Trial results for the REMAIN trial (NCT02275533) investigating nivolumab to prevent disease recurrence in patients with acute myeloid leukemia were posted on ClinicalTrials.gov on 2025-11-06. The study showed that patients treated with nivolumab achieved a median overall survival of 53.9 months, compared to 30.9 months for those in the observation arm.
Background
Nivolumab is an immunotherapy with monoclonal antibodies. It is designed to help the body's immune system attack cancer cells and may interfere with the ability of tumor cells to grow and spread. This trial investigated its use in patients with acute myeloid leukemia who had achieved a decrease in or disappearance of signs and symptoms of cancer after receiving chemotherapy.
Trial design
The REMAIN trial (NCT02275533) was a Phase 2 study that enrolled 82 participants. The trial investigated nivolumab in patients with acute myeloid leukemia to prevent disease from returning after initial chemotherapy. Participants were assigned to either an Arm I (Nivolumab) group or an Arm II (Observation) group.
Key results
The trial results showed differences between the nivolumab and observation groups for several outcomes:
- For Progression Free Survival (PFS), the nivolumab arm (Arm I) had a median of 13.2 months, compared to 10.9 months for the observation arm (Arm II).
- For Overall Survival (OS), the nivolumab arm (Arm I) had a median of 53.9 months, compared to 30.9 months for the observation arm (Arm II).
- Non-relapse Mortality (NRM) was observed in 2 participants in the nivolumab arm and 1 participant in the observation arm.
- The incidence of adverse effects was reported in 27 participants in the nivolumab arm, compared to 5 participants in the observation arm.
Key analyses included:
- A Log Rank analysis yielded a Hazard Ratio (HR) of 0.92 (95.0% CI: 0.54 to 1.56) with a p-value of 0.38.
- Another Log Rank analysis yielded a Hazard Ratio (HR) of 0.78 (95.0% CI: 0.4 to 1.51) with a p-value of 0.23.
- A Fisher Exact analysis resulted in a p-value of 0.001.
What this means
The results from the REMAIN trial suggest that nivolumab may offer an improvement in overall survival for patients with acute myeloid leukemia after chemotherapy, with a median overall survival of 53.9 months compared to 30.9 months in the observation group. While progression-free survival also showed a numerical increase, the statistical analyses for hazard ratios did not reach conventional significance levels. A Fisher Exact analysis did show a statistically significant difference (p-value of 0.001) for an unspecified outcome. The higher incidence of adverse effects in the nivolumab arm compared to observation is also a consideration for clinical practice.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02275533, titled "Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial," were posted on 2025-11-06 on clinicaltrials.gov.