This release contains forward-looking information about BAVENCIO (avelumab), including a potential new indication for BAVENCIO in combination with INLYTA (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; 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 ofunfavorablefurther analyses of existing clinical data and uncertainties regarding whether the other primary endpoint of JAVELIN Renal 101 will be met; 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 INLYTA for the potential new indication in any other jurisdictions or in any jurisdictions for any other potential indications for BAVENCIO or combination therapies; whether and when the pending applications in the U.S. and Japan for BAVENCIO in combination with INLYTA for the potential new indication 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 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 impactinglabeling, manufacturing processes and/or other matters that could affect the availability or commercial potential of BAVENCIO or combination therapies, including BAVENCIO in combination with INLYTA for the potential new 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, 2017, 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 atwww.sec.gov [https://urldefense.proofpoint.com/v2/url?u=http-3A__www.sec.... ] andwww.pfizer.com [https://urldefense.proofpoint.com/v2/url?u=http-3A__www.pfiz... ] .
References
1) National Cancer Institute: SEER Stat Fact Sheets: Kidney and renal pelvis. Available from: http://seer.cancer.gov/statfacts/html/ki.... Accessed February 2019. 2) LjungbergB, Campbell S and Cho H. The Epidemiology of Renal Cell Carcinoma.EurUrol. 2011;60:615-621. 3) American Cancer Society. What is kidney cancer? Available from: https://www.cancer.org/cancer/kidney-cancer/about.html. Accessed February 2019. 4) EscudierB, Porta C,SchmidingerM et al Renal cell carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up.AnnalOncol. 2014; 25(Suppl3) :iii49-iii56. 5) American Cancer Society. Cancer facts and figures 2019. Available at:https://www.cancer.org/content/dam/cancer-org/research/cance... s/annual-cancer-facts-and-figures/2019/cancer-facts-and-figures-2019.pdf [https://urldefense.proofpoint.com/v2/url?u=https-3A__www.can... ] . Accessed February 2019 6) Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of cancer immunotherapy. Cancer Control. 2014;21(3):231-237. 7) DahanR, Sega E,EngelhardtJ, Selby M,KormanAJ,RavetchJV.FcgammaRsmodulate the anti-tumoractivity of antibodies targeting the PD-1/PD-L1 axis. Cancer Cell. 2015;28 (3):285-295. 8) BoyerinasB,JochemsC,FantiniM, et al. Antibody-dependent cellular cytotoxicity activity of a novel anti-PD-L1 antibody avelumab (MSB0010718C) on humantumorcells. CancerImmunolRes. 2015;3(10):1148-1157. 9) KohrtHE,HouotR,MarabelleA, et al. Combination strategies to enhance antitumor ADCC. Immunotherapy. 2012;4(5):511-527. 10) Hamilton G,RathB. Avelumab: combining immune checkpoint inhibition and antibody-dependent cytotoxicity. ExpertOpinBiolTher. 2017;17(4):515-523.
Merck:
Media Relations: +49-151-1454-6328 friederike.segeberg@merckgroup.com
Investor Relations: +49-6151-72-3321 investor.relations@merckgroup.com
Pfizer:
Media Relations: +1-212-733-6213 jessica.m.smith@pfizer.com
Investor Relations: +1-212-733-8160 ryan.crowe@pfizer.com
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