|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Adjuvant nivolumab provided “clinically meaningful efficacy” in a phase 3 trial of patients with esophageal cancer (EC) or gastroesophageal junction cancer (GEJC), according to a presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.1
These results, an update of the CheckMate 577 trial (ClinicalTrials.gov Identifier: NCT02743494), were presented by Ronan Joseph Kelly, MD, of Baylor University Medical Center in Dallas.
The randomized, double-blind trial included 794 patients with resected stage II-III EC or GEJC who had received neoadjuvant chemoradiotherapy and had residual pathologic disease.
Patients were randomized to nivolumab at 240 mg (n = 532) or placebo (n = 262) every 2 weeks for 16 weeks, followed by nivolumab at 480 mg or placebo every 4 weeks.
The study’s primary results, which were published earlier this year2, showed that the median disease-free survival doubled with nivolumab versus placebo — 22.4 months and 11 months, respectively (hazard ratio [HR], 0.69; 96.4% CI, 0.56 to 0.86; P <.001).
The data Dr Kelly presented at ASCO 2021 showed that distant recurrence was lower with nivolumab versus placebo (29% and 39%, respectively), as was locoregional recurrence (12% and 17%, respectively).
The median distant metastasis-free survival was 28.3 months with nivolumab and 17.6 months with placebo (HR, 0.74; 95% CI, 1.60-0.92).
The median progression-free survival 2 (defined as time from randomization to progression after subsequent systemic therapy, initiation of second subsequent systemic therapy, or death, whichever is earlier) was not reached with nivolumab and was 32.1 months with placebo (HR, 0.77; 95% CI, 0.60-0.99).
Nivolumab was well-tolerated for both low-grade and high-grade events, Dr Kelly said.
Most treatment-related adverse events (TRAEs) with potential immunologic etiology (select TRAEs) reported for nivolumab were grade 1 or 2. Grade 3–4 select TRAEs occurred in 1% of patients or fewer, and none of these events were grade 5.
“This is important information to assess because this is the first study of nivolumab in early-stage upper-GI cancers, and it’s unclear if the immune microenvironment differs from that in metastatic disease, which may impact adverse events,” Dr Kelly said. “Select treatment-related adverse events in the nivolumab group occurred early and resolved for most patients with the use of established management algorithms.”
Similar trends in improvement of quality of life were observed in the nivolumab and placebo arms during treatment and were maintained post-treatment.
“Adjuvant nivolumab demonstrated clinically meaningful efficacy . . . , demonstrated an acceptable safety profile, and maintained quality of life,” Dr Kelly said. “These results provide further support for adjuvant nivolumab as a new standard of care for patients with resected esophageal or gastroesophageal junction cancers who received neoadjuvant chemoradiotherapy with residual pathologic disease.”
Disclosures: This research was supported by Bristol Myers Squibb. Study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Read more of Cancer Therapy Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
- Kelly RJ, Ajani JA, Kuzdzal J, et al. Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577. J Clin Oncol. 2021;39:(suppl 15; abstr 4003). doi:10.1200/JCO.2021.39.15_suppl.4003
- Kelly RJ, Ajani JA, Kuzdzal J et al. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med 2021; 384:1191-1203. doi:10.1056/NEJMoa2032125