Author of

• 30446

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  P1.01 - Advanced NSCLC (ID 158)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall

  • 30530

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    P1.01-73 - An Explorative Analysis of Pemetrexed +/- Pembrolizumab Maintenance from KEYNOTE-189 Versus PARAMOUNT, PRONOUNCE, and JVBL (ID 756)

    09:45 - 18:00  |  Author(s): Rocio Varea
    • Abstract
    • Slides

    Background
    

    Recently, the phase 3 KEYNOTE-189 study demonstrated improved progression-free survival (PFS) and overall survival (OS) when pemetrexed/platinum doublet was combined with pembrolizumab as first-line treatment in patients with non-squamous NSCLC. The specific benefits of maintaining pemetrexed in combination with pembrolizumab after the triplet with platinum has not been previously assessed.

    Method
    

    Using patient level data, we selected patients who had ≥5 cycles of pemetrexed (including the induction phase with platinum) from 3 randomized non-pembrolizumab clinical trials (PARAMOUNT, PRONOUNCE, and JVBL; N=486). As such, patients in the KEYNOTE-189 trial who had ≥5 cycles of pemetrexed in both arms (placebo arm; N=135, versus pembrolizumab arm; N=310) were analyzed. PFS and OS were evaluated by Kaplan-Meier estimator and Cox proportional hazard model; treatment emergent adverse events (TEAEs) were compared by descriptive statistics.

    Result
    

    Baseline characteristics of the selected population with ≥5 cycles of pemetrexed were comparable between the pooled trials and KEYNOTE-189. Median PFS for patients with ≥5 cycles of pemetrexed was 5.6 months (95% CI: 4.6-5.8) from the pooled non-pembrolizumab trials and 6.6 months (95% CI: 5.4-7.1) in the placebo plus pemetrexed/platinum arm in KEYNOTE-189 (un-stratified HR: 1.29; 95% CI: 1.02-1.62). Median PFS in the selected population with ≥5 cycles of pemetrexed in KEYNOTE-189 was 9.3 months (95% CI: 9.0-11.1) in the pembrolizumab plus pemetrexed/platinum arm, and when compared with the placebo plus pemetrexed/platinum arm in KEYNOTE-189, resulted in an un-stratified HR of 0.53 (95% CI: 0.42-0.68). Incidence rates of TEAEs were similar in those 3 selected populations (Table 1).

    

    Conclusion
    

    In a selected population with pemetrexed maintenance in KEYNOTE-189, the placebo arm showed numerically comparable efficacy with historical data on pemetrexed maintenance. Pemetrexed/platinum in combination with pembrolizumab proved consistent clinical benefit in the same population with ≥5 cycles of pemetrexed, compared to the placebo arm in KEYNOTE-189 and historical controls.

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