GSK’s Zejula sees boost in BAP1-mutated and DDR-deficient tumours
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LoA Update: GSK’s Zejula sees boost in chances to transition to next development stage in BAP1-mutated and DDR-deficient tumours

By William Newton 11 Jun 2021

GlaxoSmithKline’s Zejula (niraparib) Phase Transition Success Rate (PTSR) score rose in several solid tumours on 7 June, after a Phase II trial that was previously suspended for an interim analysis, started recruiting as per a 3 June ClinicalTrials.gov update.

LoA Update: GSK’s Zejula sees boost in chances to transition to next development stage in BAP1-mutated and DDR-deficient tumours
The study is focused on Zejula’s activity in tumours with mutations in BAP1 and specific DNA damage response (DDR) pathway genes. Credits: David A Litman/Shutterstock.com.

GlaxoSmithKline’s Zejula (niraparib) Phase Transition Success Rate (PTSR) score rose in several solid tumours on 7 June, after a Phase II trial that was previously suspended for an interim analysis, started recruiting as per a 3 June ClinicalTrials.gov update. The study is focused on Zejula’s activity in tumours with mutations in BAP1 and specific DNA damage response (DDR) pathway genes.

The PARP inhibitor’s PTSR score increased by 20, 13, 11 and six points in cholangiocarcinoma, uveal melanoma, renal cell carcinoma, and malignant mesothelioma, respectively. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. Following the trial status update, the PTSRs in the aforementioned indications increased to 36%, 27%, 36%, and 37% respectively, as of 7 June. The 46-patient Phase II Zejula study is using objective response rate (ORR) at one year as its primary endpoint, and has an expected primary completion date in December 2021, according to ClinicalTrials.gov.

The PTSR score calculated for a drug takes into consideration characteristics like therapy area, indication and molecule type. A Likelihood of Approval score (LoA) is calculated by compounding the PTSR at each stage the drug is yet to progress through. The LoAs for Zejula stand at 11%, 2%, 15% and 12% in cholangiocarcinoma, uveal melanoma, renal cell carcinoma, and malignant mesothelioma, respectively. Zejula is currently marketed as a treatment in different settings for ovarian cancer, fallopian tube cancer, and peritoneal tumours. GlaxoSmithKline has a market cap of $98.26bn.

William Newton is a Healthcare Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.