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AstraZeneca/Merck's PARP inhibitor Lynparza (olaparib, olaparib) may have a better label than rival GlaxoSmithKline/Johnson & Johnson's PARP inhibitor Zejula (niraparib, niraparib) for ovarian cancer narrow, but when it comes to prostate cancer, the situation may be reversed
.
PROpel in newly diagnosed metastatic castration resistance with or without homologous recombination repair (HRR) mutations In men with prostate cancer (mCRPC), Lynparza + Zytiga + steroids reduced the risk of disease progression or death by 34% compared to standard-of-care therapy Zytiga (abiraterone acetate) + steroids (HR=0.
66, p<0.
0001)
.
Median radiographic progression-free survival (rPFS) was 24.
PARP inhibitors, such as Lynparza and Zejula, have historically worked best in cancers with HRR mutations
.
A prespecified subgroup analysis based on HRR biomarker status showed: (1) Among patients with HRR mutations, the Lynparza group had a 50% lower risk of disease progression or death compared with the control group (HR=0.
About a quarter of the patients in this study had HRR genetic alterations, which roughly reflects the true makeup of HRR mutations in about 20-30% of all mCRPC patients
.
Although the rPFS benefit of Lynparza in the entire patient population declined to 34%, dragged down by non-HRR-mutated cases, this still appears to be better than the 27% benefit Zejula showed in patients with HRR alterations in its own Phase 3 clinical trial , also in combination with Zytiga and steroids in the latter Phase 3 trial
.
It is worth noting, however, that there are important differences between the 2 trials
.
A major difference is that Lynparza's Phase 3 PROpel trial used investigators' assessments of progression-free survival, while Zejula's Phase 3 Magnitude trial used blinded central review assessments
Lynparza also showed a trend towards extending overall survival (OS) in all patients
.
But so far, the OS data maturity at the interim analysis is only 29%, and the difference has not yet reached statistical significance
Zejula was developed by Tesaro, which GSK acquired in December 2018 for $5.
1 billion
.
Under the agreement signed in April 2016, Johnson & Johnson has the exclusive rights to Zejula to treat prostate cancer
Nonetheless, Lynparza maintained its market leadership with sales of $2.
75 billion in 2021, a 21% increase from last year, driven in part by its additional sales in breast, pancreatic, and previously treated mCRPC.
Indications, all of which are limited to BRCA or HRR mutations
.
By comparison, Zejula's sales were just £395 million ($534 million), up 22% from 2020
With US FDA approval in second-line mCRPC in 2020, Lynparza became the first molecularly-driven therapy in the disease to require biomarker detection
.
So far, AstraZeneca has successfully increased the U.
Now, Lynparza is expected to gain another strong foothold in prostate cancer for the treatment of a wider population
.
In prostate cancer, Johnson & Johnson's Zejula may be limited to the HRR mutation field, and the drug will have to fight an uphill battle with Lynparza to gain market share
Reference article:
1.
ASCO GU: AstraZeneca, Merck's Lynparza one-ups J&J's Zejula with prostate cancer win regardless of gene mutations
2.
ASCO GU: J&J plays up precision therapy approach for Zejula's prostate cancer bid after mixed results
