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Parkinson Agent Tavapadon Meets Primary and Secondary End Points as Monotherapy in Phase 3 TEMPO-1 Trial
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Results from the phase 3 TEMPO-2 trial, an additional study assessing tavapadon as a flexible-dose monotherapy, are expected by the end of this year.
Primal Kaur, MD, MBA
AbbVie has announced positive topline data from its phase 3 TEMPO-1 trial (NCT04201093) assessing its investigational agent tavapadon as a monotherapy for patients with Parkinson disease (PD). All told, the therapy met its primary end point, demonstrating a statistically significant improvement from baseline in Movement Disorder Society- Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.
TEMPO-1, a double-blind, placebo-controlled, parallel-group, randomized trial, tested the efficacy and safety of 2 fixed doses of tavapadon (5 mg; 15 mg) as a monotherapy in 529 enrolled adults with PD, aged 40-80 years old. In the study, results showed that patients treated in both groups experienced a statistically significant reduction from baseline compared with placebo (placebo: +1.8; 5 mg: –9.7; 15 mg: –10.2; P <.0001) in MDS-UPDRS Parts II and III at the end of the treatment period.
"The TEMPO-1 data, coupled with the previously reported TEMPO-3 adjunctive trial findings, further support the potential of tavapadon for people living with Parkinson disease,” Primal Kaur, MD, MBA, senior vice president of immunology, neuroscience, eye care, and special development at AbbVie, said in a statement.1 "This marks a significant step forward in our commitment to enhancing our neuroscience portfolio following the strategic acquisition of Cerevel Therapeutics and further demonstrates our dedication to supporting patients at all stages of this challenging neurological condition. We look forward to sharing additional data later this year from the TEMPO-2 monotherapy trial."
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Key secondary end points, which included change in MDS-UPDRS Parts II score and percentage of responders with “much improved” or “very much improved” on Patient Global Impression of Change, were also met with statistical significance. In addition, the safety profile of tavapadon, a selective D1/D5 receptor partial agonist, was consistent with prior clinical trials. AbbVie noted that the majority of adverse events (AEs) observed were mild to moderate in severity.
TEMPO-1 is part of a larger clinical development program that entails 4 trials assessing tavapadon in PD. TEMPO-2 (NCT04223193), another phase 3 study testing the effects of tavapadon as a monotherapy in a flexible-dose fashion, is expected to have data read out by the end of this year. In addition to the previously completed adjunctive TEMPO-3 trial (NCT04542499), the company is also conducting a fourth, open-label extension trial, dubbed TEMPO-4 (NCT04760769) that assesses the long-term safety and efficacy of the investigational agent.
In TEMPO-3, tavapadon met its primary end point of change in ON time without troublesome dyskinesia among treated patients with PD. When used as adjunctive to levodopa, patients on tavapadon experienced a clinically meaningful and statistically significant increase of 1.1 hours of total ON time without troublesome dyskinesia compared with those treated with levodopa and placebo (1.7 h vs 0.6 h; P <.0001). Although data was not provided, the company noted that the therapy demonstrated a statistically significant reduction in OFF time, the key secondary end point, in the tavapadon arm.2
TEMPO-3 included 507 adults with PD, aged 40-80 years old, who were randomly assigned to either tavapadon adjunctive to levodopa, titrated to 5-15 mg, or placebo and levodopa, orally and once-daily, for a 27-week treatment period. Those in the study entered experiencing motor fluctuations and were on a stable dose of levodopa for at least 4 weeks prior to screening. All told, tavapadon showed a safety profile that was consistent with previous observations, with a majority of the AEs being mild to moderate in severity.
