Positive trial results for QUE Oncology's non-hormonal oral therapy

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QUE Oncology has announced that the results of its Phase 2 clinical trial of Q-122 have been published in The Lancet.

Q-122 is a novel non-hormonal oral therapy for the treatment of vasomotor symptoms, more commonly known as hot flushes and night sweats, in women taking endocrine therapy for breast cancer.

More than 75 per cent of breast cancers are hormone-sensitive, with endocrine therapy being the standard treatment option.

Endocrine therapy is recommended for five to ten years after cancer treatment for those women that had hormone-sensitive breast cancer, to prevent disease recurrence.

However, approximately 70 per cent of women taking endocrine therapy have vasomotor symptoms that contribute to over one-third of women prematurely stopping therapy.

The Phase 2 trial was a multicentre, randomised, double-blind, placebo-control trial involving 131 women taking endocrine therapy (tamoxifen or an aromatase inhibitor) following breast cancer.

The company said Q-122 therapy significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, with associated improvement in quality of life, compared with placebo.

Q-122 was also well tolerated with no serious adverse effects.

“Our research findings published in The Lancet demonstrate the efficacy of Q-122 as a non-hormonal oral treatment for vasomotor symptoms in women taking oral adjuvant endocrine therapy after breast cancer, with no evidence of treatment side effects,” said principal investigator and senior author, Professor Susan Davis Director, of the Monash University Women’s Health Research Program.

“In addition to a reduction in flushes and sweats, women who received Q-122 in the study reported a significantly lower likelihood of their hot flushes and sweats interfering with their sleep, and social and leisure activities, compared with placebo. If Q-122 can provide relief from these symptoms, it holds great potential for reducing discontinuation of endocrine therapy, enabling ongoing protection against breast cancer recurrence. This is an extremely important potential benefit of Q-122 beyond symptom relief alone,” added Professor Davis added.

QUE Oncology was formed through a joint venture between Emory University in Atlanta and the University of Queensland (UQ) research commercialisation company, UniQuest. The company has been supported by leading life science investors, including the Brandon Capital-managed Brandon BioCatalyst and Uniseed.

“It’s great to see extremely positive results from QUE Oncology’s Phase II trials published in the world's leading independent general medical journal. The research highlights the need for a therapy for patients undergoing endocrine therapy for breast cancer who are experiencing vasomotor symptoms, but also the broader potential for Q-122 beyond this patient group, including postmenopausal women, of which 70-80 per cent experience vasomotor symptoms,” said Dr Chris Nave, chairman of QUE Oncology and CEO of Brandon BioCatalyst.