Lynparza (olaparib), has met the primary endpoint in a Phase III prostate cancer trial.
The primary endpoint was significantly increasing the time patients selected for BRCA1/2 or ATM mutations live without radiographic disease progression vs. standard of care treatment, which the drug achieved in men with metastatic castration-resistant prostate cancer (mCRPC). Specifically, those 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).
The results showed a statistically-significant and clinically-meaningful improvement in radiographic progression-free survival (rPFS) with Lynparza, meaning that the treatment is now the only PARP inhibitor with positive Phase III results in four different cancer types – ovarian, breast, pancreatic and prostate.
NCCN, Prostate Cancer 2019
Joaquin Mateo, M.D., Suzanne Carreira, Ph.D., Shahneen Sandhu, M.D., Susana Miranda, B.Sc., Helen Mossop, M.Math.Stat., Raquel Perez-Lopez, M.D., Daniel Nava Rodrigues, M.D., Dan Robinson, Ph.D., Aurelius Omlin, M.D., Nina Tunariu, M.D.Res., Gunther Boysen, Ph.D., Nuria Porta, Ph.D., Penny Flohr, B.Sc., Alexa Gillman, B.Sc., Ines Figueiredo, B.Sc., Claire Paulding, B.Sc., George Seed, M.Sc., Suneil Jain, M.D., Christy Ralph, M.D., Andrew Protheroe, M.D., Ph.D., Syed Hussain, M.D., Robert Jones, M.D., Ph.D., Tony Elliott, M.D., Ph.D., Ursula McGovern, M.D., Ph.D., Diletta Bianchini, M.D., Jane Goodall, B.Sc., Zafeiris Zafeiriou, M.D., Chris T. Williamson, Ph.D., Roberta Ferraldeschi, M.D., Ph.D., Ruth Riisnaes, F.I.B.M.S., Bernardette Ebbs, B.T.E.C., Gemma Fowler, B.Sc., Desamparados Roda, M.D., Wei Yuan, Ph.D., Yi-Mi Wu, Ph.D., Xuhong Cao, M.S., Rachel Brough, Ph.D., Helen Pemberton, Ph.D., Roger A’Hern, Ph.D., Amanda Swain, Ph.D., Lakshmi P. Kunju, M.D., Rosalind Eeles, M.D., Ph.D., Gerhardt Attard, M.D., Ph.D., Christopher J. Lord, Ph.D., Alan Ashworth, Ph.D., Mark A. Rubin, M.D., Karen E. Knudsen, Ph.D., Felix Y. Feng, M.D., Ph.D., Arul M. Chinnaiyan, M.D., Ph.D., Emma Hall, Ph.D., and Johann S. de Bono, M.B., Ch.B., Ph.D., DNA-Repair Defects and Olaparib in Metastatic Prostate Cancer. N Engl J Med 2015; 373:1697-1708October 29, 2015
Lynparza, Prescribing Information 2018
Michael Choi, Thomas Kipps and Razelle Kurzrock, ATM Mutations in Cancer: Therapeutic Implications. Molecular Cacner Therapeutics August 2016
Volume 15, Issue 8
Joaquin Mateo, M.D., Suzanne Carreira, Ph.D., Shahneen Sandhu, M.D., Susana Miranda, B.Sc., Helen Mossop, M.Math.Stat., Raquel Perez-Lopez, M.D., Daniel Nava Rodrigues, M.D., Dan Robinson, Ph.D., Aurelius Omlin, M.D., Nina Tunariu, M.D.Res., Gunther Boysen, Ph.D., Nuria Porta, Ph.D., et al. DNA-Repair Defects and Olaparib in Metastatic Prostate Cancer. N Engl J Med 2015; 373:1697-1708