COMUNICADO: FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma (3

Publicado 21/12/2017 19:10:54CET

The information contained in this release is as of December 21, 2017. 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 potential indication for avelumab in combination with INLYTA (axitinib) for the treatment of advanced renal cell carcinoma (the "Potential Indication"), the Merck-Pfizer Alliance involving anti-PD-L1 and anti-PD-1 therapies, 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; the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; 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 in any jurisdictions for the Potential Indication or for any other potential indications for BAVENCIO, combination therapies or other product candidates; whether and when regulatory authorities in any jurisdictions where applications may be submitted for the Potential Indication or where applications are pending or may be submitted for BAVENCIO, combination therapies or other product candidates may approve any such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of BAVENCIO, combination therapies or other product candidates, including the Potential Indication; 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, 2016, 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 http://www.sec.gov and http://www.pfizer.com.

References 

1) American Cancer Society. What is kidney cancer? Available from: http://www.cancer.org/cancer/kidneycancer/detailedguide/kidney-cancer-adult-what-iskidney-cancer . Accessed November 2017. 2) National Cancer Institute: SEER Stat Fact Sheets: Kidney and Renal Pelvis. Available from: http://seer.cancer.gov/statfacts/html/kidrp.html. Accessed November 2017. 3) American Cancer Society. What are the key statistics about kidney cancer? Available from: https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html. Accessed November 2017. 4) Ljungberg B, Campbell S, Cho H. The Epidemiology of Renal Cell Carcinoma. Eur Urol. 2011;60:615-621. 5) Escudier B, et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;24(5):v58-v68. 6) World Cancer Research Fund International: Kidney Cancer statistics. Available from: http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/kidney-cancer-statistics . Accessed November 2017. 7) International Agency for Research on Cancer (IARC)/World Health Organization. GLOBOCAN 2012: Kidney, adults. Available from: http://globocan.iarc.fr/old/bar_-sex_site_prev.asp?selection=10210&title=Kidney&statistic=3&populations=6&window=1&grid=1&color1=5&color1e=&color2=4&color2e=&submit=%C2%A0Execute . Accessed March 2016. 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. FcgammaRs 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. 11) Kohrt HE, Houot R, Marabelle A, et al. Combination strategies to enhance antitumor ADCC. Immunotherapy. 2012;4(5):511-527. 12) Hamilton G, Rath B. Avelumab: combining immune checkpoint inhibition and antibody-dependent cytotoxicity. Expert Opin Biol Ther. 2017;17(4):515-523.

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