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     316  0 Kommentare European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma

    Not intended for US, Canada and UK-based media

    -- EU approval based on JAVELIN Renal 101 trial results
    demonstrating significant improvement in progression-free survival
    with BAVENCIO in combination with axitinib compared with sunitinib

    -- Combination regimen approved across all IMDC prognostic risk
    groups and irrespective of PD-L1 expression

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    Darmstadt, Germany, and New York (ots/PRNewswire) - Merck and
    Pfizer Inc. (NYSE: PFE) today announced that the European Commission
    (EC) has approved BAVENCIO® (avelumab) in combination with axitinib
    for the first-line treatment of adult patients with advanced renal
    cell carcinoma (RCC). The approval was based on positive interim
    results from the Phase III JAVELIN Renal 101 study, which
    demonstrated that BAVENCIO in combination with axitinib significantly
    lowered risk of disease progression or death by 31% (HR: 0.69 [95%
    CI: 0.574-0.825; p<0.0001]) and nearly doubled objective response
    rate (ORR; 52.5% [95% CI: 47.7-57.2] vs. 27.3% [95% CI: 23.2-31.6])
    compared with sunitinib in patients with advanced RCC regardless of
    PD-L1 status. The study included patients across International
    Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic
    risk groups. Improvement in progression-free survival (PFS) was
    observed across pre-specified subgroups in patients receiving the
    treatment combination.1 Merck and Pfizer have a global strategic
    alliance to jointly develop and commercialize BAVENCIO.

    "There is a high incidence of kidney cancer in Europe, and for the
    most common type, renal cell carcinoma, we continue to need
    additional treatment options, particularly for patients with advanced
    disease, where outcomes are poorest," said Professor James Larkin,
    Consultant Medical Oncologist at The Royal Marsden NHS Foundation
    Trust and Professor at the Institute of Cancer Research (ICR). "We've
    seen a demonstrated efficacy benefit and safety and tolerability
    profile for avelumab in combination with axitinib across all
    prognostic risk groups in patients with advanced renal cell
    carcinoma, so today's approval in Europe brings an important option
    that can help healthcare professionals optimize treatment strategies
    across risk stratification."

    In 2018, an estimated 136,500 new cases of kidney cancer were
    diagnosed in Europe, and approximately 54,700 people died from the
    disease.2 Many patients living with advanced RCC do not go on to
    receive additional treatment after first-line therapy,3,4 for reasons
    that may include poor performance status or adverse events from their
    initial treatment.3,5,6 The five-year survival rate for patients with
    advanced RCC is approximately 12%.7

    "This first European approval of an anti-PD-L1 as part of a
    combination treatment for advanced renal cell carcinoma builds on our
    commitment to bringing innovative treatment options to patients with
    hard-to-treat cancers through our extensive JAVELIN clinical trial
    program," said Rehan Verjee, Global Head of Innovative Medicine
    Franchises for the Biopharma business of Merck. "RCC is the most
    common form of kidney cancer, accounting for 90% of diagnoses. We are
    now working to make BAVENCIO in combination with axitinib available
    for patients with advanced renal cell carcinoma as quickly as
    possible."

    "The European Commission approval of BAVENCIO in combination with
    axitinib has the potential to bring even more patients with advanced
    renal cell carcinoma a new first-line treatment, and it allows us to
    continue to deliver on our more than decade-long passion to do more
    for patients with kidney cancer," said Andy Schmeltz, Global
    President, Pfizer Oncology. "We thank all of the researchers,
    doctors, advocates, patients and their families who helped get us
    here today, and we will continue in our fight against this advanced
    cancer."

    The EC's decision follows the U.S. Food and Drug Administration
    (FDA) approval of BAVENCIO in combination with axitinib for the
    first-line treatment of patients with advanced RCC in May 2019. A
    supplemental application for BAVENCIO in combination with axitinib in
    unresectable or metastatic RCC was submitted in Japan in January
    2019.

