Trial results for the combination of atezolizumab plus tiragolumab with paclitaxel and cisplatin (PC) in unresectable locally advanced, recurrent, or metastatic esophageal carcinoma were posted on ClinicalTrials.gov on 2026-04-09. The study demonstrated that the combination extended median overall survival to 15.74 months compared to 11.10 months for placebo plus PC, and improved median progression-free survival to 6.18 months versus 5.39 months.
Background
The study investigated atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin as a first-line treatment for participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma.
Trial design
The study (NCT04540211) was a Phase 3, randomized trial that enrolled 461 participants with esophageal cancer. Participants were randomized in a 1:1 ratio to receive either atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC), or atezolizumab matching placebo plus tiragolumab matching placebo with PC. The study evaluated efficacy and safety as first-line treatment for unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma.
Key results
The trial results showed improvements across several efficacy endpoints for the combination arm compared to placebo plus PC:
- Median Overall Survival (OS) was 15.74 months for the atezolizumab plus tiragolumab arm, compared to 11.10 months for the placebo arm.
- Independent Review Facility (IRF)-Assessed Progression-Free Survival (PFS) was a median of 6.18 months for the atezolizumab plus tiragolumab arm, versus 5.39 months for the placebo arm. Investigator-Assessed PFS was a median of 7.00 months for the atezolizumab plus tiragolumab arm, compared to 5.45 months for the placebo arm.
- IRF-Assessed Confirmed Objective Response Rate (ORR) was 59.7% for the atezolizumab plus tiragolumab arm, versus 45.5% for the placebo arm. Investigator-Assessed Confirmed ORR was 55.9% for the atezolizumab plus tiragolumab arm, compared to 41.4% for the placebo arm.
- IRF-Assessed Duration of Objective Response (DOR) was a median of 7.10 months for the atezolizumab plus tiragolumab arm, versus 4.34 months for the placebo arm.
Key analyses further supported these findings:
- For Overall Survival, a Log Rank analysis yielded a Hazard Ratio (HR) of 0.7 (95.0% CI: 0.55 to 0.88) with a p-value of 0.0024.
- For IRF-Assessed PFS, the HR was 0.56 (95.0% CI: 0.45 to 0.7) with a p-value of 0.0001, and for Investigator-Assessed PFS, the HR was 0.57 (95.0% CI: 0.46 to 0.72) with a p-value of 0.0001.
- The Difference in IRF-Assessed Overall Response Rates was 14.24 (95.0% CI: 4.68 to 23.45) with a p-value of 0.0025, and for Investigator-Assessed ORR, it was 14.52 (95.0% CI: 5.08 to 23.6) with a p-value of 0.0017.
- For IRF-Assessed DOR, a Log Rank analysis showed an HR of 1.08 (95.0% CI: 0.8 to 1.46) with a p-value of 0.6068.
What this means
The results from this Phase 3 study indicate that the combination of atezolizumab plus tiragolumab with paclitaxel and cisplatin significantly improved key efficacy outcomes, including overall survival and progression-free survival, in patients with unresectable locally advanced, recurrent, or metastatic esophageal carcinoma. The observed improvements in median OS, PFS, and ORR, along with statistically significant hazard ratios and p-values, suggest a potential clinical benefit for this treatment regimen in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04540211, titled "A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma," were posted on 2026-04-09 on clinicaltrials.gov.