Overall Survival Data From POLO Trial: Ph III Study of Active Maintenance Olaparib vs Placebo for Germline BRCAMutated Metastatic Pancreatic Cancer

鈥� An ASCO Reading Room selection

June 13, 2023

Hedy L. Kindler, MD; Pascal Hammel, MD, PhD; Michele Reni, MD; Eric Van Cutsem, MD, PhD; Teresa Macarulla, MD, PhD; Michael J. Hall, MD; Joon Oh Park, MD, PhD; Daniel Hochhauser, MD, PhD; Dirk Arnold, MD, PhD; Do-Youn Oh, MD, PhD; Anke Reinacher-Schick, MD, PhD; Giampaolo Tortora, MD, PhD; Hana Alg眉l, MD, PhD, MPH; Eileen M. O'Reilly, MD; Sonal Bordia, MD; David McGuinness, MSc; Karen Cui, MD, PhD; Gershon Y. Locker, MD; and Talia Golan, MD

Journal of Clinical Oncology

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Purpose

The phase III POLO study demonstrated significant progression-free survival (PFS) benefit for active olaparib maintenance therapy versus placebo for patients with metastatic pancreatic adenocarcinoma and a germline BRCA mutation. Here, we report the final analysis of overall survival (OS) and other secondary end points.

Patients and Methods

Patients with a deleterious or suspected deleterious germline BRCA mutation whose disease had not progressed after ≥ 16 weeks of first-line platinum-based chemotherapy were randomly assigned 3:2 to active maintenance olaparib (300 mg twice daily) or placebo. The primary end point was PFS; secondary end points included OS, time to second disease progression or death, time to first and second subsequent cancer therapies or death, time to discontinuation of study treatment or death, and safety and tolerability.

Results

In total, 154 patients were randomly assigned (olaparib, n = 92; placebo, n = 62). No statistically significant OS benefit was observed (median 19.0 vs 19.2 months; hazard ratio [HR] 0.83, 95% CI 0.56-1.22, P=0.3487). Kaplan-Meier OS curves separated at approximately 24 months, and the estimated 3-year survival after random assignment was 33.9% versus 17.8%, respectively. Median time to first subsequent cancer therapy or death (HR 0.44, 95% CI 0.30-0.66, P<0.0001), time to second subsequent cancer therapy or death (HR 0.61, 95% CI 0.42-0.89, P=0.0111), and time to discontinuation of study treatment or death (HR 0.43, 95% CI 0.29-0.63, P<0.0001) significantly favored olaparib. The HR for second disease progression or death favored olaparib without reaching statistical significance (HR 0.66, 95% CI 0.43-1.02, P=0.0613). Olaparib was well tolerated with no new safety signals.

Conclusion

Although no statistically significant OS benefit was observed, the HR numerically favored olaparib, which also conferred clinically meaningful benefits including increased time off chemotherapy and long-term survival in a subset of patients.

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Overall Survival Data From POLO Trial: Ph III Study of Active Maintenance Olaparib vs Placebo for Germline BRCAMutated Metastatic Pancreatic Cancer

Primary Source

Journal of Clinical Oncology

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