    Additionally, with this approval, the posology section of the
    Summary of Product Characteristics for BAVENCIO has been updated. The
    recommended dose of BAVENCIO as monotherapy is 800 mg administered
    intravenously over 60 minutes every 2 weeks. Administration of
    BAVENCIO should continue according to the recommended schedule until
    disease progression or unacceptable toxicity. The recommended dose of
    BAVENCIO in combination with axitinib is 800 mg administered
    intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally
    taken twice daily (12 hours apart) with or without food until disease
    progression or unacceptable toxicity.1

    Data from JAVELIN Renal 101 Study Supporting Approval

    This approval was based on interim data from the Phase III JAVELIN
    Renal 101 study, a randomized, multicenter, open-label study of
    BAVENCIO in combination with axitinib in 886 patients with untreated
    advanced or metastatic RCC with a clear cell component. The study
    included patients across risk groups (International Metastatic Renal
    Cell Carcinoma Database Consortium [IMDC]: 21% favorable, 62%
    intermediate and 16% poor; Memorial Sloan Kettering Cancer Center
    [MSKCC]: 22% favorable, 65% intermediate and 11% poor). The primary
    efficacy endpoints were progression-free survival (PFS) as assessed
    by a Blinded Independent Central Review (BICR) using RECIST v1.1 and
    overall survival (OS) in the first-line treatment of patients with
    advanced RCC who have PD-L1-positive tumors (PD-L1 expression level
    >1%). PFS based on BICR assessment per RECIST v1.1 and OS
    irrespective of PD-L1 expression, objective response (OR), time to
    response (TTR), duration of response (DOR) and safety are included as
    secondary endpoints. The study is continuing for OS.

    In the analysis, BAVENCIO in combination with axitinib
    significantly improved median PFS compared with sunitinib by more
    than five months in patients irrespective of PD-L1 expression (13.3
    months [95% CI: 11.1-15.3] vs. 8.0 months [95% CI: 6.7-9.8]). With a
    median follow-up for OS of 19 months, data for the trial's other
    endpoint of OS were immature, with 27% of deaths, and the trial is
    continuing as planned. The hazard ratio for OS in patients treated
    with BAVENCIO in combination with axitinib compared with sunitinib
    was 0.80 (95% CI: 0.616, 1.027) at the interim analysis.

    The most common adverse reactions were diarrhea (62.8%),
    hypertension (49.3%), fatigue (42.9%), nausea (33.5%), dysphonia
    (32.7%), decreased appetite (26.0%), hypothyroidism (25.2%), cough
    (23.7%), headache (21.3%), dyspnea (20.9%), and arthralgia (20.9%).

    About the JAVELIN Clinical Development Program

    The clinical development program for avelumab, known as JAVELIN,
    involves at least 30 clinical programs and more than 10,000 patients
    evaluated across more than 15 different tumor types. In addition to
    RCC, these tumor types include gastric/gastro-esophageal junction
    cancer, head and neck cancer, Merkel cell carcinoma, non-small cell
    lung cancer and urothelial carcinoma.

    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.8-10 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 Merck-Pfizer Alliance

    Immuno-oncology is a top priority for Merck and Pfizer. The global
    strategic alliance between Merck and Pfizer enables the companies to
    benefit from each other's strengths and capabilities and further
    explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody
    initially discovered and developed by Merck. The immuno-oncology
    alliance is jointly developing and commercializing BAVENCIO. The
    alliance is focused on developing high-priority international
    clinical programs to investigate BAVENCIO as a monotherapy as well as
    combination regimens, and is striving to find new ways to treat
    cancer.

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    About Merck

    Merck, a leading science and technology company, operates across
    healthcare, life science and performance materials. Around 56,000
    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 - Merck is everywhere. In 2018, Merck generated sales of
    EUR 14.8 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.

    Pfizer Inc.: Breakthroughs that change patients' lives

    At Pfizer, we apply science and our global resources to bring
    therapies to people that extend and significantly improve their
    lives. We strive to set the standard for quality, safety and value in
    the discovery, development and manufacture of health care products,
    including innovative medicines and vaccines. Every day, Pfizer
    colleagues work across developed and emerging markets to advance
    wellness, prevention, treatments and cures that challenge the most
    feared diseases of our time. Consistent with our responsibility as
    one of the world's premier innovative biopharmaceutical companies, we
    collaborate with health care providers, governments and local
    communities to support and expand access to reliable, affordable
    health care around the world. For more than 150 years, we have worked
    to make a difference for all who rely on us. We routinely post
    information that may be important to investors on our website at
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    Pfizer Disclosure Notice

    The information contained in this release is as of October 28,
    2019. Pfizer assumes no obligation to update forward-looking
    statements contained in this release as the result of new information
    or future events or developments.

