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STATISTICALLY SIGNIFICANT IMPROVEMENT
IN OVERALL SURVIVAL12

Pembrolizumab with carboplatin and paclitaxel OR carboplatin and ABRAXANE vs placebo with carboplatin and paclitaxel OR carboplatin and ABRAXANE
Median overall survival in the ITT population was 15.9 months (95% CI:13.2, NE) in the pembrolizumab with carboplatin + paclitaxel OR carboplatin + ABRAXANE group vs 11.3 months (95% CI: 9.5-14.8) in the
placebo with carboplatin + paclitaxel OR carboplatin + ABRAXANE group (HR: 0.64 [95% CI: 0.49-0.85]; P=0.0017) Median overall survival in the ITT population was 15.9 months (95% CI:13.2, NE) in the pembrolizumab with carboplatin + paclitaxel OR carboplatin + ABRAXANE group vs 11.3 months (95% CI: 9.5-14.8) in the placebo with carboplatin + paclitaxel OR carboplatin + ABRAXANE group (HR: 0.64 [95% CI: 0.49-0.85]; P=0.0017)
Adverse events11

The most common adverse events (incidence ≥15%) in the KEYNOTE-407 study were anemia, alopecia, neutropenia, nausea, thrombocytopenia, diarrhea, decreased appetite, constipation, fatigue, asthenia, arthralgia, peripheral neuropathy, vomiting, cough, and dyspnea.

40% of the study population received ABRAXANE

Median OS was 15.9 months (95% CI: 13.2, NE) in the pembrolizumab combination group vs 11.3 months (95% CI: 9.5-14.8) in the placebo combination group (HR: 0.64 [95% CI: 0.49-0.85]*; P=0.0017)

Median progression-free survival (coprimary endpoint)

6.4 months (95% CI: 6.2-8.3) in the pembrolizumab combination group vs 4.8 months (95% CI: 4.3-5.7) in the placebo combination group (HR: 0.56; 95% CI: 0.45-0.70; P<0.0001).

  • *Based on the stratified Cox proportional hazard model.
  • Based on stratified log-rank test.
  •  NE=not estimable.

  • See the Subgroup Analysis by Taxane

    OVERALL SURVIVAL SUBGROUP ANALYSIS BY TAXANE-BASED DRUG (EXPLORATORY ANALYSIS)11

    FROM THE NEW ENGLAND JOURNAL OF MEDICINE
    Data cutoff April 3, 2018
    ABRAXANE: HR=0.59

    (95% CI: 0.36-0.98; n=events/patients, 65/223)

    Paclitaxel: HR=0.67

    (95% CI: 0.48-0.93; n=events/patients, 140/336)

    Treatment effect was observed with pembrolizumab and chemotherapy in prespecified stratification factors: region of enrollment, PD-L1 TPS, and taxane-based drug.

    Analysis Limitation:

    An exploratory analysis should not be interpreted to determine a treatment difference between arms in these selected subgroups, because of insufficient sample size and a higher probability of making a false-positive finding.

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Additional Information for Readers Provided by Celgene Corporation

The clinical trial described in this article served as the
basis for the approval for ABRAXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.

Please see Important Safety Information and Prescribing Information, including Boxed WARNING.

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