Breakthrough Innovation in Cancer Care From Merck Pipeline to Be Presented at ASCO 2020

- Results from two studies of BAVENCIO^® to be featured in ASCO press briefing

- Primary efficacy, biomarker and HRQoL analyses for tepotinib^†, the first MET inhibitor to have received a regulatory approval for NSCLC with MET gene alterations

- Two-year follow-up for first-in-class bifunctional immunotherapy bintrafusp alfa^‡ targeting TGF-β/PD-L1, in second-line NSCLC

DARMSTADT, Germany, May 13, 2020 /PRNewswire/ -- Merck, a leading science and technology company, today announced data for its innovative investigational agents and investigational uses of marketed medicines to be presented at the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program, to be held from May 29-31.

This year ASCO will be highlighting—during its embargoed presscast on Tuesday, May 26 and at the plenary session on Sunday, May 31—the Phase III JAVELIN Bladder 100 study (Abstract# LBA1) of BAVENCIO^® (avelumab) in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC)*. Additional data will be presented for early- to late-stage molecules discovered and developed in-house that demonstrate the Company's commitment and relentless drive to discover, develop and deliver innovative treatment options in its hope to turn cancer patients into cancer survivors. Research from several investigator-sponsored and collaborative research studies also will be shared. This includes a late-breaking oral presentation of results of the investigator-sponsored, multicenter Phase II TROPHIMMUN study of avelumab for the treatment of chemotherapy-resistant gestational trophoblastic tumors (Cohort A), which also will be featured in the ASCO press program (Abstract# LBA6008).

"Despite the many advances in cancer treatment, we have an urgency to continue to discover and develop innovative treatment options that will have a major impact on the lives of people living with cancer," said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck. "Taking on this challenge, we've applied our deep knowledge of cancer biology to highly focused areas to develop the first-in-class oral MET inhibitor tepotinib, which received the first approval anywhere in the world for the treatment of NSCLC with MET gene alterations, and our first-in-class bifunctional fusion protein immunotherapy, bintrafusp alfa, both of which have promising outcomes featured at this year's ASCO meeting."

For tepotinib^†, approved in Japan for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations and the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval, data will be presented from the primary analysis of the VISION study with promising activity in patients with advanced EGFR/ALK wild-type, METex14 skipping NSCLC who were prospectively enrolled using liquid biopsy or tissue biopsy. Results (Abstract #9556) include ≥6-month follow-up data for the primary endpoint of objective response rate (ORR) as determined by independent review committee. Secondary endpoints include ORR as assessed by investigators, duration of response, disease control rate, progression-free survival, molecular responses, and safety data. Additionally, patient-reported outcomes (PROs) of health-related quality of life (HRQoL) for the VISION study will be presented at the meeting (Abstract# 9575). These outcomes are the first time HRQoL have been reported for patients with METex14 skipping NSCLC.

For bintrafusp alfa, a novel bifunctional fusion protein targeting TGF-β and PD-L1, two-year follow-up data from a global Phase I study in second-line NSCLC will be presented (Abstract# 9558). These data continue to show manageable safety with durable responses and encouraging long-term survival, especially in patients with high PD-L1 expression (≥80%). The overall safety profile has remained consistent since the interim analysis, with no new safety signals or deaths and one additional treatment-related discontinuation (blood alkaline phosphatase increased). Studies in the bintrafusp alfa lung cancer program include:

• INTR@PID LUNG 037: Adaptive Phase III, randomized, open-label controlled study of bintrafusp alfa compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced NSCLC;
• INTR@PID LUNG 005: Phase II study of bintrafusp alfa with concurrent chemoradiation therapy (cCRT) in unresectable Stage III NSCLC; and
• INTR@PID LUNG 024: Phase Ib/II, open-label study of bintrafusp alfa in combination with chemotherapy in participants with Stage IV NSCLC regardless of PD-L1 expression status.

For ERBITUX^®, the Company's first biology-driven leader, data from an investigator-sponsored study, TPExtreme (Abstract# 6507), will be highlighted in an oral presentation at the congress. These results continue to add to the large body of data reinforcing the legacy of ERBITUX^® as the cornerstone of treatment for squamous cell carcinoma of the head and neck (SCCHN).

The Company's broad portfolio of investigational DNA damage response (DDR) inhibitors represents multiple development paths, including combinations with other agents and modalities. A trial-in-progress poster (Abstract #TPS4117) will review a multicenter Phase Ib/II study evaluating the safety, tolerability, pharmacokinetics and efficacy of the DNA-PK inhibitor peposertib (formerly M3814) in combination with capecitabine and radiotherapy as neoadjuvant treatment in patients with locally advanced rectal cancer.

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC. There is no guarantee that BAVENCIO will be approved for first-line maintenance treatment of advanced UC by any health authority worldwide.

^†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. 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).

In the US, BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO^®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)

The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.

About ERBITUX^® (cetuximab)

ERBITUX^® is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX^® is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX^® also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX^® has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX^®, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

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About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck generated sales of € 16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

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