Niraparib promoted long-term progression-free survival benefit in Phase 3 advanced ovarian cancer study 

Brentford, UK–headquartered GSK (LSE/NYSE:GSK) reported long-term data from the phase 3 PRIMA study indicating that the PARP inhibitor Zejula (niraparib) promoted a sustained and clinically meaningful progression-free survival (PFS) benefit in ovarian cancer patients.

The survival benefit was evident across biomarker subgroups, including BRCAm, HRd and HRp.

Patients in the HRd subgroup had a 48% reduction of progression or death compared to placebo.

The estimated probability of no progressive disease or death at four years in the broader population was 24% for niraparib compared to 14% for placebo.

GSK plans to present the updated efficacy analysis data on September 11 at the (European Society for Medical Oncology) ESMO Annual Meeting in Paris.

GSK noted in a news release that the overall survival data are “not yet mature based on the prespecified analysis plan.”

The study tested niraparib as maintenance therapy in first-line ovarian…

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Ivy Brain Tumor Center partners with GSK and UCSF to test Zejula in brain cancer patients

The Ivy Brain Tumor Center (Phoenix) and University of California, San Francisco will partner on a Phase 0 clinical trial to test GSK’s (NYSE:GSK) Zejula (niraparib) in patients with newly diagnosed glioblastoma (GBM) and recurrent glioma (grades II–IV).

Zejula is a daily oral poly (ADP-ribose) polymerase (PARP) inhibitor.

FDA introduced Phase 0 clinical trials in 2004 to close the gap between initial drug testing and later-phase efficacy studies. If a drug shows promise in a Phase 0 trial, investigators can fast-track it to a Phase 2 study.

“Our mission is to do things differently from what has been done before,” said Shwetal Mehta, chief operating officer of the Ivy Brain Tumor Center, in an interview.

Many drugs tested for brain cancer have trouble crossing the blood-brain barrier, and yet conventional trials don’t tend to be nimble enough to measure near-term efficacy.

“We want to identify drugs that are effective, and we want to do thi…

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