Author of

• 25899

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  MA10 - Considerations in Immunotherapy / Real World (ID 911)

  • Event: WCLC 2018
  • Type: Mini Oral Abstract Session
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 10:30 - 12:00, Room 105

  • 27899

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    MA10.08 - Choice of Taxane and Outcomes in the KEYNOTE-407 Study of Pembrolizumab Plus Chemotherapy for Metastatic Squamous NSCLC (ID 14698)

    11:25 - 11:30  |  Author(s): Xiaodong Li
    • Abstract
    • Presentation
    • Slides

    Background
    

    In the randomized, double-blind, phase 3 KEYNOTE-407 study (NCT02775435), pembrolizumab plus chemotherapy with carboplatin and paclitaxel or nab-paclitaxel significantly prolonged OS (HR 0.64, 95% CI 0.49-0.85, P=0.0008) and PFS (HR 0.56, 95% CI 0.45-0.70, P<0.0001) compared with placebo plus chemotherapy in patients with previously untreated, metastatic squamous NSCLC. The benefit of pembrolizumab plus chemotherapy was observed irrespective of PD-L1 TPS. Pembrolizumab plus chemotherapy also had a manageable safety profile. We performed an exploratory analysis of outcomes by investigator’s choice of paclitaxel or nab-paclitaxel, which was a randomization stratification factor.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    559 eligible patients were randomized 1:1 to pembrolizumab 200 mg or placebo Q3W for up to 35 cycles plus 4 cycles of carboplatin AUC 6 mg/mL/min Q3W and investigator’s choice of paclitaxel 200 mg/m² Q3W or nab-paclitaxel 100 mg/m² QW. Primary end points were OS and PFS; ORR and safety were secondary.

    4c3880bb027f159e801041b1021e88e8 Result
    

    Paclitaxel was the chosen taxane in 60% of patients. The addition of pembrolizumab to chemotherapy improved OS, PFS, and ORR regardless of choice of carboplatin and paclitaxel or carboplatin and nab-paclitaxel (Table). Incidence of grade 3-5 AEs in the pembrolizumab plus chemotherapy arm vs placebo plus chemotherapy arm was 63.9% vs 59.3% in paclitaxel recipients and 78.9% vs 81.4% in nab-paclitaxel recipients. AEs led to discontinuation of all treatment in 13.6% vs 8.4% of paclitaxel recipients and 12.8% vs 3.5% of nab-paclitaxel recipients and led to discontinuation of any treatment in 19.5% vs 13.2% and 29.4% vs 9.7%, respectively. Immune-mediated AEs occurred in 29.6% vs 9.6% of paclitaxel recipients and 27.5% vs 7.1% of nab-paclitaxel recipients.

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Adding pembrolizumab to chemotherapy with carboplatin and a taxane improved efficacy and was generally tolerable compared with chemotherapy alone as first-line therapy in patients with metastatic squamous NSCLC regardless of whether paclitaxel or nab-paclitaxel was the chosen taxane.

    	Carboplatin plus Paclitaxel		Carboplatin plus Nab-Paclitaxel
    	Pembrolizumab + Chemotherapy N = 169	Placebo + Chemotherapy N = 167	Pembrolizumab + Chemotherapy N = 109	Placebo + Chemotherapy N = 114
    OS, median (95% CI), mo	14.0 (12.6-16.6)	10.3 (8.2-14.8)	NR (NE-NE)	12.6 (9.6-NE)
    HR (95% CI)a	0.67 (0.48-0.93)		0.59 (0.36-0.98)
    PFS, median (95% CI), mo	6.4 (6.0-8.3)	4.4 (4.2-5.1)	6.5 (6.2-8.5)	5.9 (4.4-6.9)
    HR (95% CI)a	0.52 (0.40-0.68)		0.65 (0.45-0.94)
    ORR, % (95% CI)	57.4 (49.6-65.0)	37.7 (30.4-45.5)	58.7 (48.9-68.1)	39.5 (30.4-49.1)
    aBased on a Cox regression model with treatment as a covariate.

    6f8b794f3246b0c1e1780bb4d4d5dc53

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