AstraZeneca reveals more positive data from Lynparza trials
AstraZeneca and its partner MSD announced positive results from the phase 3 ‘PROfound’ trial of Lynparza (olaparib) on Wednesday, in men with metastatic castration-resistant prostate cancer (mCRPC), who had a homologous recombination repair gene mutation (HRRm) and had progressed on prior treatment with new hormonal anticancer treatments.
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The FTSE 100 pharmaceuticals giant said results from the trial showed a “statistically significant and clinically meaningful” improvement in the primary endpoint of radiographic progression-free survival (rPFS) with Lynparza, compared to enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations - a subpopulation of HRR gene mutations.
It said the safety and tolerability profile of Lynparza was generally consistent with previous trials.
“For men with metastatic castration-resistant prostate cancer the disease remains deadly, especially in those who have failed on a new hormonal anticancer treatment,” said José Baselga, AstraZeneca’s executive vice-president of oncology research and development.
“This trial is the only positive phase 3 trial of any PARP inhibitor in metastatic castration-resistant prostate cancer, where the need for new, effective therapies is high.”
Baselga said the PROfound trial also demonstrated the potential value of genomic testing in such an 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, and chief medical officer at MSD Research Laboratories, added that metastatic castration-resistant prostate cancer was a deadly disease, which represented an area of critical unmet medical need.
“The phase 3 PROfound trial is another example of MSD and AstraZeneca's shared commitment to improving long-term outcomes for people living with cancer,” Baynes explained.
“These results represent the potential for a new, oral targeted treatment option for this patient population.”
AstraZeneca and MSD said they planned to present the full data from the trial at a forthcoming medical meeting.
The companies said they were also exploring additional trials in prostate cancer, including the ongoing phase 3 ‘PROpel’ trial, testing Lynparza as a first-line therapy in mCRPC, in combination with abiraterone.