Long-term Tezepelumab Safety, Efficacy Data Consistent With Earlier Trials

The long-term safety and efficacy profile of tezepelumab in the DESTINATION phase 3 extension trial was consistent with data from the previous PATHWAY phase 2 and NAVIGATOR phase 3 trials, according to an AstraZeneca press release.

DESTINATION, a randomized, double-blind, placebo-controlled, long-term extension trial, included patients 12 years and older with severe, uncontrolled asthma. All patients included in DESTINATION completed the 52-week NAVIGATOR or 48-week SOURCE studies comparing tezepelumab plus standard of care with placebo plus standard of care. The patients received treatment with medium- or high-dose inhaled corticosteroids plus at least 1 additional controller medication with or without oral corticosteroids.

The primary objective of the DESTINATION trial was to evaluate the long-term safety and tolerability of tezepelumab over a 104-week period, including the treatment period of either NAVIGATOR or SOURCE predecessor studies. The secondary end point was to evaluate the treatment’s long-term impact on asthma exacerbations.

In patients from the NAVIGATOR study, there was an annualized asthma exacerbation rate reduction of 58% (95% CI, 49-65) in patients treated with tezepelumab plus standard of care over 104 weeks, while the SOURCE study showed an annualized asthma exacerbation reduction of 39% (95% CI, 4-62).

The adverse event rates in both studies were lower in patients treated with tezepelumab plus standard of care than in patients treated with placebo plus standard of care.

In patients from the NAVIGATOR study, the safety and efficacy data showed the incidence rate of adverse events per 100 patient years was 49.62 in patients who received tezepelumab and 62.66 in patients who received placebo. The serious adverse event rate was 7.85 in patients treated with tezepelumab and 12.45 in patients treated with placebo.

In the SOURCE study, the incidence rate of adverse events per 100 patient years was 47.15 in patients who received tezepelumab and 69.97 in patients who received placebo. The incidence rate of serious adverse events per 100 patient years was 13.14 in patients treated with tezepelumab and 17.99 in patients treated with placebo.

“The results from DESTINATION confirm that the overall long-term efficacy and safety profile for Tezspire is consistent with the previously reported PATHWAY and NAVIGATOR trials and sustained over 2 years,” Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said in a press release.