In October 2015, the global phase II clinical trial results of Validive were announced, demonstrating initial evidence of clinical activity and safety compared to placebo. The trial enrolled 183 patients and was conducted in more than thirty centers in Europe and in the U.S. This global, multi-center, double-blind, randomized, placebo-controlled, three-arm study (NCT01385748) compared the efficacy and safety of Validive (50 microgram (µg) and 100 µg) to placebo in patients with surgically resected HNC receiving chemoradiation therapy. Validive and placebo were applied to the gum once daily 1-3 days prior to chemoradiotherapy until the end of chemoradiotherapy treatment.
The safety profile of Validive was very good, with a similar number of adverse events between the placebo and Validive (100 μg) cohorts. However, patients treated with Validive experienced less nausea and dysphagia compared to placebo.
|Placebo (N=62)||Validive® 50 μg (N=56)||Validive® 100 μg (N=65)||Validive® pooled doses (N=121)|
|Patients experienced at least one TEAE||61 ( 98.4%)||48 ( 87.3%)||60 ( 93.8%)||108 ( 90.8%)|
|Patients experienced at least one TEAE related to the study treatment||18 ( 29.0%)||14 ( 25.5%)||18 ( 28.1%)||32 ( 26.9%)|
|Patients experienced at least one severe TEAE (≥ grade 3) related to study treatment||4 ( 6.5%)||8 ( 14.5%)||4 ( 6.3%)||12 ( 10.1%)|
|Patients permanently removed from the study due to a TEAE||1 ( 1.6%)||3 ( 5.5%)||3 ( 4.7%)||6 ( 5.0%)|
Compliance and acceptability of the treatment found the average overall patient compliance to be 95%, with a median of 98%. Overall compliance according to patient diaries was similar in all treatment groups and consistent with the compliance according to the investigator’s evaluation
The analysis of OPC patients in this study showed:
The effect of Validive on SOM was much greater in OPC compared to non-OPC patients in this phase II trial. The results of this trial support the further development of Validive for the treatment of SOM in patients with OPC.
Adaptive trial that will evaluate Validive