QUE Oncology's non-hormonal therapy reduces hot flushes and night sweats in women with breast cancer, published in The Lancet

MELBOURNE, Australia, Nov. 10, 2022 /PRNewswire/ -- QUE Oncology announces the results of its Phase II trial of Q-122, a novel non-hormonal oral therapy for the treatment of vasomotor symptoms (commonly known as hot flashes/flushes and night sweats) in women taking endocrine therapy for breast cancer, have been published in The Lancet.  

More than 75 per cent of breast cancers are hormone-sensitive, with endocrine therapy being the standard treatment option^[1]. Endocrine therapy is recommended for 5-10 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 this important therapy.

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

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 well tolerated with no serious adverse effects. These results demonstrate the promise of Q-122 as a novel and differentiated, non-hormonal treatment of vasomotor symptoms for women with breast cancer taking endocrine therapy, and the potential for its use in post-menopausal women experiencing similar symptoms.

"Our research findings published in The Lancet demonstrate 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," explains 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," 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," says Dr Chris Nave, Chairman of QUE Oncology and CEO of Brandon BioCatalyst.

The results of QUE Oncology's Phase II study support the conduct of larger and longer studies of Q-122, with potential use extending to postmenopausal women who require an alternative to oestrogen therapy for vasomotor symptoms.

^[1] Bell RJ, Fradkin P, Schwarz M, Davis SR. Understanding discontinuation of oral adjuvant endocrine therapy by women with hormone receptor positive invasive breast cancer nearly 4 years from diagnosis.  Menopause. 2013 Jan;20(1):15-21

ENDS

Q-122 Phase 2 study:

Eligible participants were women, aged 18–70 years, taking a stable dose of tamoxifen or an aromatase inhibitor following breast cancer and experiencing at least 50 self-reported moderate to severe vasomotor symptoms per week.

Participants were randomly assigned (1:1) using an interactive web response system to oral Q-122 100 mg or identical placebo, twice daily for 28 days. Randomisation was stratified by BMI (≤30 kg/m² or >30 kg/m²) and use of any of a selective serotonin reuptake inhibitor, selective norepinephrine reuptake inhibitor, gabapentin, or pregabalin.

Between Oct 24, 2018, and Sept 9, 2020, 243 patients were screened, 131 of whom were randomly assigned and received treatment (Q-122 n=65 and placebo n=66).

• Q-122 resulted in a significantly greater mean percentage change in msVMS-SS from baseline over 28 days of treatment compared with placebo (least squares mean: Q-122, –39% [95% CI –46 to –31] vs placebo –26% [–33 to –18]; p=0・018).
• Treatment-emergent adverse events were generally mild to moderate and similar between the two groups (treatment-related treatment-emergent adverse events in 11 [17%] of 65 patients in the Q-122 group vs nine [14%] of 66 in the placebo group); zero patients in the Q-122 group and two (3%) patients in the placebo group had serious adverse events.

About QUE Oncology

QUE Oncology is a clinical stage company developing drugs for unmet medical needs. The lead program, Q-122 is in development as a novel non-hormonal treatment for moderate to severe vasomotor symptoms (hot flashes and night sweats) in postmenopausal women, and in cancer patients receiving hormone therapy. The clinical results of Q-122, as an effective and well tolerated non-hormonal oral treatment for vasomotor symptoms, warrant its further development in larger and longer studies.

QUE Oncology was formed through a joint venture between Emory University in Atlanta and the University of Queensland research commercialization company, UniQuest. QUE Oncology is backed by venture capital groups, led by Brandon Capital-managed Brandon BioCatalyst and Uniseed.

https://www.queoncology.com/about-que

About Q-122

Q-122 is an orally bioavailable, non-hormonal, small molecule that is being developed as a treatment for vasomotor symptoms in postmenopausal women, and in cancer patients receiving hormone therapy. Promising clinical activity and an excellent safety profile of Q-122 has been demonstrated in early clinical trials of healthy volunteers, cancer patients, and breast cancer survivors taking endocrine therapy who were experiencing vasomotor symptoms (over 125 total subjects). Functionally in preclinical studies, Q-122 exhibits a novel mechanism of action, which is not an NK3 receptor antagonist.