Phase 3 trials have demonstrated ≤14 months mOS, underscoring unmet needs1-12
In patients with unresectable, advanced, or metastatic upper GI cancers and positive PD-L1 scores,
Despite treatment advances in recent years, key outcomes of 1L treatment success remain low and limited in phase 3 clinical trials with previously approved PD-1–inhibitor and chemotherapy combinations as well as for chemotherapy alone.
In 1L ESCC:
- <14 months mOS in patients with a positive PD-L1 score receiving immunotherapy and chemotherapy combinations, or chemotherapy alone, in phase 3 clinical trials*
- Patients with advanced or metastatic ESCC also face debilitating symptoms, such as dysphagia, which can lead to cachexia
In 1L GC/GEJC:
- ≤14 months mOS in patients with a positive PD-L1 score receiving immunotherapy and chemotherapy or chemotherapy alone in pivotal trials†
- ~50% of patients present with peritoneal metastases, a poor prognostic factor. It is difficult for patients with peritoneal metastases to remain on treatment, and no phase 3 trial of immunotherapy has reported positive survival using a PD-L1 score cutoff of ≥1%,‡ potentially owing to the immunosuppressive, macrophage-rich environment in the peritoneum
In 1L ESCC:
- Less than 14 months mOS in patients with a positive PD-L1 score receiving immunotherapy and chemotherapy combinations, or chemotherapy alone, in phase 3 clinical trials*
- Patients with advanced or metastatic ESCC also face debilitating symptoms, such as dysphagia, which can lead to cachexia
In 1L GC/GEJC:
- 14 months or less mOS in patients with a positive PD-L1 score receiving immunotherapy and chemotherapy or chemotherapy alone in pivotal trials†
- Despite the difficulty in detecting widespread disease, it is estimated that ~50% of patients present with peritoneal metastases. It is difficult for patients with peritoneal metastases to remain on treatment, and no phase 3 trial of immunotherapy has reported favorable survival using a PD-L1 score cutoff of ≥1%,‡ potentially owing to the immunosuppressive, macrophage-rich environment in the peritoneum
Patients with certain advanced or metastatic upper GI cancers need 1L treatment options that can extend survival further
*Phase 3 clinical trials include CHECKMATE-648, KEYNOTE-590, and REAL-2. Median overall survival of less than 14 months represents analyses of patients with CPS scores ≥1.
†Pivotal trials include CHECKMATE-649, KEYNOTE-859, and REAL-2. Median overall survival of 14 months or less represents analyses of patients with CPS scores ≥1.
‡Phase 3 clinical trials include ATTRACTION-04, CHECKMATE-649, and KEYNOTE-859.
1L, first line; CPS, combined positive score; ESCC, esophageal squamous cell carcinoma; GC, gastric cancer; GEJC, gastroesophageal junction cancer; GI, gastrointestinal; mOS, median overall survival; PD-1, programmed death receptor 1; PD-L1, programmed death ligand 1.
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