ClinicalTrials.gov recorded primary completion on 13 February 2023 for a Phase 3 study of atezolizumab plus tiragolumab with paclitaxel and cisplatin in esophageal carcinoma. The trial enrolled 461 participants and reported median investigator-assessed progression-free survival of 7.00 months with the atezolizumab combination versus 5.45 months with placebo plus paclitaxel and cisplatin.

Background

The study evaluated atezolizumab in combination with tiragolumab, paclitaxel, and cisplatin as first-line treatment for participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma. The comparator regimen included atezolizumab-matching placebo, tiragolumab-matching placebo, paclitaxel, and cisplatin. The condition listed in the registry was esophageal cancer.

Trial design

This was a completed Phase 3 study with 461 participants. Participants were randomized in a 1:1 ratio to receive either atezolizumab plus tiragolumab with paclitaxel and cisplatin, or matching placebos with paclitaxel and cisplatin, during induction treatment. The study assessed efficacy and safety as first-line treatment.

Key results

Investigator-assessed median progression-free survival was 7.00 months with atezolizumab plus tiragolumab and chemotherapy versus 5.45 months with placebo plus chemotherapy. A reported log-rank analysis showed a hazard ratio of 0.57, with a 95% confidence interval of 0.46 to 0.72 and p=0.0001.

Independent review facility-assessed confirmed objective response rates were 59.7% for the atezolizumab combination and 45.5% for placebo plus chemotherapy. Investigator-assessed response rates were 55.9% and 41.4%, respectively. Reported differences in overall response rates were 14.24 percentage points with p=0.0025 and 14.52 percentage points with p=0.0017; the associated 95% confidence intervals were 4.68 to 23.45 and 5.08 to 23.6.

Median independent review facility-assessed duration of response was 7.10 months versus 4.34 months. Investigator-assessed duration of response was 8.31 months versus 5.78 months. Median time to confirmed deterioration in participant-reported physical functioning was 16.10 months with the atezolizumab combination and 15.80 months with placebo plus chemotherapy.

What this means

The registry results showed longer progression-free survival, higher objective response rates, and longer response duration for the atezolizumab-plus-tiragolumab regimen with paclitaxel and cisplatin than for placebo plus chemotherapy in this study population. The supplied data do not include an adverse-event summary or establish a new regulatory approval or indication.

Source

Source: ClinicalTrials.gov, registry record for NCT04540211, “A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment” in esophageal carcinoma. The primary-completion event was dated 13 February 2023. The record is available at clinicaltrials.gov/study/NCT04540211.