EFFICACY

First-line maintenance therapy for patients with gBRCA-mutated* metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy1

In the POLO trial, LYNPARZA nearly doubled median PFS (7.4 months vs 3.8 months with placebo)1

STUDY DESIGN

POLO: A pivotal phase 3 trial1-3

The POLO trial was a multicenter, double-blind, randomized, placebo-controlled, phase 3 trial of LYNPARZA maintenance therapy in patients with gBRCA-mutated metastatic pancreatic cancer.

Patients Icon

Patients tested for gBRCAm

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Chemotherapy Icon

Patients received first-line platinum-based chemotherapy

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LYNPARZA and Placebo Dosing IconLYNPARZA and Placebo Dosing Icon

Patients were randomized to receive LYNPARZA or placebo for active maintenance

Eligibility criteria:
  • All patients had a deleterious or suspected deleterious germline BRCA mutation as detected by the Myriad BRACAnalysis® or BRACAnalysis CDx® at a central laboratory, a locally performed BRCA test, or both
  • ≥16 weeks of first-line platinum-based chemotherapy with no limit to duration, without evidence of disease progression (complete response, partial response, or stable disease)
Randomization
  • N=154 (no stratification)
  • 3:2
Treatment until disease progression or unacceptable toxicity
  • LYNPARZA 300 mg BID (n=92)
  • Placebo BID (n=62)

Trial endpoints

Primary endpoint
  • PFS (BICR per modified RECIST, version 1.1)
Select secondary endpoints
  • OS
  • ORR (BICR per modified RECIST, version 1.1)
Safety objective
  • Safety and tolerability

Prior treatment

  • Previous chemotherapy (N=154): 75% received FOLFIRINOX, 12% received variants of FOLFIRINOX, and 3% received gemcitabine plus cisplatin
  • A complete or partial response to first-line platinum-based chemotherapy was seen in 49% of patients (N=154)

*Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.1

LYNPARZA POLO Trial Progression-Free Survival Header LYNPARZA POLO Trial Progression-Free Survival Header
LYNPARZA POLO Trial Progression-Free Survival Kaplan-Meier Curve LYNPARZA POLO Trial Progression-Free Survival Kaplan-Meier Curve
In POLO, PFS was defined as the time from randomization to disease progression or death from any cause. In the LYNPARZA arm (n=92), there were 55 progression events and 5 death events. Deaths occurred before BICR-documented progression. In the placebo arm (n=62), there were 44 progression events and no deaths.

Estimated proportion of patients who were progression free through 24 months2†

†Based on Kaplan–Meier estimates.

These analyses are descriptive only; the POLO trial was not powered to assess a statistical difference between treatment groups at these timepoints.

SECONDARY ENDPOINT: OS IN THE POLO TRIAL1

  • The final analysis of OS did not reach statistical significance (HR=0.83, 95% CI: 0.56–1.22, P=0.3487). Events (%): 61 (66) for LYNPARZA and 47 (76) for placebo. Median overall survival was 19.0 months (95% CI: 15.3–26.3) for LYNPARZA vs 19.2 months (95% CI: 14.3–26.1) for placebo.
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Evaluating ORR by BICR

Patients evaluated had measurable disease at baseline (as determined by mRECIST v1.1).

Approximately 84% of patients in the POLO study had measurable disease at baseline after receiving first-line platinum-based chemotherapy.

Almost 1 in 4 patients in the LYNPARZA group with measurable disease after first-line platinum-based chemotherapy achieved a response (vs almost 1 in 8 in the placebo group), including 2 conversions to complete response.

The median duration of response in patients with measurable disease who responded to LYNPARZA was >2 years after platinum-based chemotherapy1,2*

*Developed an objective response to LYNPARZA as determined by BICR per mRECIST v1.1.