Patient support

Primary immunobridging results against JN.1 in Cohort A

Immunobridging is based on the serum neutralization titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for Emergency Use Authorization (EUA). To support immunobridging, serum neutralization titer was utilized to compare PEMGARDA® to previous mAbs.¹

Immunobridging would be established if the lower limit of the 2-sided 90% CI of the ratio of the geometric mean titer value is greater than 0.8.¹

PEMGARDA neutralizing antibody titers were compared to historical titers of the reference monoclonal antibody adintrevimab

The geometric mean ratio between the calculated titer for PEMGARDA against JN.1 (based on a pseudotyped VLP neutralization assay EC₅₀ value of 74.6 ng/mL) and the calculated titer for adintrevimab against Delta (based on an authentic virus neutralization assay EC₅₀ value of 7 ng/mL) was 0.70 (90% CI: 0.68-0.72).

PEMGARDA neutralizing antibody titers were compared to the titers of 3 reference monoclonal antibodies with clinical efficacy against mild-to-moderate COVID-19

The range of titers achieved with PEMGARDA for 3 months following administration of 4500 mg IV were consistent with the titer levels associated with clinical efficacy in prior clinical trials evaluating certain monoclonal antibodies for the prevention of COVID-19.

COHORT A RESULTS

Exploratory clinical efficacy results

Exploratory objectives of CANOPY evaluated rates of RT-PCR–confirmed COVID-19, COVID-19–related hospitalizations, or all-cause death in participants in both cohorts.¹

In Cohort A (adults with moderate-to-severe immune compromise), no COVID-19–related hospitalizations occurred through Month 6.
Two all-cause deaths (one due to an unknown cause and one due to suicide) occurred through Month 6.¹

Time to event (RT-PCR–confirmed symptomatic COVID-19) analysis Cohort A^2,*

*Cumulative incidence of RT-PCR–confirmed COVID-19, COVID-19–related hospitalization, and all-cause mortality through day 180 for Cohort A, the full analysis set. Participants who did not have the defined event on or before the above censoring date were censored at the earliest of the end-of-study date, 180-day follow-up, date of participant’s receipt of COVID-19 vaccine, or analysis cutoff date. One participant in Cohort A who received a postdose COVID-19 vaccine was censored at the time of vaccination.

COHORT B RESULTS

Exploratory clinical efficacy results through Month 3

In Cohort B (adults without moderate-to-severe immune compromise), most infection events occurred during a period of time when JN.1 and variants with similar susceptibilities were dominant. No deaths or COVID-19–related hospitalizations occurred in either treatment arm of Cohort B through Month 6.¹

PEMGARDA is not authorized for use in individuals who do not have moderate-to-severe immune compromise.¹

RT-PCR–confirmed symptomatic COVID-19, COVID-19–related
hospitalizations, or all-cause death^† through Month 3^1,‡

^†No COVID-19–related hospitalizations or deaths occurred in either treatment arm of Cohort B through Month 3.

^‡Following the initial dosing period of the trial.¹

Exploratory clinical efficacy results through Month 6

RT-PCR–confirmed symptomatic COVID-19, COVID-19–related
hospitalizations, or all-cause death^† through Month 6^1,§

^†No COVID-19–related hospitalizations or deaths occurred in either treatment arm of Cohort B through Month 6.

^§Cumulative through Month 6, following the initial dosing and redosing periods of the trial.¹

PEMGARDA is available

Be prepared to help prevent COVID-19 in your moderately to severely immunocompromised patients with PEMGARDA.

Order now