Positive results from two cohorts of the Targeted Agent and Profiling Utilization Registry (TAPUR) study provide real-world evidence to support recent clinical trial data that demonstrate a role for olaparib in the treatment of advanced prostate and pancreatic cancers with BRCA1/2-inactivating mutations. The findings were presented during the ASCO20 Virtual Scientific Program (Abstract 5567, Abstract 4637).
In two small cohorts, treatment with olaparib resulted in objective responses or stable disease for at least 16 weeks in more than two-thirds (68%) of patients with advanced prostate cancer and BRCA1/2-inactivating mutations, and nearly one-third (31%) of patients with advanced pancreatic cancer and BRCA1/2-inactivating mutations.
“TAPUR provides data from a broader population of patients than were included in pivotal trials of olaparib in these indications and supports its safety and effectiveness in patients with extensive prior treatment.”— Richard L. Schilsky, MD, FACP, FSCT, FASCO
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“It makes sense that a targeted therapy that works well and has been approved for one type of cancer with a particular mutation could also be effective for other types of cancer with the same mutation,” said Chief Medical Officer and Executive Vice President of ASCO, Richard L. Schilsky, MD, FACP, FSCT, FASCO. “TAPUR provides data from a broader population of patients than were included in pivotal trials of olaparib in these indications and supports its safety and effectiveness in patients with extensive prior treatment.”
Prostate Cancer Cohort
The first study included 29 patients with advanced prostate cancer with germline or somatic BRCA1/2-inactivating mutations. Patients had no remaining standard treatment options, measurable disease, adequate organ function, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. Twice daily, patients received olaparib as either 400-mg capsules or 300-mg tablets. Treatment continued until disease progression.
In the 25 patients evaluable for efficacy, 68% of patients had either an objective response (n = 9) or stable disease for at least 4 months (n = 8). Three patients had at least one grade 3 adverse or serious adverse event possibly related to olaparib. Reported events were consistent with the drug label.
These data support the recent FDA approval of olaparib for treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer.
Pancreatic Cancer Cohort
The second cohort included 30 patients with advanced pancreatic cancer and BRCA1/2-inactivating mutations previously treated with platinum-based therapy. These patients had no standard treatment options remaining, measurable disease, adequate organ function, and an ECOG performance status of 0–2. Twice daily, patients received either olaparib capsules or tablets until disease progression.
In the 26 patients evaluable for efficacy, 31% of patients had either an objective response (partial response in 1 patient) or stable disease for at least 4 months (7 patients). Four patients had at least one grade 3 adverse or serious adverse event possibly related to olaparib. Reported events were consistent with the drug label.
These findings support the recent FDA approval of olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma, and potentially extend its use to patients with more far advanced disease.
More on the TAPUR Study
The TAPUR Study is the first clinical trial conducted by ASCO. Focusing on patients with advanced cancers without remaining treatment options, TAPUR investigates whether specific targeted therapies can benefit patients based on specific genomic profiles of the tumors and lead to more personalized therapies.
TAPUR is a basket trial that groups tumors by specific genomic alterations regardless of the location in the body where the cancer originates. Today, the TAPUR Study has nearly 1,900 patients enrolled at more than 115 participating cancer centers, hospitals, and oncology practices in the United States. TAPUR has served as a model for similar studies around the world.
Disclosure: Funding for the TAPUR Study is provided by AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers-Squibb Company, Eli Lilly and Company, Genentech Inc., Merck & Co. Inc., and Pfizer Inc. For full disclosures of the study authors, visit coi.asco.org.
