Phase III
Janssen will present data from the trial at a September conference in Stockholm. The company plans to seek FDA approval later this year.
A combination of Opdivo and Yervoy hit the primary endpoint in NSCLC patients with PD-L1 expression. Opdivo and chemotherapy did not demonstrate efficacy in patients regardless of PD-L1 expression.
With the positive results from this trial, as well as an earlier Phase III trial, Myovant Sciences plans to seek regulatory approval later this year.
In the trial, 396 patients with moderate-to-severe psychotic symptoms related to adult schizophrenia received either Nuplazid or placebo added to their current antipsychotic treatment. The patients receiving Nuplazid showed a consistent trend in symptom improvement but did not hit statistical significance on the primary endpoint.
At 96 weeks, 60% of the heavily pretreated HIV patients dosed with ViiV’s experimental treatment achieved virologic suppression.
While the trial did not hit its goals, Intec said data review has shown that certain subsets of patients saw a meaningful reduction in OFF time.
Takeda will release complete Phase III data at a future scientific conference and is planning on seeking regulatory approval for the investigational formulation.
Here’s a look at the top clinical trial news from last week, with updates from Neon, GSK, Biohaven, and more.
MyoKardia, Inc. announced updates related to its hypertrophic cardiomyopathy treatment portfolio, including lead therapeutic candidate, mavacamten.
In its third installment of the Good Pharma Scorecard, Roche and Novo Nordisk scored perfect marks in overall trial transparency, while Johnson & Johnson slipped from the high spot on the previous ranking.
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