024 will also be presented and was selected for inclusion in the official WCLC press program.

“Our robust lung cancer clinical development program continues to demonstrate that KEYTRUDA provides a foundation for the treatment of non-small cell lung cancer,” Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “At this year’s World Conference on Lung Cancer, we look forward to presenting new and updated data that further reinforce the overall survival benefit of KEYTRUDA, in combination with chemotherapy or as monotherapy, in appropriate patients with advanced non-small cell lung cancer.”

Key oral data presentations include:

• First presentation of pooled data from a subgroup of patients whose tumors do not express PD-L1 from the randomized KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 (cohort G) studies evaluating KEYTRUDA in combination with chemotherapy as first-line treatment in patients with advanced nonsquamous and squamous NSCLC (Abstract #MA25.01) will be presented in a mini oral session on Tuesday, Sept. 10, 2:30-2:37 p.m. CEST.
• Three-year OS data from the pivotal Phase 3 KEYNOTE-024 study evaluating KEYTRUDA monotherapy as first-line treatment in patients with advanced NSCLC whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%) (Abstract #OA14.01) will be presented in an oral session on Tuesday, Sept. 10, 11:30-11:40 a.m. CEST and highlighted in the official WCLC press program.
• First presentation of data from a cohort of Chinese patients enrolled in the pivotal Phase 3 KEYNOTE-042 study evaluating KEYTRUDA monotherapy as first-line treatment in patients with advanced NSCLC whose tumors express PD-L1 (TPS ≥1%) (Abstract #MA11.02) will be presented in a mini oral session on Monday, Sept. 9, 2:05-2:10 p.m. CEST.
• First presentation of tissue tumor mutational burden (tTMB) data from the pivotal Phase 3 KEYNOTE-189 study evaluating KEYTRUDA in combination with pemetrexed (ALIMTA^®) and platinum chemotherapy as first-line treatment in patients with metastatic nonsquamous NSCLC (Abstract #OA04.06) will be presented in an oral session on Sunday, Sept. 8, 4:10-4:20 p.m. CEST and highlighted in the official WCLC press program.
• First presentation of tTMB data from the Phase 1/2 KEYNOTE-021 study evaluating KEYTRUDA in combination with platinum chemotherapy as first-line treatment in patients with metastatic nonsquamous NSCLC (Abstract #OA04.05) will be presented in an oral session on Sunday, Sept. 8, 4:00-4:10 p.m. CEST and highlighted in the official WCLC press program.

Other select abstracts to be presented from Merck’s clinical development program include:

• Abstract #MA03.06, Mini Oral Session: Efficacy Results of Selective AXL Inhibitor Bemcentinib with Pembrolizumab Following Chemotherapy in Patients with NSCLC. E. Felip. Sunday, Sept. 8, 11:05-11:10 a.m. CEST. Location: Colorado Springs (1994).
• Abstract #MA14.07, Mini Oral Session: Phase I Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naïve Non-Small Cell Lung Cancer (JVDF). R. Herbst. Monday, Sept. 9, 4:25-4:30 p.m. CEST. Location: Hilton Head (1978).

• Abstract #MA19.03, Mini Oral Session: Differences in Symptom Burden Between Responsive and Progressive Disease in Advanced Non-Small Cell Lung Cancer (aNSCLC). G. Simon. Tuesday, Sept. 10, 11:40-11:45 a.m. CEST. Location: Interlaken (1988).

• Abstract #P1.01-72, Poster Viewing: A Phase II Study of Selective AXL Inhibitor Bemcentinib and Pembrolizumab in Patients with NSCLC Refractory to Anti-PD(L)1. M. Krebs. Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.
• Abstract #P1.01-73, Poster Viewing: An Explorative Analysis of Pemetrexed +/- Pembrolizumab Maintenance from KEYNOTE-189 Versus PARAMOUNT, PRONOUNCE, and JVBL. E. Garon. Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.
• Abstract #P1.01-107, Poster Viewing: KEYNOTE-495/KeyImPaCT: Phase 2 Biomarker-Directed Study of Pembrolizumab-Based Therapy for Non–Small Cell Lung Cancer. M. Gutierrez. Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.
• Abstract #P1.01-112, Poster Viewing: Phase 3, Randomized, Double-Blind Trial of First-Line Pembrolizumab With or Without Lenvatinib in Metastatic NSCLC: LEAP-007. T. Mekhail. Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.
• Abstract #P1.16-15, Poster Viewing: Rates of Systemic Anticancer Therapy (SACT) for Advanced Non-Small Cell Lung Cancer (aNSCLC) in the US, 2011–2018. V. Velcheti. Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.

