Data spans targeted and immuno-therapies across 17 cancer types
JAVELIN Bladder 100 Study to be presented in Plenary Session and featured in the official Press Program
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO20 Virtual Scientific Program, from May 29-May 31. The data that will be presented build on Pfizer’s strong track record in oncology by providing new insights in areas like breast, colorectal and genitourinary cancers, which include bladder, prostate, and kidney cancer. Data from Pfizer’s early stage pipeline, including a novel anti-HER2 antibody-drug conjugate, will also be presented as Pfizer aims to transform the cancer treatment landscape well into the future.
“Our data presentations will highlight the depth and breadth of our cancer portfolio, including our current medicines and new generation of potential therapies,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We are particularly excited to share the first presentation of detailed overall survival results from the JAVELIN Bladder 100 trial of BAVENCIO and the final overall survival data from the PROSPER trial of XTANDI. These data will support our rapidly expanding efforts in bladder cancer and add to the growing body of clinical evidence generated with XTANDI in prostate cancer.”
New data will be featured in nine oral presentations, including a Plenary Session presentation of data from the JAVELIN Bladder 100 trial evaluating BAVENCIO® (avelumab) as a first-line maintenance treatment for locally advanced or metastatic urothelial carcinoma (UC). Additional data provide insights on Pfizer’s medicines, including IBRANCE® (palbociclib), BRAFTOVI® (encorafenib), XTANDI® (enzalutamide) and lorlatinib, as well as its cutting-edge, investigational compounds, including a HER2-targeted antibody-drug conjugate in patients with solid tumors. BAVENCIO is being developed and commercialized in collaboration with Merck KGaA, Darmstadt, Germany. As part of a global agreement, Pfizer and Astellas jointly develop and commercialize XTANDI.
To help interested non-scientists better understand the latest research, Pfizer has also developed summaries in non-technical language for results of company-sponsored studies being presented in the ASCO20 Virtual Scientific Program called “abstract plain language summaries (APLS).” Those interested in learning more can visit www.Pfizer.com/apls to access the summaries directly starting May 29.
Key presentations featuring Pfizer medicines in the ASCO20 Virtual Scientific Program include:
Plenary Session Oral Presentation (Abstract LBA1)
Sunday, May 31, 1 pm ET
Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase 3 interim analysis.
Oral Presentation (Abstract 4001)
Encorafenib plus cetuximab with or without binimetinib for BRAF V600E metastatic colorectal cancer: updated survival results from a randomized, three-arm, phase 3 study versus choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC)
Poster Discussion (Abstract 5515)
Final overall survival (OS) from PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (nmCRPC)
Poster Presentation (Abstract 1039)
A phase 1 dose escalation study evaluating the safety and tolerability of a novel anti-HER2 antibody-drug conjugate (PF-06804103) in patients with HER2-positive solid tumors
Poster Presentation (Abstract 5080)
Axitinib plus pembrolizumab in patients with advanced renal cell carcinoma: Long term efficacy and safety from a phase 1b study
Investigator Sponsored Studies and Clinical Research Collaborations
Oral Presentation (Abstract 1010)
Prognostic impact of ESR1 mutations in ER+ HER2- MBC patients prior treated with first line AI and palbociclib: An exploratory analysis of the PADA-1 trial
Oral Presentation (Abstract 10504)
Phase 1 trial of lorlatinib in patients with ALK-driven refractory or relapsed neuroblastoma: A New Approaches to Neuroblastoma Consortium study
Oral, poster discussion, and poster sessions, as well as track-based clinical science symposia, will be available on demand for registered participants beginning Friday, May 29 at 8:00 AM ET. A complete list of Pfizer-sponsored abstracts is available at https://www.pfizer.com/news/press-kits/oncology.
Merck KGaA, Darmstadt, Germany, and Pfizer have a global strategic alliance to jointly develop and commercialize BAVENCIO.
As part of a global agreement, Pfizer and Astellas jointly develop and commercialize XTANDI. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.
Prescribing Information for Pfizer Medicines
Please see full Prescribing Information for BRAFTOVI® (encorafenib) at www.braftovihcp.com.
Please see full Prescribing Information for IBRANCE® (palbociclib) at www.Ibrance.com.
Please see full Prescribing Information for INLYTA® (axitinib) at www.Inlyta.com.
Please see full Prescribing Information for LORBRENA® (lorlatinib) at www.Lorbrena.com.
Please see full Prescribing Information for XTANDI® (enzalutamide) at www.Xtandi.com.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 22 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, prostate, kidney and lung cancers, as well as leukemia and melanoma.
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 www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of May 12, 2020. 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 Pfizer’s oncology portfolio of marketed and investigational therapies, including BAVENCIO (avelumab), BRAFTOVI (encorafenib), IBRANCE (palbociclib), INLYTA (axitinib), lorlatinib and XTANDI (enzalutamide) and an anti-HER2 antibody-drug conjugate, 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 Pfizer’s oncology portfolio; 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; 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 drug applications may be filed in any jurisdictions for any potential indication for Pfizer’s oncology products and product candidates; whether and when any such applications that may be pending or filed may be approved by regulatory authorities, 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 any such products 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 Pfizer’s oncology products and product candidates; the impact of COVID-19 on our business, operations and financial results; 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, 2019 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.