Data span 13 therapies across 16 types of cancer aimed at transforming patient care
Pfizer Inc. today announced that new data from its diversified portfolio of marketed and investigational oncology medicines will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 1-5, 2018. Data from programs in small molecules, immunotherapies, biomarker-driven medicines, as well as biosimilars, will be featured in more than 40 abstracts, including company-sponsored and collaborative research studies.
“The breadth and depth of our data at ASCO this year are indicative of our focus on understanding the full potential of our medicines, including IBRANCE® and XTANDI®, which are already making a difference in patient lives. We are also exploring new and exciting pathways designed to transform treatment outcomes,” said Charles Hugh-Jones, MD, FRCP, chief medical officer, Pfizer Oncology. “Our comprehensive research is resulting in near-term potential benefits for patients, as well as multiple new therapies that we hope to introduce this year.”
The research to be presented includes new insights on Pfizer’s late-phase investigational compounds dacomitinib, lorlatinib, talazoparib and glasdegib, as well as Pfizer’s marketed therapy XTANDI® (enzalutamide). These compounds represent the next five potential Pfizer Oncology advancements in lung, breast, hematologic and prostate cancers.
“At this year’s ASCO, we’re particularly excited to present overall survival data for dacomitinib that builds upon our precision medicine focus and legacy in lung cancer,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “Further, we’ll be sharing new insights on our medicines across 16 disease areas and 13 mechanisms of action, including early-phase through post-approval analyses. Our extensive presence reinforces our commitment to speeding accessible breakthrough medicines to patients.”
Key Pfizer abstracts include:
The first presentation of final overall survival results from the pivotal ARCHER 1050 study of dacomitinib vs. gefitinib in locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutation
Phase 2 results from a clinical research collaboration evaluating IBRANCE® (palbociclib) in combination with cetuximab in platinum-resistant HPV unrelated recurrent/metastatic head and neck squamous cell carcinoma
An analysis of resistance to therapy based on genetic mutations from the pivotal PALOMA-3 trial of CDK 4/6 inhibitor IBRANCE in combination with fulvestrant in ER+/HER2- metastatic breast cancer
Longer-term efficacy and safety results from two registrational trials: the JAVELIN Merkel 200 study of PD-L1 inhibitor BAVENCIO® (avelumab) in a rare skin cancer, being developed in collaboration with Merck KGaA, Darmstadt, Germany and the BFORE trial of BOSULIF® (bosutinib) vs. imatinib in patients with newly diagnosed chronic myeloid leukemia
A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced non-squamous non-small cell lung cancer
Details for the Pfizer-sponsored oral presentations are below:
|Title/Abstract Number||Date/Time (CDT)||Location|
|(Abstract 9008)||Friday, June 1||Hall D1|
|Avelumab (anti-PD-L1) in Combination with Crizotinib or Lorlatinib in Patients with Previously Treated Advanced NSCLC: Phase 1b Results from JAVELIN Lung 101||4:30 PM – 6:00 PM|
|(Abstract 7002)||Saturday, June 2||E450|
|Bosutinib vs Imatinib for Newly Diagnosed Chronic Myeloid Leukemia in the BFORE Trial: 24-Month Follow-Up||3:00 PM – 6:00 PM|
|(Abstract 1001)||Sunday, June 3||Hall D2|
|Genetic Landscape of Resistance to CDK4/6 Inhibition in Circulating Tumor DNA (ctDNA) Analysis of the PALOMA3 Trial of Palbociclib and Fulvestrant Versus Placebo and Fulvestrant||8:00 AM – 11:00 AM|
|(Abstract 6008)||Sunday, June 3||E451|
Multicenter Phase 2 Trial of Palbociclib, a Selective Cyclin Dependent Kinase (CDK) 4/6 Inhibitor, and Cetuximab in Platinum-Resistant HPV Unrelated (-) Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)
|8:00 AM – 11:00 AM|
|(Abstract 9507)||Monday, June 4|
Arie Crown Theater
|Two-Year Efficacy and Safety Update from JAVELIN Merkel 200 Part A: A Registrational Study of Avelumab in Metastatic Merkel Cell Carcinoma Progressed on Chemotherapy||8:00 AM – 11:00 AM|
|(Abstract 109)||Monday, June 4||Hall D1|
|A Comparative Clinical Study of PF-06439535, a Candidate Bevacizumab Biosimilar, and Reference Bevacizumab, in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer||9:45 AM – 11:15 AM|
|(Abstract 9004)||Monday, June 4||Hall B1|
|Dacomitinib (daco) Versus Gefitinib (gef) for First-Line Treatment of Advanced NSCLC (ARCHER 1050): Final Overall Survival (OS) Analysis||3:00 PM – 6:00 PM|
Please see a complete list of Pfizer-sponsored abstracts featuring data on our broad pipeline of biologics and small molecules at https://www.pfizer.com/files/news/asco/Pfizer-Oncology-Data-Presentation....
Learn more about how developing new medicines and supporting people with cancer is personal for Pfizer Oncology at http://www.pfizer.com/research/therapeutic_areas/oncology.
Dacomitinib, lorlatinib, talazoparib and glasdegib are investigational agents and have not been approved by any regulatory agencies.
Please see full Prescribing Information for BAVENCIO® (avelumab) at www.Bavencio.com.
Please see full Prescribing Information for BOSULIF® (bosutinib) at www.Bosulif.com.
Please see full Prescribing Information for IBRANCE® (palbociclib) at www.Ibrance.com.
Please see full Prescribing Information for XTANDI® (enzalutamide) at www.Xtandi.com.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on people living with cancer. Our growing pipeline of biologics, small molecules, and immunotherapies is focused on identifying and translating the best scientific breakthroughs into clinical application for patients across a diverse array of solid tumors and hematologic cancers. Today, we have 10 approved oncology medicines and 14 assets currently in clinical development. By maximizing our internal scientific resources and collaborating with other companies, government and academic institutions, as well as patients and non-profit and professional organizations, we are bringing together the brightest and most enterprising minds to take on the toughest cancers. Together we can accelerate breakthrough treatments to patients around the world and work to redefine life with cancer.
Working together for a healthier world®
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. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. 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 16, 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 Pfizer Oncology’s marketed and investigational oncology portfolio, including, among others, dacomitinib, lorlatinib, talazoparib, glasdegib and XTANDI (enzalutamide), 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, without limitation, the ability to meet anticipated clinical trial commencement and 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, 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 drug applications may be filed in any jurisdictions for any potential indication for Pfizer’s oncology products and product candidates; whether and when applications that are pending or any such other applications that may be filed for any of Pfizer’s oncology products and product candidates may be approved by regulatory authorities, 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, and, if approved, whether any such oncology products will be commercially successful; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Pfizer’s oncology products and product candidates; 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 at www.sec.gov and www.pfizer.com.