Clarity on 401 results1 Nov 2018 09:27
Patients were classified into responders and non-responders as a result of obvious
visual clustering in survival times. Of those patients who had more than 10 days of
VAL401 treatment, 60% fell into the responders’ group, providing an overall
response rate of 60%. From this small patient population, data suggest that
responder patients obtain an increase in mean PFS and in mean OS of 8.7 weeks
and 12.9 weeks, respectively, compared with the non-responder population, at 4.3
weeks and 7.1 weeks, respectively. The difference and rationale between
responders and non-responders to VAL401 is not clear yet, and will be investigated
in future trials.
In addition, biochemical analyses on two responders suggest that VAL401 did not
reduce the number of white blood cells and, therefore, does not cause the immune
suppression usually seen with traditional therapies. Hence, there is potential for
VAL401 to be taken in combination with other chemotherapy or immunotherapy drugs.
The side effects recorded were expected as they included effects attributed to the
underlying disease of the patients, and were also expected for risperidone use.
Quality of life data
With VAL401, the initial aim of ValiSeek is to extend the life expectation of the
late-stage lung cancer patients and, also another important factor for this late-stage
type of population, to improve their quality of life. A questionnaire consisting of over
30 questions was completed by the patients and revealed various aspects of their
quality of life. Nineteen specific factors were seen to have improved after treatment,
with general improvement in quality of life – for responders and non-responders,
including:
► improvement in pain (4);
► improvement in insomnia (2);
► improvement in appetite (2);
► improvement in depression (2);
► improvement in irritability (1);
► improvement in fatigue (3) and ability to take part in leisure activities (2);
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