AstraZeneca’s Lynparza meets primary endpoint in Phase 3 prostate cancer trial
pharmafile | August 7, 2019 | News story | Research and Development | Lynpraza, PARP inhibitor, lynparza, pharma, prostate cancer
AstraZeneca’s PARP inhibitor Lynparza was successful in improving progression free survival in a Phase 3 trial of patients with metastatic prostate cancer.
The drug met its primary endpoint in the Phase 3 PROfound trial of men with metastatic castration-resistant prostate cancer (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).
Lynparza showed statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus standard of care treatments. The drug’s safety profile was generally consistent with previous clinical trials.
José Baselga, Executive Vice President, Oncology R&D, commented: “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, added: “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.”
Louis Goss
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