Efficacy data

Lynparza can help maintain disease control vs. placebo4,6

 

In study 19, which investigated women with PSR ovarian cancer, Lynparza capsules, compared to placebo, was shown to:

  • Significantly reduce the risk of death or disease progression by 65% (HR 0.35; 95% CI = 0.25-0.49; p<0.0001)6
  • Improve median PFS by 3.6 months (8.4 vs 4.8 months) (HR 0.35; 95% CI = 0.25-0.49; p<0.0001)6

Lynparza was also shown to extend PFS, regardless of BRCAm status.6

About the… PFS data from Study 19 by BRCA status

Lynparza improves progression-free survival regardless of BRCAm status1

 

This is an exploratory analysis

SOLO-2: Provides confirmatory evidence of the effect of LYNPARZA tablets in gBRCAm patients4

 

In a further clinical study, SOLO2, which investigated women with gBRCAm PSR ovarian cancer, Lynparza tablets, compared to placebo, was shown to:

  • Significantly reduce risk of disease progression or death by 70% (HR = 0.30; 95% CI = 0.22-0.41; p<0.0001)4
  • Improve median PFS by 13.6 months (19.1 months versus 5.5 months)4

Benefit of Lynparza can be observed in further intermediate efficacy endpoints vs. placebo4,7

Benefit of Lynparza was also seen across a range of further intermediate efficacy endpoints. in both studies including time to first subsequent treatment (TFST), progression free survival 2 / time to second progression (PFS2) and time to second subsequent treatment (TSST).4,7

About the… Further efficacy endpoints in Study 19 and SOLO2

Summary of efficacy endpoints in Study 196

There was no strategy for multiple testing in place for the sub-group analyses or for the all patients TFST and TSST, thus all p values are nominal.

Lynparza extends time to first subsequent therapy in PSR ovarian cancer6

 

In Study 19, Lynparza extended TFST*† compared to placebo in the overall population6

  • 6.7 month improvement in median TFST comparted to placebo (HR=0.39, 95% CI (0.29-0.51); p<0.0001) (nominal)6

*There was no strategy for multiple testing in place for the sub-group analyses or for the all patients TFST and TSST, thus all p values are nominal.

In Study 19, TSFT was a post-hoc exploratory endpoint

Data cut-off 30th September 2015

Patients treated with Lynparza saw an extension in time to their second subsequent treatment6

 

In Study 19, Lynparza extended TSST*† compared to placebo in the overall population6

  • 4.3 month improvement in median time to second therapy (HR=0.52, 95% CI (0.39-0.68); p<0.0001) (nominal)6

*There was no strategy for multiple testing in place for the sub-group analyses or for the all patients TFST and TSST, thus all p values are nominal.

In Study 19, TSFT was a post-hoc exploratory endpoint

Data cut-off 30th September 2015

Overall survival with Lynparza treatment in PSR ovarian cancer5

 

  • The final OS analysis in the overall population did not reach statistical significance* (HR=0.73; 95% Cl (0.55-0.96); P=0.02138)5
  • With a median follow up duration for OS of 6.5 years, the Lynparza OS analysis represents the most comprehensive dataset with the longest follow-up for patients treated with a PARP inhibitor5

*The p-value did not reach the required significance threshold for this analysis Data cut-off May 2016

Summary of efficacy endpoints in SOLO24

Data cut-off 19th September 2016 for all endpoints

Similar to Study 19, Lynparza extended TSFT in patients with gBRCAm PSR ovarian cancer4

 

In SOLO2, Lynparza significantly improved TFST compared to placebo4

20.8 month improvement in median TFST compared to placebo (HR=0.28, 95% CI (0.21-0.38); p<0.0001)4

Data cut-off 19th September 2016

The benefits of Lynparza treatment in SOLO2 could be observed in further intermediate efficacy endpoints4

 

  • Median time to PFS2 was significantly extended in gBRCAm PST patients, compared with placebo (HR=0.50, 95% CI (0.34-0.72); p<0.0002)4

Data cut-off 19th September 2016

Lynparza treatment provided patients with more time until their second subsequent therapy4

 

  • TSST was significantly extended in gBRCAm PST patients treated with Lynparza, compared with placebo (HR=0.37, 95% CI (0.26-0.53); p<0.0001)4

Data cut-off 19th September 2016

Overall survival data for SOLO2 remains immature4

 

A final analysis of OS will take place at ~177 events (60% OS maturity)4

Full assessment set n=295, Data cut-ff 19th September 2016

Data maturity 24%

In Study 19, the final overall survival (OS) analysis did not meet the threshold for significance (HR=0.73 (95% CI: 0.55-0.96);p=0.02).5

OS data for SOLO2 remain immature.4

Long-term follow-up shows benefit in some patients for more than 6 years5

With more than 6 years follow-up data from Study 19, Lynparza (capsules) is the only PARP inhibitor that has demonstrated long-term disease control, with a generally well-tolerated and manageable safety profile.2,5

 

After 6 years follow-up in Study 19, 11% of PSR ovarian cancer patients remained on Lynparza treatment at 6 years.5