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KEYNOTE-604: Very durable responses on pembrolizumab plus EP in SCLC

Presented by
Dr Charles Rudin, Memorial Sloan Kettering Cancer Center, NY, USA
WCLC 2022
Phase 3, KEYNOTE-604
Long-term follow-up data of the phase 3 KEYNOTE-604 trial displayed an ongoing clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with extensive-stage small cell lung cancer (ES-SCLC) if they received pembrolizumab plus etoposide/platinum (EP) chemotherapy instead of EP alone [1].

The KEYNOTE-604 trial (NCT03066778) compared the efficacy and safety of pembrolizumab plus EP with placebo plus EP in the first-line treatment of patients with ES-SCLC (n=453). A significant PFS benefit of the experimental therapy over the control therapy was reported in the published results of the primary analysis (HR 0.75; P=0.0023) [2]. Dr Charles Rudin (Memorial Sloan Kettering Cancer Center, NY, USA) presented the updated results with 3.5 years of additional follow-up.

After a median follow-up of 43.3 months, the median OS was 10.8 months in the experimental arm versus 9.7 months in the control arm (HR 0.76; 95% CI 0.53–0.93). The corresponding 3-year OS rates were 15.5% and 5.9%. Likewise, the PFS data demonstrated that the combination therapy was superior to the monotherapy (median PFS 4.8 vs 4.3 months; HR 0.70; 95% CI 0.57–0.85). Dr Rudin commented that patients had received at maximum 24 months of treatment, but that 6.9% of the patients in the experimental arm was still progression-free at 36 months, distinguishing a subset of patients with very durable responses. Only 0.5% of the patients in the placebo arm was progression-free 3 years after randomisation. All in all, these results encourage the further exploration of pembrolizumab-based combinations in the ES-SCLC population.

  1. Rudin CM, et al. First line pembrolizumab or placebo combined with etoposide and platinum for ES-SCLC: KEYNOTE-604 long-term follow-up results. OA12.06, WCLC 2022, Vienna, Austria, 06–09 August.
  2. Rudin CM, et al. J Clin Oncol. 2020 Jul 20;38(21):2369-2379.


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