Phase 3 clinical success of AstraZeneca/Mersk’s PARP inhibitor Lynparza

Compilenewborn

On September 24, AstraZeneca and Merck announced the interim analysis results from the Phase 3 PROpel trial
.

Data show that in the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC), regardless of whether it carries homologous recombination repair (HRR) gene mutations, compared with Zytiga (abiraterone, abiraterone), Lynparza (olaparib, olaparib) Pani) and Zytiga combined treatment showed statistically significant and clinically significant improvements in the primary endpoint of radiographic progression-free survival (rPFS), and there is also a trend of improvement in the key secondary endpoint of overall survival (OS), but At the time of the interim analysis, the OS data was not yet mature

Lynparza is a PARP inhibitor that was approved by the US FDA in May 2020 for the treatment of mCRPC patients who have undergone a new type of hormone therapy Zytiga or Xtandi (enzalutamide, enzalutamide) and who have a mutation in the HRR gene
.

HRR gene mutations account for about 20-30% of mCRPC

It is worth mentioning that Lynparza is the first PARP inhibitor to show clinical benefit in the first-line treatment of prostate cancer
.

The high level of positive results from the PROpel test is expected to open up a broader market for Lynparza

The first-line treatment options for mCRPC are limited, and many patients will progress to the disease after receiving the current standard care regimen
.

The combination of Lynparza and Zytiga has the potential to provide a new first-line treatment option for mCRPC patients regardless of their biomarker status

At present, the competition of PARP inhibitors in the first-line treatment of prostate cancer is intensifying
.

Johnson & Johnson is also evaluating the PARP inhibitor Tesaro, Zytiga, and prednisone in the first-line treatment of mCRPC patients in the Phase 3 Magnite trial, including patients with or without HRR pathway genetic changes

In May last year, the US FDA also approved Clovis's PARP inhibitor Rubraca as a third-line treatment for BRCA mutation-positive mCRPC
.

BRCA mutation is a type of HRR pathway defect

Pfizer is also evaluating Talzenna in combination with Xtandi as the first-line treatment of prostate cancer in the Phase 3 TALAPRO-2 trial
.

Talzenna is also a PARP inhibitor, only approved to treat BRCA mutant breast cancer

At present, Lynparza is in a leading position in the field of PARP inhibitors, with sales of US$1.
13 billion in the first half of 2021, a year-on-year increase of 15%
.

With the victory of the latest first-line treatment of mCRPC and the recent positive data of adjuvant treatment of high-risk early breast cancer, Lynparza is expected to grow further in the future

Reference source:

Lilly, Novartis, other pharmas could face fines for violating 340B law