    This release contains forward-looking information about BAVENCIO
    (avelumab), including a new indication approved in the European Union
    for BAVENCIO in combination with axitinib for the treatment of
    patients with advanced renal cell carcinoma, the alliance between
    Merck and Pfizer involving BAVENCIO and clinical development plans,
    including their potential benefits, that involves substantial risks
    and uncertainties that could cause actual results to differ
    materially from those expressed or implied by such statements. Risks
    and uncertainties include, among other things, uncertainties
    regarding the commercial success of BAVENCIO and axitinib; the
    uncertainties inherent in research and development, including the
    ability to meet anticipated clinical endpoints, commencement and/or
    completion dates for our clinical trials, regulatory submission
    dates, regulatory approval dates and/or launch dates, as well as the
    possibility of unfavorable new clinical data and further analyses of
    existing clinical data; risks associated with interim data; the risk
    that clinical trial data are subject to differing interpretations and
    assessments by regulatory authorities; whether regulatory authorities
    will be satisfied with the design of and results from our clinical
    studies; whether and when any drug applications may be filed for
    BAVENCIO in combination with axitinib in any other jurisdictions or
    in any jurisdictions for any other potential indications for BAVENCIO
    or combination therapies; whether and when the pending application in
    Japan for BAVENCIO in combination with axitinib may be approved and
    whether and when regulatory authorities in any jurisdictions where
    any other applications are pending or may be submitted for BAVENCIO
    or combination therapies, including BAVENCIO in combination with
    axitinib may approve any such applications, which will depend on
    myriad factors, including making a determination as to whether the
    product's benefits outweigh its known risks and determination of the
    product's efficacy, and, if approved, whether they will be
    commercially successful; decisions by regulatory authorities
    impacting labeling, manufacturing processes, safety and/or other
    matters that could affect the availability or commercial potential of
    BAVENCIO or combination therapies, including BAVENCIO in combination
    with axitinib; and competitive developments.

    A further description of risks and uncertainties can be found in
    Pfizer's Annual Report on Form 10-K for the fiscal year ended
    December 31, 2018, and in its subsequent reports on Form 10-Q,
    including in the sections thereof captioned "Risk Factors" and
    "Forward-Looking Information and Factors That May Affect Future
    Results", as well as in its subsequent reports on Form 8-K, all of
    which are filed with the U.S. Securities and Exchange Commission and
    available at www.sec.gov and www.pfizer.com.

    References

    1. BAVENCIO® (avelumab) EU SmPC. Available from:
    http://www.ema.europa.eu/ema/. Accessed October 2019.
    2. Ferlay J, Colombet M, Soerjomataram I, et al. Cancer incidence
    and mortality patterns in Europe: Estimates for 40 countries and
    25 major cancers in 2018. Eur J Cancer. 2018;103:356-387.
    3. Eggers H, Ivanyi P, Hornig M, Grünwald V. Predictive factors for
    second-line therapy in metastatic renal cell carcinoma: a
    retrospective analysis. J Kidney Cancer VHL. 2017;4(1):8-15.
    4. Motzer R, et al. Nivolumab plus Ipilimumab versus Sunitinib in
    Advanced Renal-Cell Carcinoma. The New England Journal of
    Medicine. 2018;378:1277-1290.
    5. Eichelberg C, Vervenne WL, De Santis M, et al. SWITCH: A
    randomised, sequential, open-label study to evaluate the efficacy
    and safety of sorafenib-sunitinib versus sunitinib-sorafenib in
    the treatment of metastatic renal cell cancer. Eur Urol.
    2015;68;837-847.
    6. Motzer RJ, Barrios CH, Kim TM, et al. Phase II randomized trial
    comparing sequential first-line everolimus and second-line
    sunitinib versus first-line sunitinib and second-line everolimus
    in patients with metastatic renal cell carcinoma. J Clin Oncol.
    2014;32:2765-2772.
    7. Ridge C, Pua B, Madoff D. Epidemiology and staging of renal cell
    carcinoma. Semin Intervent Radiol. 2014;31(1):3-8.
    8. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the
    landscape of cancer immunotherapy. Cancer Control.
    2014;21(3):231-237.
    9. Dahan R, Sega E, Engelhardt J, et al. Fc?Rs modulate the
    anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis.
    Cancer Cell. 2015;28(3):285-295.
    10. Boyerinas B, Jochems C, Fantini M, et al. Antibody-dependent
    cellular cytotoxicity activity of a novel anti-PD-L1 antibody
    avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res.
    2015;3(10):1148-1157.

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    ots Originaltext: Merck KGaA
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    European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma Not intended for US, Canada and UK-based media - EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with BAVENCIO in combination with axitinib compared with sunitinib - …

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