AstraZeneca underwent a restructuring earlier this year with an increased focus on oncology.
Roland Magnusson / Shutterstock
AstraZeneca is here to stay as a leader in oncology treatments.
That was the sentiment Olivier Nataf, head of AstraZeneca’s U.S. oncology business unit, shared with BioSpace ahead of the annual American Society of Clinical Oncology meeting in Chicago. Nataf touted the strong data the company shared at the meeting, particularly with its PARP inhibitory, Lynparza. The drug showed robust data in the treatment of patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas. AstraZeneca, and its co-developer Merck, will use data from the Phase III POLO trial to seek approval of Lynparza in this indication. The companies noted that Lynparza reduced the risk of disease progression by 47% compared to placebo. The median PFS for patients treated with Lynparza was 7.4 months, compared to 3.8 months for those on placebo. The companies said there were more than twice as many patients remaining progression free at both one year, 34% to 15% and two years, 22% vs. 10%, respectively.
Lynparza did not just wow in the treatment of pancreatic cancer, though. Lynparza also posted strong results in ovarian cancer as well. In December, Lynparza won approval from the U.S. Food and Drug Administration for use as a first-line maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy. At ASCO, AstraZeneca followed on that approval with data from its Phase III SOLO3 study in germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer. Nataf said the SOLO3 study is particularly interesting as the company has aimed its vaunted PARP inhibitor further down the treatment line.
Results from the SOLO-3 trial showed BRCAm advanced ovarian cancer patients treated with Lynparza demonstrated a statistically significant and clinically meaningful improvement in ORR and PFS compared to chemotherapy. The data highlights Lynparza’s clinical benefit regardless of line of treatment for women with BRCAm advanced ovarian cancer and the importance of knowing BRCA status at diagnosis. The trial was conducted as a post-approval commitment in agreement with the FDA.
“This is really an interesting study because it’s for patients who cannot use platinum treatment anymore. What’s interesting, is it’s Lynparza monotherapy versus chemotherapy. In overall response rate and PFS (progression-free survival) you will see a benefit against chemotherapy,” Nataf told BioSpace.
Nataf said the results from the SOLO-3 trial, as well as the SOLO-1 trial that won Lynparza approval in December, demonstrate the efficacy of the PARP inhibitor in patients with gBRCAm advanced ovarian cancer.
“Lynparza is a very attractive therapy for patients,” Nataf said.
In addition to Lynparza, AstraZeneca also touted results from the Phase III PACIFIC trial for Imfinzi (durvalumab) in unresectable, Stage III non-small cell lung cancer (NSCLC) over the weekend. A presentation of a post-hoc analysis of the trial showed longer OS evidence in patients with this particular kind of cancer, the only immunotherapy to demonstrate this kind of survivability for this cancer, the company said. The OS rate was 57% at three years for patients receiving Imfinzi vs. 43.5% for placebo following concurrent chemoradiation therapy (CRT). Median OS was not yet reached with the Imfinzi arm versus 29.1 months for placebo. The post-hoc analysis provided an additional year of follow-up data that showed Imfinzi provided consistent efficacy, maintaining a 31% reduction in the risk of death vs. placebo after CRT. Nataf s summed up the results in a short statement, “sustainable, overall survival.”
AstraZeneca underwent a restructuring earlier this year with an increased focus on oncology. The U.K. pharma giant brought in former Memorial Sloan Kettering Cancer Center Chief Medical Officer José Baselga as its new head of oncology research and discovery. Since Baselga joined the company, Nataf said AstraZeneca’s oncology team has been invigorated. The company has become a different company with a focus on oncology. Nataf said Baselga is a leader in cancer research with “a lot of incredible and innovative ideas.”
“He has brought a lot of passion and is now leading an R&D organization form early-stage to late stage. It is solely focused on oncology,” Nataf said. “AstraZeneca in oncology is here to stay.”
