Phase III results for 20vPnC vaccine for pneumococcal disease.- Pfizer

Pfizer Inc. announced top-line results from one of its Phase III studies (NCT03760146), which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease. The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at one month after vaccination were met for all serotypes in common with licensed Prevnar 13 (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23); one of the new seven serotypes missed noninferiority criteria by a small margin. Secondary immunogenicity objectives for adults 18-59 years old compared to those 60-64 years old met non-inferiority for all 20 serotypes. The safety objectives were met in adults 18 years of age or older demonstrating that the safety and tolerability of 20vPnC were comparable to licensed pneumococcal vaccines. Based on prior discussions with regulators, these data are expected to meet licensure criteria. Pfizer’s 20vPnC vaccine candidate includes 13 serotypes already included in Prevnar 13. The seven new serotypes included in 20vPnC are global causes of invasive pneumococcal disease (IPD), and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis. Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually.15 Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally. 20vPnC Phase III Adult Program: Pfizer’s phase III pivotal development program for 20vPnC includes three clinical trials (NCT03760146, NCT03828617, and NCT03835975) evaluating the vaccine candidate for the prevention of invasive disease and pneumococcal pneumonia in adults 18 years or older. Combined, these three trials have enrolled more than 6,000 adult subjects, including populations of vaccine-naïve adults and adults with prior pneumococcal vaccination. All three trials have been completed and the data for two remaining studies will be reading out over the next few months. This press release refers to NCT03760146: Phase III randomized, double-blind trial including 3,880 adults aged 18 or older with no history of pneumococcal vaccination. The study was designed to compare immune responses in patients greater than 60 years old after 20vPnC administration to responses in a control group receiving Prevnar 13 or PPSV23. The study also evaluated immune responses of 20vPnC in adults 18 to 59 years (secondary endpoints) and described the safety profile of 20vPnC in all adults greater than 18 years old (primary endpoint). Additional trials include : NCT03828617: Phase III randomized, double-blind trial, designed to provide additional safety data and evaluate three different lots of 20vPnC in adults 18 through 49 years of age with no history of pneumococcal vaccination. More on the study can be found on www.clinicaltrials.gov under the identifier NCT03828617. NCT03835975: Phase III randomized, open-label trial, designed to describe the safety and immune response of 20vPnC in an estimated 875 adults aged 65 years or older with prior pneumococcal vaccination. More on the study can be found on www.clinicaltrials.gov under the identifier NCT03835975. On September 20, 2018, Pfizer announced the FDA granted Breakthrough Therapy Designation for 20vPnC for the prevention of invasive disease and pneumonia in adults age 18 years or older. Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, which may include more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.