- AstraZeneca's targeted cancer therapy Lynparza met the primary endpoint of a Phase 3 study testing the drug as a first-line maintenance treatment for a subset of pancreatic cancers, the U.K.-based pharma said Wednesday.
- Lynparza, which inhibits an enzyme called PARP, significantly outperformed placebo in the first-line maintenance of metastatic pancreatic cancer patients who express a germline BRCA mutation and whose disease hadn't progressed on platinum-based chemotherapy.
- Full data from the POLO trial will be presented at a future medical meeting, according to AstraZeneca.
Pancreatic cancer has been, and continues to be, one of the hardest tumor types to treat. A recent installment of the Annual Report to the Nation on the Status of Cancer found the five-year relative survival rate for the disease increased only about 6% from the periods of 1975-1977 to 2006-2012, from 2.5% to 8.5%. That increase was less than other cancers with low survival rates like liver, esophagus and stomach.
There's therefore a clear need for additional treatments beyond the 15 monotherapies the National Cancer Institute lists as approved by the Food and Drug Administration. AstraZeneca is looking to add Lynparza (olaparib) to the list as a first-line maintenance therapy.
A positive readout in POLO would help in that pursuit. The late-stage study enrolled 154 patients and gave them either 300 mg of Lynparza twice daily or placebo. While more data is needed to contextualize the magnitude of Lynparza's benefit in this setting, AstraZeneca leadership signaled confidence in the topline results issued Wednesday.
"The results of POLO provide further evidence of the clinical benefit of Lynparza across a variety of BRCA-mutated tumor types," José Baselga, head of oncology R&D at AstraZeneca, said in a Feb. 27 statement.
Of the four marketed PARP inhibitors, AstraZeneca's holds the most indications, including one it gained in December for first-line maintenance of advanced, BRCA-mutated epithelial ovarian, fallopian tube or primary peritoneal cancer that is in complete or partial response to first-line platinum-based chemotherapy.
Lynparza also leads in revenue compared to its main PARP competitors, Rubraca (rucaparib) from Clovis Oncology and Zejula (niraparib) from Tesaro, which is now owned by GlaxoSmithKline. Lynparza sales totaled $647 million in 2018, a 118% increase versus the year prior.
Securing an approval in another first-line maintenance setting could set up the drug for further growth.
What's more, the POLO data could have wider implications for pancreatic cancer treatment beyond just Lynparza's utility.
"The clinically-meaningful results of this trial potentially support the value of testing for germline BRCA mutations in patients with metastatic pancreatic cancer," Roy Baynes, chief medical officer at Merck Research Laboratories, said in the Feb. 27 statement.
Merck entered a global strategic oncology collaboration to co-develop and co-commercialize Lynparza in July 2017.