GSK/Tesaro PARP inhibitor Zejula wins another speedy review
Months after partner Zai Lab $ZLAB scored an accelerated review for PARP therapy Zejula in China, GSK has secured priority US review for the drug, known chemically as niraparib, to expand the use of the drug in patients with advanced ovarian cancer.
The drug was submitted for review in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer patients with or without BRCA mutations who have been treated with three or more prior chemotherapy regimens based on data from the QUADRA trial, which showed 13 (28%) of 47 patients in the primary efficacy population achieved an overall response — the best response recorded from the start of the treatment until the disease progresses — as per RECIST (Response Evaluation Criteria in Solid Tumors) methodology.
“The results of the QUADRA study demonstrate that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations,” said Tesaro’s COO Mary Lynne Hedley in a statement.
Ovarian cancer is the most common cause of gynaecological cancer death in the United States. Although most patients with advanced ovarian cancer respond to initial therapy, 70% will relapse and ultimately succumb to their disease. Late-line treatment options for patients with ovarian cancer are few, with the proportion of patients achieving an overall response typically less than 10%, and median overall survival after third-line therapy of 5–9 months, researchers noted in Lancet Oncology.
The drug, which competes against AstraZeneca’s $AZN Lynparza as well as Clovis’ $CLVS Rubraca, is already approved as a firstline maintenance treatment of women with recurrent ovarian, fallopian tube, or primary peritoneal cancer when their cancer comes back.
The once-daily Zejula is currently being evaluated in three pivotal trials, including a late-stage trial in patients with first-line ovarian cancer (the PRIMA trial), a Phase III trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a registrational Phase II treatment trial in patients with ovarian cancer (the QUADRA trial). Partner J&J $JNJ is testing the use of the drug in prostate cancer. Meanwhile, a number of combination trials are also underway, including testing the use of Zejula and Merck’s $MRK keystone checkpoint inhibitor Keytruda in breast and ovarian cancer.