• Abstract #P1.16-31, Poster Viewing: Body Mass Index Relating to Patient-Reported Symptoms in First-Line Treatment of Metastatic Non-Small Cell Lung Cancer. G. Simon. Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.

• Abstract #P1.16-42, Poster Viewing: Real-World Trends in Systemic Anticancer Therapy (SACT) for Squamous Advanced NSCLC (aNSCLC) in the US, 2011–2018. V. Velcheti. Sunday, Sept. 8, 9:45 a.m. CEST. Location: Exhibit Hall.
• Abstract #P2.16-17, Poster Viewing: Real-World Trends in Systemic Therapy for Nonsquamous EGFR/ALK-Negative Advanced NSCLC (aNSCLC) in the US, 2011–2018. V. Velcheti. Monday, Sept. 9, 10:15 a.m. CEST. Location: Exhibit Hall.
• Abstract #P2.16-41, Poster Viewing: Pembrolizumab for Previously Treated, PD-L1–Expressing Advanced NSCLC: Real-World Time on Treatment and Overall Survival. V. Velcheti. Monday, Sept. 9, 10:15 a.m. CEST. Location: Exhibit Hall.

• Abstract #P2.01-54, Poster Viewing: Real-World PD-L1 Testing Patterns for Patients with Advanced Non-Small Cell Lung Cancer in Greece. K. Syrigos. Monday, Sept. 9, 10:15 a.m. CEST. Location: Exhibit Hall.
• Abstract #P2.01-12, Poster Viewing: A Phase I/II Trial of IO102 and Pembrolizumab with/without Chemotherapy as First-line Treatment of Metastatic NSCLC. M. Provencio. Monday, Sept. 9, 10:15 a.m. CEST. Location: Exhibit Hall.

Additional meeting information and select full abstracts are available on the WCLC website.

The KEYNOTE-021 (cohort G) and KEYNOTE-189 studies were conducted in collaboration with Eli Lilly and Company, the makers of pemetrexed (ALIMTA^®).

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10 to 15% of all lung cancers. The five-year survival rates for patients diagnosed in the United States with any stage of NSCLC or SCLC are estimated to be 23% and 6%, respectively.

About KEYTRUDA^® (pembrolizumab) Injection, 100mg

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 1,000 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.

KEYTRUDA^® (pembrolizumab) Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. The recommended dose of KEYTRUDA in patients with unresectable or metastatic melanoma is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. The recommended dose of KEYTRUDA for the adjuvant treatment of adult patients with melanoma is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease recurrence, unacceptable toxicity, or for up to 12 months in patients without disease recurrence.

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.

In NSCLC, the recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, administer KEYTRUDA prior to chemotherapy when given on the same day. Refer to the Prescribing Information for the chemotherapy agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of 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 confirmatory trials. In SCLC, the recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Head and Neck 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.

In HNSCC, the recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, administer KEYTRUDA prior to chemotherapy when given on the same day. Refer to the Prescribing Information for the chemotherapy agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of 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. In adults with cHL, KEYTRUDA 200 mg is administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression. In pediatric patients with cHL, KEYTRUDA is administered as an intravenous infusion over 30 minutes at a dose of 2 mg/kg (up to a maximum of 200 mg) every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

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. 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 confirmatory trials. KEYTRUDA is not recommended for the treatment of patients with PMBCL who require urgent cytoreductive therapy.

In adults with PMBCL, KEYTRUDA 200 mg is administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

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 the 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.

In locally advanced or metastatic urothelial carcinoma, KEYTRUDA 200 mg is administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Microsatellite Instability-High (MSI-H) 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.

In adult patients with MSI-H cancer, KEYTRUDA 200 mg is administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Gastric Cancer

KEYTRUDA 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. The recommended dose of KEYTRUDA is 200 mg as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

In patients with esophageal cancer, the recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

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. The recommended dose of KEYTRUDA is 200 mg as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity or up to 24 months in patients without disease progression.

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. The recommended dose of KEYTRUDA is 200 mg as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. 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 recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). In RCC, KEYTRUDA 200 mg is administered as an intravenous infusion over 30 minutes every 3 weeks in combination with 5 mg axitinib orally twice daily until disease progression, unacceptable toxicity, or for KEYTRUDA, up to 24 months in patients without disease progression. When axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer. See also the Prescribing Information for recommended axitinib dosing information.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grade 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis.

Contacts

Media Contacts:

Pamela Eisele

(267) 305-3558

Justine Moore

(347) 281-3754

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807

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