Tempus announced the commencement of an open label phase II study, in collaboration with GlaxoSmithKline (GSK) to evaluate the efficacy and safety of ZEJULA (niraparib), a poly (ADP-ribose) polymerase (PARP) inhibitor used for patients with advanced or metastatic solid tumors and a germline or somatic PALB2 mutation. The study, titled “Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors” (the PAVO study, NCT05169437) is sponsored by Tempus and opened for enrollment on January 7, 2022. Patients with PALB2 mutations have been shown to be at an increased risk of being diagnosed with breast and pancreatic cancers.

Recent studies demonstrate that patients with metastatic breast and pancreatic cancers with germline PALB2 mutations have benefited from treatment with PARP inhibitors. ZEJULA is an oral, once-daily PARP inhibitor approved by the FDA in 2017 for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. Phase 3 clinical trials are underway to evaluate the efficacy and safety of niraparib alone or in combination in additional solid tumors, including breast and lung cancers.

The PAVO study applies an innovative, data-driven approach designed to accelerate and streamline study timelines, and the signal-seeking process for niraparib. Additionally, Tempus leveraged its multi-modal dataset to expedite the protocol development and intelligent site selection in under 60 days. The PAVO study is designed to enroll solid tumor patients with germline or somatic PALB2 mutations.

Tempus is leveraging its TIME Trial Program, a just-in-time network of providers, to support rapid patient identification, site activation, and clinical trial enrollment. Under the study protocol, every patient sequenced through Tempus' genomic sequencing platform will be pre-screened for PALB2 somatic and germline mutations.