|The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2021 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Results from a long-term survival analysis of the ATTRACTION-1 study demonstrated nivolumab’s enduring efficacy in patients with advanced esophageal squamous cell carcinoma (ESCC), according to data based on a minimum of 5 years of follow-up presented at the 2021 Gastrointestinal Cancers Symposium.
A total of 65 patients with advanced ESCC who were either refractory to or could not tolerate fluoropyrimidine-, platinum-, and taxane-based therapy enrolled on the phase 2 ATTRACTION-1 trial between February 25, 2014 and November 14, 2014, and 64 were evaluated for treatment efficacy. At the final database lock for long-term follow-up analysis on August 6, 2020, 17.2% of patients were found to have an objective response by central assessment (95% CI, 9.9-28.2), reported Ken Kato, MD, PhD, of National Cancer Center Hospital in Japan.
The median overall survival (OS) was 10.8 months (95% CI, 7.4-13.9), and the estimated 5-year OS rate was 6.3% (95% CI, 2.0-14.0). The median progression-free survival (PFS) wasn1.5 months (95% CI, 1.4-2.8). The estimated 5-year PFS rate was 6.8% (95% CI, 2.2-15.1). These findings represent the longest follow-up of patients with advanced ESCC treated with nivolumab, according to Kato, who added that “long-term survivors tended to show [a] deeper response.”
Importantly, no new safety signals were identified during the longer follow-up period. The most common treatment-related adverse events (frequency of >10%) were diarrhea and rash.
The findings, which are consistent with those for nivolumab in other disease settings, build on 2-year follow-up data from ATTRACTION-1, which previously demonstrated nivolumab’s capacity to induce antitumor activity with a manageable safety profile.
Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study. This clinical trial was supported by Ono Pharmaceutical and Bristol-Myers Squibb.
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Kato K, Doki Y, Ura T, et al. Nivolumab in advanced esophageal squamous cell carcinoma (ATTRACTION-1/ONO-4538-07): minimum of five-year follow-up. Poster presented at Gastrointestinal Cancer Symposium; January 15-17, 2021. Abstract 207.