San Francisco, CA (UroToday.com) — The Phase III PROfound trial of olaparib versus enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer (mCRPC) met the primary endpoint. The PROfound trial included men with mCRPC who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (e.g. enzalutamide and abiraterone).
Results from the trial showed a significant increase in the time patients selected for BRCA1/2 or ATM mutations live without radiographic disease progression vs. enzalutamide or abiraterone in men with mCRPC. The safety and tolerability profile of olaparib was generally consistent with previous trials.
José Baselga, Executive Vice President, Oncology R&D, said:
“For men with metastatic castration-resistant prostate cancer the disease remains deadly, especially in those who have failed on a new hormonal anticancer treatment. This trial is the only positive Phase III trial of any PARP inhibitor in metastatic castration-resistant prostate cancer, where the need for new, effective therapies is high. The PROfound trial also demonstrates the potential value of genomic testing in this at-risk patient population. We look forward to discussing these results with global health authorities soon.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said:
“Metastatic castration-resistant prostate cancer is a deadly disease and represents an area of critical unmet medical need. The Phase III PROfound trial is another example of MSD and AstraZeneca’s shared commitment to improving long-term outcomes for people living with cancer. These results represent the potential for a new, oral targeted treatment option for this patient population.”
AstraZeneca and MSD plan to present the full data from the trial at a forthcoming medical meeting. The companies are also exploring additional trials in prostate cancer, including the ongoing Phase III PROpel trial, testing
Lynparza as a 1st-line therapy in mCRPC, in combination with abiraterone.
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Lynparza Phase III PROfound trial in HRR* mutation-selected metastatic castration-resistant prostate cancer met primary endpoint. (2019). Retrieved 7 August 2019, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-phase-iii-profound-trial-in-hrr-mutation-selected-metastatic-castration-resistant-prostate-cancer-met-primary-endpoint-07082019.htmlhttps://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-phase-iii-profound-trial-in-hrr-mutation-selected-metastatic-castration-resistant-prostate-cancer-met-primary-endpoint-07082019.html