Publicado 14/09/2020 0:06:01 +02:00CET

Merck Advances Oncology Portfolio and Pipeline with New and Long-term Data in Multiple Cancers at ESMO 2020 (1)

· New analyses from Phase III JAVELIN Bladder 100 study of BAVENCIO(®*) assess efficacy across subgroups, patient-reported outcomes and exploratory biomarkers in advanced urothelial cancer

· Overall efficacy data, and analyses of brain metastases and HRQoL for tepotinib(**) from largest ongoing study in NSCLC harboring METex14 skipping

· Long-term follow-up data for novel bifunctional fusion protein targeting TGF- /PD-L1, bintrafusp alfa(***), in NSCLC and BTC demonstrate continued durability of response

Not intended for UK- US- or Canada-based media

DARMSTADT, Germany, Sept. 14, 2020 /PRNewswire/ -- Merck, a leading science and technology company, today announced more than 30 abstracts will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21. The abstracts span the Company's clinical program in oncology across several innovative modalities and mechanisms that have the potential to advance treatment across a range of tumor types including biliary tract, lung and urothelial (bladder) cancers.

https://mma.prnewswire.com/media/1136775/Merck_Logo.jpg [https://mma.prnewswire.com/media/1136775/Merck_Logo.jpg]

"Our oncology ambition is to discover innovative therapies with transformative results. The data being presented in urothelial cancer demonstrate this approach in action, where we are seeing promising results for a new first-line maintenance therapeutic option with BAVENCIO(®) in this form of cancer," said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck. "In addition, long-term follow-up data in advanced lung cancer from two of our in-house developed mechanisms--our oral MET inhibitor, tepotinib, and our first-in-class bifunctional fusion protein immunotherapy targeting TGF- /PD-L1, bintrafusp alfa--continue to show sustained impact in one of the leading causes of cancer mortality."

Key data highlights at ESMO

Avelumab (BAVENCIO(®))

Phase III JAVELIN Bladder 100 (Presentations #699O; 704MO; 745P). Primary results from the JAVELIN Bladder 100 study demonstrated an overall survival (OS) benefit for BAVENCIO vs. best supportive care in the first-line maintenance treatment of advanced urothelial carcinoma, making BAVENCIO the first and only immunotherapy to significantly prolong OS in this setting. Three new abstracts from the JAVELIN Bladder 100 study will be presented at ESMO:

-- An oral presentation during the Proffered Paper 1 - GU, non-prostate session scheduled on September 19, 2020 at 5:28pm-5:40pm CEST/11:28am-11:40am EDT, will highlight associations between clinical outcomes and exploratory biomarkers (Presentation #699O) -- Two other abstracts provide more information on prespecified subgroup analyses, as well as patient-reported outcomes.

Phase III JAVELIN Head and Neck 100 (Presentation #910O). Primary results from this Phase III study will be presented. The study is a demonstration of our commitment to develop options for patients with squamous cell carcinoma of the head and neck, and the results increase understanding in the field of the role of immunotherapy.

Tepotinib
Phase II VISION (Presentations: #1283P; 1286P; 1347P). Three posters from the largest study in patients with non-small cell lung cancer (NSCLC) harboring METex14 skipping treated with tepotinib--an oral, once-daily, highly-selective MET inhibitor. Data presented will highlight:

-- Durable clinical activity that has been consistent across clinically relevant subgroups both in treatment-naïve and in previously treated patients as well as in patients with brain metastases as assessed by liquid biopsy or tissue biopsy (Poster #1283P) -- Health-related quality of life (HRQOL) has shown to be maintained, with clinically meaningful delays in the time to deterioration of cough, dyspnea, and chest pain (Poster #1286P) -- A safety profile consisting of mostly mild-to-moderate adverse events with few treatment discontinuations.

INSIGHT 2 (NSCLC): The INSIGHT 2 study assessing the combination of osimertinib and tepotinib in patients with EGFR-mutant NSCLC that has developed resistance to first-line osimertinib treatment due to MET amplification is ongoing and actively recruiting patients (Poster #1415TiP).

Bintrafusp alfa (M7824)

Data from the INTR@PID clinical trial program for first-in-class bintrafusp alfa, an investigational bifunctional fusion protein, targeting both TGF- and PD-L1 pathways, shows promising and durable responses across multiple tumor types including NSCLC and biliary tract cancer (BTC) with a manageable safety profile in Phase I expansion cohorts.

Two long-term follow-up studies assessing efficacy and safety from the INTR@PID clinical trial program will be presented as posters at ESMO 2020:

-- INTR@PID Solid Tumor 001 three-year long-term follow-up for 2L treatment of NSCLC (Poster #1272P) -- INTR@PID Solid Tumor 008 28-month long-term follow-up in patients with pretreated biliary tract cancer (Poster #73P)

In addition, preliminary analysis will be presented in a mini-oral presentation (#616MO) from a trial conducted by the National Cancer Institute (NCI), the Quick Efficacy Seeking Trial (QuEST), investigating a triple combination therapy (BN-brachyury [BVax] + bintrafusp alfa + N-803) in castration-resistant prostate cancer. Available on demand from September 18 at ESMO.org.

Cetuximab (ERBITUX(®)) (Presentations: #397O; 402MO; 511P; 960P; 922P)

For the Company's first biology-driven leader ERBITUX, a number of investigator-sponsored studies (ISS), including in combination with BAVENCIO (avelumab), continue to demonstrate its steady role across the continuum of care in metastatic colorectal cancer, and backbone of treatment of squamous cell carcinoma of the head and neck. Data demonstrating the role of ERBITUX as a promising combination partner include an oral presentation investigating avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients as re-challenge strategy: the Phase II CAVE (cetuximab-avelumab) mCRC study. This will be presented during the Proffered Paper GI - colorectal session scheduled on September 19, 2:49pm-3:01pm CEST/8:49am-9:01am EDT (Presentation #397O)

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC and not yet approved in any markets outside of the US.

(**)Tepotinib is the International Nonproprietary Name (INN) for the MET kinase inhibitor MSC2156119J. Tepotinib is currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.

(***)Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About BAVENCIO(® )(avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.(10-12) In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications

The European Commission has authorized the use of BAVENCIO in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). In September 2017, the European Commission granted conditional marketing authorization for BAVENCIO as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

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