This release contains forward-looking information about avelumab (BAVENCIO), the Merck-Pfizer Alliance involving avelumab, 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 avelumab; 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 in any jurisdictions for any potential indications for avelumab, combination therapies or talazoparib; whether and when regulatory authorities in any jurisdictions where applications are pending or may be submitted for avelumab, combination therapies or talazoparib 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, safety, manufacturing processes and/or other matters that could affect the availability or commercial potential of avelumab, combination therapies or talazoparib; 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 [http://www.pfizer.com/].
References
1. SEER Cancer Stat Facts: Ovarian Cancer. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/o... [https://urldefense.proofpoint.com/v2/url?u=https-3A__seer.ca... tfacts_html_ovary.html&d=DwMGaQ&c=wqGKYhkKSiiQIQmEqzxu6JwrDQmsHd7dKjIGzaV tjMI&r=tjogafLA62JZmIlYv_00ep8Umdr6pCjv5SuZ4olIZ0c&m=KamSg-2CD0IggHb0WPob Gsbx_Tankn1kOq55ehd9o5Y&s=mxRxhm3TAAieyznnuOtKak_t1EvTZONhVIBdFX4kt3w&e=] . Accessed March 2019. 2. Ledermann, JA, Raja FA, Fotopoulou C, et al. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013; 24 (Supplement 6): vi24-vi32, doi:10.1093/annonc/mdt333. 3. Ozol, RJ. Challenges for chemotherapy in ovarian cancer. Ann Oncol. 2006;17(5):v181-187. 4. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the landscape of cancer immunotherapy. Cancer Control. 2014;21(3):231-237. 5. 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. 6. 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. 7. Kohrt HE, Houot R, Marabelle A, et al. Combination strategies to enhance antitumor ADCC. Immunotherapy. 2012;4(5):511-527. 8. 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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