Pfizer Provides Update on Phase 3 Trial of Axitinib as Adjuvant Treatment for Patients at High Risk of Renal Cell Carcinoma Recurrence After Surgery
The most common (≥10%) grade 3/4 AEs occurring in patients receiving INLYTA (vs sorafenib) were hypertension (16% vs 11%), diarrhea (11% vs 7%), and fatigue (11% vs 5%).
The most common (≥20%) lab abnormalities occurring in patients receiving INLYTA (all grades, vs sorafenib) included increased creatinine (55% vs 41%), decreased bicarbonate (44% vs 43%), hypocalcemia (39% vs 59%), decreased hemoglobin (35% vs 52%), decreased lymphocytes (absolute) (33% vs 36%), increased ALP (30% vs 34%), hyperglycemia (28% vs 23%), increased lipase (27% vs 46%), increased amylase (25% vs 33%), increased ALT (22% vs 22%), and increased AST (20% vs 25%).
For more information and full Prescribing Information, visit www.INLYTA.com.
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DISCLOSURE NOTICE: The information contained in this release is as of April 10, 2018. 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 INLYTA (axitinib), including its 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 impact of the Phase 3 ATLAS trial results; the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations; 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 INLYTA in combination with immune checkpoint inhibitors in any jurisdictions; whether and when regulatory authorities may approve any such applications, which will depend on the assessment by such regulatory authority of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether INLYTA will be commercially successful; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of INLYTA; 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 its subsequent reports of 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.
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1 Pfizer data on file.
2 Ferlay J, Shin HR, Bray F.GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 Lyon, France: International Agency for Research on Cancer; 2010. Available at: http://globocan.iarc.fr(link is external). Accessed April 2018.
3 Ljungberg B, Campbell S and Choi H. The Epidemiology of Renal Cell Carcinoma. Eur Urol. 2011;60:615-621.
4 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 April 2018.
5 What is Kidney Cancer. James Whale Fund for Kidney Cancer. Available at: http://www.jameswhalefund.org/kidneycancer/what-is-kidney-cancer/(link is external). Accessed April 2018.
6 Based on comparison between 2015 Swedish population study (76%), Navigant interviews (95%), and Quant Pulse (79%). 2018-2022.
7 The Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI). Cancer Stat Facts: Kidney and Renal Pelvis Cancer. https://seer.cancer.gov/statfacts/html/kidrp.html. Accessed April 2018.
Jessica Smith, 212-733-6123
Ryan Crowe, 212-733-8160
Stewart Hallett, 925-201-1003
Source: Pfizer Inc.