Primary completion results for a Phase 3 study evaluating the nivolumab and regorafenib combination (RegoNivo) in gastro-oesophageal cancer were posted on ClinicalTrials.gov on 2025-01-14. The trial compared RegoNivo to standard of care chemotherapy, with the RegoNivo arm showing a median overall survival of 5.91 months compared to 6.28 months for the standard of care.
Background
This study investigated the combination of nivolumab and regorafenib (RegoNivo) for participants with refractory gastro-oesophageal cancer (AGOC). The trial aimed to determine if this combination could improve overall survival compared with current standard chemotherapy options in this patient population.
Trial design
The Phase 3 study (NCT04879368) enrolled 462 participants with gastro-oesophageal cancer. The trial's primary objective was to determine if the regorafenib and nivolumab combination (RegoNivo) improved overall survival compared with current standard chemotherapy options in refractory AGOC. The experimental arm received regorafenib and nivolumab, while the control arm received standard of care chemotherapy, which included docetaxel, paclitaxel, or irinotecan.
Key results
The trial reported the following key outcomes:
- Overall Survival (OS): The median OS for the RegoNivo arm was 5.91 Months, compared to 6.28 Months for the standard of care arm. A stratified log-rank test yielded a Hazard Ratio (HR) of 0.88 (95% Confidence Interval: 0.71, 1.09), with a p-value of 0.23.
- Progression-Free Survival (PFS): Median PFS was 1.91 Months for RegoNivo and 1.87 Months for standard of care. The Hazard Ratio (HR) for PFS was 0.85 (95% Confidence Interval: 0.69, 1.05).
- Overall Tumor Response Rate (OTRR): The RegoNivo arm had 23 participants with complete or partial response, while the standard of care arm had 4 participants. The Odds Ratio (OR) was 2.99 (95% Confidence Interval: 1.0, 12.11).
- Deterioration-Free Survival (DFS) Based on Physical Function (EORTC QLQ-C30): The percentage of participants in the RegoNivo arm was 6.9% and 3.9%, compared to 6.3% and 0.7% in the standard of care arm. The Hazard Ratio (HR) was 0.86 (95% Confidence Interval: 0.7, 1.05).
- Deterioration-Free Survival Rate Based on Global Health Status (EORTC QLQ-C30): The RegoNivo arm showed 6.9% of participants, versus 5.6% in the standard of care arm. The Hazard Ratio (HR) was 0.74 (60% Confidence Interval: 0.6, 0.91).
What this means
The results of this Phase 3 trial indicate that the combination of nivolumab and regorafenib (RegoNivo) did not demonstrate a statistically significant improvement in overall survival for patients with refractory gastro-oesophageal cancer compared to standard of care chemotherapy. The median overall survival was numerically lower in the RegoNivo arm (5.91 Months) than in the standard of care arm (6.28 Months), and the Hazard Ratio of 0.88 with a p-value of 0.23 suggests no significant benefit. Progression-free survival was also comparable between the two arms. While the overall tumor response rate was higher with RegoNivo (23 participants vs 4 participants), this did not translate into a statistically significant overall survival advantage. These findings suggest that RegoNivo may not offer a superior treatment option over existing standard chemotherapy for this patient population based on the primary endpoint.
Source
The information regarding these primary completion results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04879368, titled "RegoNivo vs Standard of Care Chemotherapy in AGOC", were posted on 2025-01-14 on clinicaltrials.gov.