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Tempus, GSK Initiate Phase II Trial of Niraparib in PALB2-Mutated Tumors

NEW YORK – Tempus and GlaxoSmithKline on Friday began a Phase II trial of GSK's PARP inhibitor niraparib (Zejula) in patients with advanced or metastatic PALB2-mutated solid tumors.

The single-arm trial, sponsored by Tempus, will enroll 110 patients with breast, colon, lung, pancreatic, esophageal, endometrial, head and neck, urologic, and skin cancers. The company will enroll patients with germline or somatic PALB2 mutations. The primary endpoint is overall response rate.

Tempus will use its TIME Trial program to support trial enrollment. Tempus will screen every patient sequenced through its platform for PALB2 somatic and germline mutations while the niraparib trial is ongoing.

According to the Chicago-based company, it also used its multi-modal dataset to complete protocol development and site selection in less than 60 days. "For this collaboration, our data-produced insights led to the design of a new trial that we can expedite through our robust diagnostic and just-in-time trial network," Kimberly Blackwell, Tempus' chief medical officer, said in a statement.

The findings from the trial will elucidate the pan-tumor activity of the PARP inhibitor when cancers harbor PALB2 mutations.

Niraparib is approved in the US for various ovarian cancer indications, including previously treated, advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have progressed more than six months after responding to platinum-based chemotherapy and are homologous recombination deficiency (HRD)-positive, which is defined as having a deleterious BRCA1/2 mutation or genomic instability.

AstraZeneca's PARP inhibitor olaparib (Lynparza) is also approved for different ovarian cancer indications, including in combination with bevacizumab (Genentech's Avastin) for the maintenance treatment of advanced, HRD-positive epithelial ovarian, fallopian tube, or primary peritoneal cancers in complete or partial response to first-line platinum-based chemo. Olaparib is approved in other biomarker-defined tumor types, too, including metastatic castration-resistant prostate cancer patients who have progressed following on enzalutamide or abiraterone, and who have deleterious germline or somatic mutations in various homologous recombination repair genes, including PALB2.