Pfizer Oncology will present new data across its oncology portfolio at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) being held from June 2-6 in Chicago.

Pfizer Inc.  will present more than 50 abstracts, involving more than 15 clinical-stage assets across solid and hematologic tumors and 12 mechanisms of action. New data will be featured in nine oral presentations from company-sponsored clinical trials, including a late-breaker on the investigational compound dacomitinib in locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutation, which will be featured in the official ASCO press program.
Other abstracts provide insights into treating lung, breast, kidney and prostate cancers and hematologic malignancies across marketed and investigational Pfizer therapies, including immuno-oncology (IO) and IO combinations. “While tremendous strides in cancer are made every day, it’s clear there is so much more to achieve on behalf of patients,” -2- -moresaid Liz Barrett, global president and general manager, Pfizer Oncology. “Through our cutting-edge science and a desire to work collaboratively, Pfizer Oncology continues to break boundaries in cancer care and is helping to redefine life with cancer.” “Our presentations at this year’s ASCO cover a broad range of drug development: from Phase 1 to Phase 3; from immunotherapy to targeted agents and antibody-drug conjugates; from disease areas in which we have extensive experience to disease areas that we are entering for the first time,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “We are very excited about sharing these results with the oncology community and working with them to realize the full potential of our medicines.”

Hematology Highlights

New clinical data from a broad range of therapies will be presented, providing insights into potential treatments for several blood cancers, including acute and chronic leukemias. Key abstracts in investigational settings include:

• Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia (CML): initial results from the phase 3 BFORE trial
• Factors associated with allogeneic hematopoietic stem cell transplantation outcomes in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin versus conventional chemotherapy

Lung Cancer Highlights

New data will be highlighted for two investigational NSCLC therapies that target EGFR and anaplastic lymphoma kinase (ALK) genetic alterations and reinforce the increasingly important role that biomarker-driven treatments are playing across lung cancers. -3- -moreKey abstracts include:

• Dacomitinib versus gefitinib for the first-line treatment of advanced EGFR mutation positive non-small cell lung cancer (ARCHER 1050): A randomized, open-label phase 3 trial
• Efficacy and safety of lorlatinib in ALK+ non-small-cell lung cancer patients with ≥1 prior ALK tyrosine kinase inhibitor: A phase I/II study

 Breast Cancer Highlights

Pfizer is also working to expand treatment options for patients with a certain type of metastatic breast cancer with talazoparib, an investigational, dual-mechanism PARP inhibitor. Results from a Phase 2 study of talazoparib will be presented. In addition, updated overall survival data from the PALOMA-1 study of IBRANCE® (palbociclib) will be shared. Key abstracts include:

• Results of a phase 2 study of talazoparib following platinum or multiple cytotoxic regimens in advanced breast cancer patients with germline BRCA1/2 mutations (ABRAZO)
• Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole vs letrozole alone for first-line treatment of ER+/HER2– advanced breast cancer (PALOMA-1; TRIO-18)

Renal Cell Carcinoma Highlights

For the past 10 years, Pfizer has been a leader in developing new treatments for patients with advanced kidney cancer. Building on this experience, Pfizer is sharing early data from a novel immuno-therapy combination with INLYTA® (axitinib) and PD-L1 inhibitor avelumab in advanced renal cell carcinoma (RCC), being developed in collaboration with Merck KGaA, Darmstadt, Germany. -4- -moreFurther, a sub-analysis from the use of SUTENT® (sunitinib) in the adjuvant RCC setting will also be presented. Key abstracts in investigational settings include:

• • First-line avelumab + axitinib therapy in patients with advanced renal cell carcinoma (aRCC): results from a phase 1b trial
  • A phase 3 trial of adjuvant sunitinib in patients with high-risk renal cell carcinoma (RCC): validation of the 16- gene Recurrence Score in stage III patients

Prostate Cancer Highlights

New clinical data provide insights into combination of agents most likely to benefit patients with metastatic castrationresistant prostate cancer (CRPC) following PSA progression with enzalutamide, adding to the robust and rigorous clinical trial program of XTANDI® (enzalutamide) in metastatic CRPC and other prostate cancer populations. Key abstracts include:

• A phase 4, randomized, double-blind, placebo-controlled study of continued enzalutamide post prostate-specific antigen progression in men with chemotherapy-naïve metastatic castration-resistant prostate cancer

For a complete list of Pfizer-sponsored abstracts featuring data on our broad pipeline of biologics and small molecules, please visit: Pfizer website
Learn more about how Pfizer Oncology is applying innovative approaches to improve the outlook for people living with cancer at http://www.pfizer.com/research/therapeutic_areas/oncology.
Additionally, Pfizer and Astellas announced the discontinuation of the planned ENDEAR trial (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer); no patients were ever enrolled in the trial. Furthermore, the companies have decided that based on the data from the enzalutamide Phase 2 HER2+ and ER/PR+ breast cancer studies, there will not be follow-on Phase 3 studies at this time.