Veru and Eli Lilly have signed a clinical trial partnership and supply agreement to analyse enobosarm plus Verzenio (abemaciclib) in Phase III ENABLAR-2 clinical trial to treat AR+ER+HER2- metastatic breast cancer.
An oral, new chemical entity and selective androgen receptor (AR) of Veru, enobosarm acts on the agonist that stimulates the AR, a suppressor of the tumour.
Lilly’s Verzenio is a non-chemotherapy oral tablet and an inhibitor of cyclin-dependent kinase 4/6 (CDK4/6).
As per the deal, Veru will carry out the study while Lilly will be in charge of the Verzenio supply needed for the trial.
Furthermore, Veru holds complete exclusive, worldwide rights to enobosarm.
Through the partnership, the companies will assess the safety and efficacy of 9mg oral doses of enobosarm given daily plus Verzenio versus active control in second-line treatment of AR+ ER+ HER2- metastatic breast cancer.
The multicentre, open-label, randomised, active control trial will enrol 186 individuals with metastatic AR+ ER+ HER2- breast cancer, who had earlier been given an estrogen-blocking agent plus palbociclib.
Anticipated to start during the first quarter of this year, the trial will be carried out in nearly 35 trial centres in the US.
Median radiographic progression-free survival will be the primary efficacy endpoint of the trial.
Overall response rate, variation in short physical performance battery and change in DEXA-body composition muscle and bone will be included as the secondary endpoints.
Veru chairman, president and CEO Mitchell Steiner said: “Independently conducted proof of concept preclinical studies in human breast cancer models have demonstrated that the combination of enobosarm with a CDK4/6 inhibitor had greater antitumor synergistic activity in tumour samples from patients who had breast cancer progression following treatment with palbociclib, a CDK4/6 inhibitor, and an estrogen-blocking agent.”
In March last year, Lilly reported positive patient-reported outcomes from a trial that analysed the efficacy of Verzenio to treat high-risk early breast cancer.