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Sipavibart Trial Meets Primary Endpoints Against COVID-19

In science and medicine, information is constantly changing and may become out-of-date as new data emerge. All articles and interviews are informational only, should never be considered medical advice, and should never be acted on without review with your health care team.

SUPERNOVA is a Phase III trial looking at the safety and efficacy of sipavibart, a long-acting antibody to prevent COVID-19 infection in individuals who are immunocompromised. On May 16th, 2024, AstraZeneca published a press release to announce the trial has met its primary endpoints.

While little detail has been released to the public, we know the trial has met its two primary endpoints:

  1. Reduced the relative risk of symptomatic COVID-19 caused by any SARS-CoV-2 variant.
  2. Reduced the relative risk of infections caused by SARS-CoV-2 variants not containing the F456L mutation.

This study was occurring during a shifting landscape of different SARS-CoV-2 variants.

The SUPERNOVA trial studied sipavibart in “immunocompromised patients [including] those with blood cancer, organ transplant recipients, patients with end-stage renal disease requiring dialysis, patients receiving B-cell depleting therapy within the past year, and those taking immunosuppressive medications.”

The results will be shared with the FDA, and hopefully, vulnerable CLL / SLL patients who don’t respond well to COVID-19 vaccines will soon have a second option for pre-exposure prophylaxis (PrEP). Pemgarda is already authorized for PrEP.

For more details, please see the AstraZeneca press release: SUPERNOVA Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population

CLL Society will be meeting with the team who are responsible for sipavibart and will share what we learn.