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KEYNOTE-407: PHASE III TRIAL IN FIRST-LINE SQUAMOUS mNSCLC REGARDLESS OF PD-L1 EXPRESSION11

KEYNOTE-407 study design12
Study design: KEYNOTE-407 was a randomized, placebo-controlled trial conducted in patients who had not previously received systemic therapy for metastatic disease and who had an ECOG of 0-1. A total of 559 patients were randomized 1:1 to receive either pembrolizumab (200 mg Day 1) combined with carboplatin (AUC 6 mg•min/mL Day 1) and paclitaxel (200 mg/m2 Day 1) or ABRAXANE (100 mg/m2 Days 1, 8, and 15) for each 21- day cycle for 4 cycles (n=278), followed by pembrolizumab 200 mg Q3W; or placebo (Day 1) combined with carboplatin (AUC 6 mg•min/mL Day 1) and paclitaxel (200 mg/m2 Day 1) or ABRAXANE (100 mg/m2 Days 1, 8, and 15) for each 21-day cycle for 4 cycles (n=281), followed by placebo Q3W. Patients randomized to the placebo and chemotherapy arm were offered pembrolizumab as a single agent at the time of disease progression.Study design: KEYNOTE-407 was a randomized, placebo-controlled trial conducted in patients who had not previously received systemic therapy for metastatic disease and who had an ECOG of 0-1. A total of 559 patients were randomized 1:1 to receive either pembrolizumab (200 mg Day 1) combined with carboplatin (AUC 6 mg•min/mL Day 1) and paclitaxel (200 mg/m2 Day 1) or ABRAXANE (100 mg/m2 Days 1, 8, and 15) for each 21- day cycle for 4 cycles (n=278), followed by pembrolizumab 200 mg Q3W; or placebo (Day 1) combined with carboplatin (AUC 6 mg•min/mL Day 1) and paclitaxel (200 mg/m2 Day 1) or ABRAXANE (100 mg/m2 Days 1, 8, and 15) for each 21-day cycle for 4 cycles (n=281), followed by placebo Q3W. Patients randomized to the placebo and chemotherapy arm were offered pembrolizumab as a single agent at the time of disease progression.
  • aPembrolizumab was administered prior to chemotherapy on Day 1.12

From the New England Journal of Medicine: Per the study design in KEYNOTE-407, patients who received paclitaxel also received premedication with a glucocorticoid, a type 1 antihistamine, and a type 2 antihistamine according to local guidelines; premedication with a glucocorticoid and antihistamines was not required for patients who received ABRAXANE.11*

  • Patients with autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks were ineligible12
  • *Per the ABRAXANE Prescribing Information, premedication for ABRAXANE may be needed in patients who have had a prior hypersensitivity reaction to ABRAXANE.
Key efficacy endpoints11
  • Overall survival
  • Progression-free survival
Randomization stratification12
  • PD-L1 tumor proportion score (TPS) (≥1% vs <1%)
  • Choice of taxane (ABRAXANE vs paclitaxel)
  • Geographic region of enrollment (East Asia vs non–East Asia)
  • TPS is the percentage of tumor cells with membranous PD-L1 staining, with <1% indicating PD-L1–negative status.11
  • ECOG=Eastern Cooperative Oncology Group; R=randomized.

ABRAXANE + carboplatin FOR First-line ADVANCED OR metastatic NSCLC, INCLUDING SQUAMOUS

ABRAXANE: Pivotal Phase III study

Established safety profile

The most common ARs (≥20%) of ABRAXANE in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.

ABRAXANE = carboplatin delivered significantly superior ORR vs paclitaxel:
ITT population8
  • 33% ABRAXANE (100 mg/m2 IV weekly on days 1, 8, and 15 of each 21-day cycle) + carboplatin (AUC=6 mg•min/mL IV Day 1 of each 21-day cycle) (n=170/521) 95% CI: 28.6%-36.7%
  • 25% Paclitaxel injection (200 mg/m2 IV, Day 1 of each 21-day cycle) + carboplatin (AUC=6 mg•min/mL IV, Day 1 of each 21-day cycle) (n=132/531); 95% CI: 21.2%-28.5
  • Median duration of response was 6.9 months vs 6.0 months (95% CI: 5.6-8.0 vs 5.6-7.1, respectively)
  • No statistically significant difference in OS between the 2 study arms (median OS 12.1 months vs 11.2 months, P=NS8)

P=0.005 (based on chi-square test).

ARs=adverse reactions; AUC=area under the curve; ITT=intent-to-treat; NS=not significant; ORR=overall response rate; OS=overall survival.

41% ORR in first-line squamous:
Squamous population
  • 41% ABRAXANE + carboplatin
    (n=94/229)
  • 24% Paclitaxel injection + carboplatin
    (n+54/221)
Response rate in other histologies

P=0.005 (based on chi-square test).

ARs=adverse reactions; AUC=area under the curve; ITT=intent-to-treat; NS=not significant; ORR=overall response rate; OS=overall survival.

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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 ABRXANE 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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