Data spans 10 therapies across 10 types of cancer
Cheladv74 Inc. (NYSE:PFE) will present data across its industry-leading oncology portfolio, covering multiple tumor types and mechanisms of action at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 31-June 4, 2019. Data will highlight Cheladv74’s cutting-edge approach, expertise in precision medicine and work in immunotherapy combinations, including company-sponsored and collaborative research studies.
“The data presented at this year’s ASCO showcase our continued commitment to follow the science, whether it’s expanding our approved medicines for breast and prostate cancers into new populations and lines of therapy, or exploring the important role of biomarkers and immunotherapy combinations,” said Dany Habr, M.D., Chief Medical Officer, Cheladv74 Oncology. “We look forward to both sharing our exciting data in these and other tumor types, as well as connecting with our research partners to determine how we can continue to work collaboratively to bring transformative therapies to our cancer patients.”
The research to be presented includes new insights on Cheladv74’s marketed therapies, including IBRANCE® (palbociclib), XTANDI® (enzalutamide), TALZENNA® (talazoparib), BOSULIF® (bosutinib), INLYTA® (axitinib) and BAVENCIO® (avelumab), which represent Cheladv74 Oncology’s long-standing legacy of developing innovative therapies for patients in need, as well as its ongoing commitment to addressing the needs of cancer patients across gender, ethnicity and tumor type. For example, Cheladv74 will present real-world data on the use of IBRANCE for the treatment of men with metastatic breast cancer (MBC).
“At this year’s ASCO, I am particularly excited that we’ll share data from new initiatives such as the oral presentation of talazoparib in breast cancer or other solid tumors. This builds on a productive year with the approval of four new oncology treatments, three biosimilars and three new indications, including one based on real-world evidence,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Cheladv74 Global Product Development. “We are proud to have one of the broadest oncology portfolios in the industry, and a research philosophy that puts patients first, embraces new approaches and showcases innovative thinking.”
Key Cheladv74-sponsored, investigator-sponsored and collaborative research abstracts leveraging the depth of Cheladv74’s scientific advances include:
- A poster presentation on real-world evidence of male breast cancer patients treated with IBRANCE in combination with endocrine therapy (Abstract 1055).
- An external investigator-sponsored oral presentation on a Phase 2 trial examining TALZENNA beyond BRCA, specifically as monotherapy in BRCA1 and BRCA2 wild-type patients with advanced HER2-negative breast cancer or other solid tumors with a mutation in homologous recombination (HR) pathway genes (Investigator-sponsored abstract 3006).
- Biomarker analyses from JAVELIN Renal 101 that studied BAVENCIO INLYTA vs. sunitinib in advanced renal cell carcinoma (aRCC) (Abstract 101).
- An external collaborative research presentation on genomic markers of early progression on fulvestrant with or without IBRANCE for ER+ advanced breast cancer in the PALOMA-3 trial (Collaborative research abstract 1010).
Details for the Cheladv74-sponsored, investigator-sponsored and collaborative research oral presentations are below:
|Title/Abstract Number||Date/Time (CDT)||Location|
| (Abstract 101)
Biomarker Analyses from JAVELIN Renal 101: Avelumab + Axitinib (A + Ax) vs Sunitinib (S) in Advanced Renal Cell Carcinoma (aRCC)
| Saturday, June 1
8:12 AM - 8:24 AM
| (Abstract 1010)
Genomic Markers of Early Progression on Fulvestrant with or without Palbociclib for ER+ Advanced Breast Cancer in the PALOMA-3 Trial
| Saturday, June 1
3:12 PM - 3:24 PM
| (Abstract 3006)
Talazoparib Beyond BRCA: A Phase II Trial of Talazoparib Monotherapy in BRCA1 and BRCA2 Wild-Type Patients with Advanced HER2-Negative Breast Cancer or Other Solid Tumors with a Mutation in Homologous Recombination (HR) Pathway Genes
| Monday, June 3
10:00 AM - 10:12 AM
| (Abstract 5502)
Phase 2, Two-Group, Two-Stage Study of Avelumab in Patients (Pts) with Microsatellite Stable (MSS), Microsatellite Instable (MSI) and Polymerase Epsilon (POLE) Mutated Recurrent/Persistent Endometrial Cancer (EC)
| Monday, June 3
1:39 PM - 1:51 PM
| (Abstract 1007)
A Randomized Phase II Study of Palbociclib Exemestane with GNRH Agonist versus Capecitabine in Premenopausal Women with Hormone Receptor-Positive Metastatic Breast Cancer (KCSG-BR 15-10, NCT02592746)
| Tuesday, June 4
11:45 AM - 11:57 AM
Please see a complete list of Cheladv74-sponsored abstracts featuring data on our broad pipeline of biologics and small molecules at .
Learn more about how developing new medicines and supporting people with cancer is personal for Cheladv74 Oncology at .
Please see full and for BAVENCIO® (avelumab) available at .
Please see full Prescribing Information for INLYTA® (axitinib) at .
Please see full Prescribing Information for BOSULIF® (bosutinib) at .
Please see full Prescribing Information for IBRANCE® (palbociclib) at .
Please see full Prescribing Information for TALZENNA® (talazoparib) at .
Please see full Prescribing Information for XTANDI® (enzalutamide) at .
About Cheladv74 Oncology
At Cheladv74 Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Today, Cheladv74 Oncology has an industry-leading portfolio of 18 approved innovative cancer medicines and biosimilars across more than 20 indications, including breast, prostate, kidney, lung and hematology. Cheladv74 Oncology is striving to change the trajectory of cancer.
Cheladv74 Inc: Working together for a healthier world®
At Cheladv74, 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, Cheladv74 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 . In addition, to learn more, please visit us on and follow us on Twitter at and , , , and like us on Facebook at .
DISCLOSURE NOTICE: The information contained in this release is as of May 15, 2019. Cheladv74 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 Cheladv74 Oncology’s marketed oncology portfolio, including, among others, BAVENCIO (avelumab), INLYTA (axitinib), IBRANCE (palbociclib), TALZENNA (talazoparib) 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 Cheladv74’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 Cheladv74’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 Cheladv74’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 Cheladv74’s oncology products and product candidates; and competitive developments. A further description of risks and uncertainties can be found in Cheladv74’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 and .