Shaping Cancer Care Today and Tomorrow: Merck to Present New Data from Rapidly Evolving Pipeline at ASCO 2017 (1)

Publicado 17/05/2017 23:06:15CET

DARMSTADT, Germany, May 17, 2017 /PRNewswire/ --

Not intended for UK- or U.S.-based media  

ASCO Abstract #

M7824 (anti-PD-L1/TGF-ss trap): 3006; Avelumab: 9086, 9530, 9557, 4528, 3059, 5037, e21070, e21065, e20581; Tepotinib: 4087, 8547, e15676, 20541; M3814 (DNA-PK): 2556, e14048; M7583 (BTKi): e14101

- ASCO data highlights Merck's strong and rapidly accelerating pipeline in oncology, spanning immuno-oncology to DNA damage response  - New avelumab data in metastatic Merkel cell carcinoma and previously treated metastatic urothelial carcinoma, following recent U.S. FDA accelerated approvals   - Oral presentation on new immuno-oncology approach anti-PD-L1/TGF-ss trap (M7824); potential first-in-class bifunctional immunotherapy 

Merck, a leading science and technology company, today announced that new research from its growing broad oncology portfolio, from immuno-oncology (IO) to DNA damage response (DDR) approaches, will be presented across a broad range of hard-to-treat cancers at this year's American Society of Clinical Oncology annual meeting (ASCO; June 2-6, Chicago). Over 40 abstracts showcase the impact of Merck's commitment to shaping cancer care today and tomorrow, including data for avelumab*, which is being developed in collaboration with Pfizer, Erbitux(R) (cetuximab), and pipeline updates on the anti-PD-L1/TGF-ss trap M7824, the DNA-PK inhibitor M3814, the BTK inhibitor M7583, and the c-Met inhibitor tepotinib**.

"We are focused on delivering innovation that matters to patients, as shown in our ASCO data that spans across IO and DDR approaches to tackle some of the hardest-to-treat cancers," said Luciano Rossetti, Executive Vice President, Head of Global Research & Development at the biopharma business of Merck. "Merck was among the first to leverage the potential of the PD1/PDL1 pathway for patients, and we continue to build on that progress with our ASCO presence and the two recent FDA accelerated approvals for avelumab."

Multiple avelumab presentations at ASCO include data in first-line metastatic Merkel cell carcinoma (mMCC) and previously treated metastatic urothelial carcinoma (UC), as well as results from the Phase Ib trial from the avelumab combination trial with axitinib in renal cell carcinoma (RCC). Recently, the U.S. Food and Drug Administration (FDA) granted accelerated approval*** for avelumab for the treatment of mMCC and pretreated patients with locally advanced or metastatic UC. Avelumab is currently being evaluated as both monotherapy and combination therapy in an extensive clinical development program. Beyond mMCC, locally advanced or metastatic UC and RCC, further avelumab abstracts in non-small cell lung cancer and metastatic castrate-resistant prostate cancer, locally advanced squamous cell carcinoma of the head and neck, relapsed or refractory diffuse large B-cell lymphoma will be showcased.

In addition to avelumab data, Merck will also feature new research at ASCO on its investigational bifunctional immunotherapy anti-PD-L1/TGF-ss trap (M7824), which is thought to simultaneously block both PD-L1 and TGF-ss. An oral presentation will showcase dose escalation Phase I clinical data exploring the potential of M7824 in advanced solid tumors.

Pipeline updates at ASCO also include early clinical results for both Tepotinib, an investigational small-molecule inhibitor of the c-Met receptor tyrosine kinase, M7583, an oral, highly selective, covalent inhibitor of Bruton's tyrosine kinase (BTK), and the first clinical data for M3814, an investigational DNA-dependent protein kinase (DNA-PK) inhibitor. Merck is investing significant resources in the promising area of DDR to be a leader in this field. Merck has recently in-licensed two promising clinical-stage programs from Vertex.

This highly focused approach to research and development channels Merck's scientific expertise in areas of high unmet need, a legacy started with Erbitux. Multiple presentations at ASCO reinforce Erbitux as a standard-of-care treatment in squamous cell carcinoma of the head and neck (SCCHN) and metastatic colorectal cancer (mCRC), providing valuable information about biomarkers, disease response, and the importance of tumor location in mCRC, to best target treatment to the right patients.

*Avelumab is under clinical investigation for treatment of NSCLC, RCC, DLBCL, SSCHN and mCRPC and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for NSCLC, RCC, DLBCL, SSCHN and mCRPC by any health authority worldwide.

**Tepotinib is the proposed nonproprietary name for the c-Met kinase inhibitor (also known as MSC2156119J).

Tepotinib, M7824 and M3814 are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

Notes to Editors 

Accepted Merck-supported key abstracts slated for presentation are listed below. In addition, a number of investigator-sponsored studies have been accepted, including multiple abstracts related to Erbitux and avelumab (not listed).

Presentation Date / Time Title Lead Author Abstract # (CDT) Location M7824 (TGF-ss trap) JL Gulley 3006 June 5 Hall D1 Oral Presentation 13:15-16:27 Solid Tumors Preliminary results from a phase 1 trial of M7824 (MSB0011359C), a bifunctional fusion protein targeting PD-L1 and TGF-beta, in advanced solid tumors


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