J&J Quits RSV Development With Two Rivals Already Poised For US Approval
Executive Summary
The pharma, which has been de-emphasizing vaccines and infectious disease of late, will end its Phase III trial for an RSV vaccine with May approvals pending for both Pfizer’s and GSK’s candidates.
Johnson & Johnson revealed on 29 March that it is ending development of its respiratory syncytial virus (RSV) vaccine candidate, effectively shuttering its 20,000-plus patient Phase III study mid-stream, due to the fact that competitors appear likely to beat them to the market. GSK plc and Pfizer Inc. have RSV candidates filed for approval at the US Food and Drug Administration with action dates in May. J&J said enrollment was ongoing at the time of its decision.
J&J was roughly a year behind its two peers in terms of reporting data from the pivotal EVERGREEN study. Its adult vaccine candidate is an adenovirus vector vaccine combined with a soluble protein. GSK’s candidate has a 3 May action date at FDA, while Pfizer’s candidate, filed for priority review on 7 December, also is due for an FDA decision in May. (Also see "Keeping Track: RSV Vaccine Race Heats Up Between Pfizer And GSK; Another J&J Bispecific For Myeloma" - Pink Sheet, 11 Dec, 2022.)
“When we began the pursuit of a vaccine to prevent RSV and protect vulnerable populations, including older adults, the breadth of potential options for physicians was far different than it is today,” a J&J spokesperson told Scrip.
The pharma said it is prioritizing its “most transformational assets” for continued investment and decided after reviewing the RSV prevention space, to make the RSV vaccine candidate one of the cuts in an ongoing strategic review of its R&D efforts.
The spokesperson said J&J nonetheless had “made great strides in advancing clinical and scientific knowledge through our RSV adult vaccine program.”
J&J is in the midst of a period of reshaping its research and development pipeline, which will soon be overseen by new leadership. The company recently named Sanofi R&D head John Reed head of pharmaceuticals R&D to replace interim head William Hait, effective 3 April. (Also see "J&J-Bound Reed Reaches End Of The Road As Sanofi R&D Chief" - Scrip, 13 Feb, 2023.)
Pfizer, GSK To Give US Two RSV Vaccine Options Soon
The RSV market is benefiting from a burst of innovation after decades of limited treatment options. There are currently no RSV vaccines approved in the US, but the US Centers of Disease Control and Prevention’s Advisory Committee on Immunization Practices convened in June 2022 to begin a review of five developmental candidates for preventing the virus. (Also see "RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates" - Pink Sheet, 24 Jun, 2022.) At the time, ACIP predicted that a vaccine might reach market by mid-2023.
During its third quarter 2022 earnings call in November, Pfizer emphasized the potential of its RSV candidate, the bivalent RSV prefusion F vaccine (RSVpreF) for adults 60 and older. (Also see "Pfizer Plans For COVID Transition And RSV Vaccine Launch" - Scrip, 1 Nov, 2022.) Already having reported successful data from its Phase III RENOIR study, it issued data from another Phase III trial in pregnant women, MATISSE, that showed 81.8% observed efficacy for severe medically attended lower respiratory tract illness through the first 90 days of life for the participants’ infants.
GSK reported in June 2022 that its candidate, a recombinant subunit prefusion F glycoprotein antigen (RSVPreF3) combined with its AS01 adjuvant system and a QS-21 Stimulon adjuvant licensed from Agenus Inc., met the primary endpoint in a Phase III study. (Also see "GSK Registers A Win For Older People RSV Vaccine – But Awaited Data Will Be Crucial" - Scrip, 10 Jun, 2022.) In October, it further reported that the trial showed an overall efficacy rate of 82.6% for preventing RSV lower respiratory tract disease (LRTD) in adults 60 and older. In the 12,466-patient study, seven adults receiving the vaccine went on to contract LRTD compared with 40 participants in the control arm.
Pfizer, which also has a viral treatment for RSV infections in Phase II, reported a 66.7% overall efficacy rate for its vaccine in the pivotal RENOIR trial. Both GSK’s and Pfizer’s candidates showed stronger efficacy in cases of severe LRTD, 94.1% for GSK and 85.7% for Pfizer. Both candidates got a thumbs-up from FDA advisory panel reviews. [Editor's note: This article has been corrected for the severe LRTD rates for the GSK and Pfizer candidates.]
In addition to the GSK and Pfizer vaccines, Sanofi and AstraZeneca PLC have a monoclonal antibody nirsevimab that was recently approved in Europe and is under review in the US as a preventative treatment for RSV in newborns and infants. (Also see "RSV Market Shake Up Starts As Sanofi And AZ’s Beyfortus Wins First Approval" - Scrip, 4 Nov, 2022.)