Pfizer’s REFLECTIONS B3271002 (ClinicalTrials.gov Identifier: NCT01989676) study evaluating PF-05280014 as a potential biomarker to trastuzumab (Herceptin) met its primary endpoint of objective response rate, according to a press release.1
In this phase 3 trial, researchers compared the safety and efficacy of PF-05280014 with paclitaxel against those of trastuzumab among patients with HER2-postive, metastatic breast cancer.
The study showed equivalence in objective response rate of PF-05280014 to Herceptin as first-line treatment in this setting.
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PF-05280014 is a monoclonal antibody being tested as a potential biomarker for Herceptin, which is approved by the U.S. Food and Drug Administration for the treatment of HER2-positive breast and gastric cancers.
- Pfizer Announces Positive Top-Line Results from the Pivotal Comparative REFLECTIONS B3271002 Study for PF-05280014, a Potential Biosimilar to Herceptin®1 (trastuzumab). Pfizer website. http://www.pfizer.com/news/press-release/press-release- detail/pfizer_announces_positive_top_line_results_from_the_pivotal_comparative_reflections_b3271002_study_for_pf_05280014_a_potential_biosimilar_to_herceptin_1_trastuzumab. Updated November 30, 2016. Accessed December 2, 2016.