(Gastric Cancer) Is Keytruda ± Chemotherapy Effective?

• October 2, 2020
• Reading time: 2 minutes

On September 3, 2020, Kohei Shitara published results in JAMA Oncology from the KEYNOTE-062 Phase 3 clinical trial comparing pembrolizumab (Keytruda) monotherapy and pembrolizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment in advanced gastric or gastroesophageal junction (G/GEJ) cancer patients.

The KEYNOTE-062 Phase 3 trial randomized advanced G/GEJ cancer patients (N=763) in a 1:1:1 ratio to three first-line treatment arms. Primary endpoints were PFS and OS in PD-L1-positive (CPS ≥1 and CPS ≥10) populations.

1. Pembrolizumab monotherapy arm: Keytruda 200 mg every 3 weeks (N=256)
2. Pembrolizumab + chemotherapy arm: Keytruda 200 mg every 3 weeks + chemotherapy (N=257)
3. Placebo arm: placebo + chemotherapy (N=250)

Results at median follow-up of 29.4 months:

Overall Survival (Primary Endpoint) in PD-L1-positive (CPS ≥1): Median OS was 10.6 months (pembrolizumab monotherapy) / 12.5 months (pembrolizumab + chemotherapy) / 11.1 months (placebo). Although the pembrolizumab monotherapy arm performed better than the placebo arm, superiority was not demonstrated.

Overall Survival in PD-L1-positive (CPS ≥10): Median OS was 17.4 months (pembrolizumab monotherapy) / 12.3 months (pembrolizumab + chemotherapy) / 10.8 months (placebo). Superiority of pembrolizumab was not demonstrated.

Safety: Grade 3–5 adverse events occurred in 17% (pembrolizumab monotherapy) / 73% (pembrolizumab + chemotherapy) / 69% (placebo).

Based on the KEYNOTE-062 trial results, Kohei Shitara concluded that pembrolizumab monotherapy and pembrolizumab plus chemotherapy as first-line treatment for advanced G/GEJ cancer showed better OS than the placebo arm, with a lower incidence of adverse events in the monotherapy arm.

Source: Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer — The KEYNOTE-062 Phase 3 Randomized Clinical Trial (JAMA Oncol. 2020 Sep 3. doi:10.1001/jamaoncol.2020.3370)

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