(Rectal Cancer) Nivolumab (Opdivo) After Chemoradiotherapy: VOLTAGE Trial Results

• August 19, 2019
• 2 min read

At the ESMO World Congress on Gastrointestinal Cancer (WCGC 2019), held in Barcelona, Spain from July 3–6, 2019, Takayuki Yoshino presented results from the VOLTAGE trial: "Efficacy and safety of nivolumab (anti-PD-1 antibody) monotherapy following preoperative chemoradiotherapy in microsatellite-stable (MSS) resectable locally advanced rectal cancer patients."

Trial Design:

VOLTAGE was a physician-led, open-label, single-arm trial enrolling patients with microsatellite-stable (MSS; Cohort A1, N=39) and high microsatellite instability (MSI-H; Cohort A2, N=2) resectable locally advanced rectal cancer. Following chemoradiotherapy (capecitabine + 50 Gy), patients received nivolumab 240 mg monotherapy every 2 weeks for 5 cycles within 14 days. The primary endpoint was pathological complete response rate (pCR) by independent central review (expected pCR: 30%); secondary endpoints included per-institution pCR and R0 resection rate.

Results (Cohort A1, N=37 evaluable):

• Primary endpoint pCR (independent central review): 30% (11/37 patients)

pCR by PD-L1 expression (MSS group):

• PD-L1 ≥1%: 60%
• PD-L1 <1%: 19%

CD8/eTreg ratio from pre-chemoradiotherapy biopsy correlated with pCR:

• CD8/eTreg ratio ≥2: pCR 62%
• CD8/eTreg ratio <2: pCR 10%

Safety:

Overall adverse event rate: 51.3%. Grade 3–4 adverse events: 7.7%.

Conclusion: Based on the VOLTAGE trial results, Takayuki Yoshino concluded that nivolumab monotherapy following preoperative chemoradiotherapy achieved the primary endpoint of 30% pCR in microsatellite-stable resectable locally advanced rectal cancer patients.

Source: ESMO WCGC 2019

Rectal Cancer | Immunotherapy | Nivolumab | VOLTAGE Trial

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