P.P. and Astellas Pharma Inc. announced that on January 26 the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEV®? (enfortumab vedotin) with KEYTRUDA®? (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

The Type II variation application for first-line use of the combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). Enfortumab vedotin in combination with pembrolizumab is being investigated in an extensive program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in MIBC in EV-304 (NCT04700124), also known as KEYNOTE-B15) and EV-303 (NCT03924895, also known as KEYNOTE-905). Patients with baseline hemoglobin A1C 8% were excluded from clinical trials.

In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; R risks and uncertainties include, among other things, uncertainties regarding the commercial success of PADCEV; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for 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 and when drug applications may be filed in particular jurisdictions for PADCEV with pembrolizumib or as a single agent; whether and when any applications that may be pending or filed for PADCEV with PADCEV with p Embrolizumab, including the Type II variation application, or as a single agent, 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 PADCEV with pemrolizumab or as a single agent 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 PADCEV with pEmbrolizumab or as an single agent; whether the collaboration between Pfizer, Astellas and Merck will be successful; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.