New data from the GALLIUM Phase 3 trial (NCT01332968) shows that follicular lymphoma patients who progress within two years of immunochemotherapy have a 26-fold increased risk of death, compared to those without progression during that time.
A poster with these findings, “Early Disease Progression Predicts Poorer Survival in Patients with Follicular Lymphoma (FL) in the GALLIUM Study.” will be presented during the 59th ASH Annual Meeting, set for Dec. 9-12,in Atlanta.
Researchers had suspected that early disease progression in follicular lymphoma could be linked to increased risk of death during the multi-center, observational National LymphoCare Study (NCT00097565).
That trial, sponsored by Genentech — a division of the Roche Group — showed that follicular lymphoma patients who progressed within the first two years of treatment with Rituxan (rituximab) plus chemotherapy were 6.4 times more likely to die than patients without early disease progression. To further confirm the findings, researchers conducted an exploratory analysis to assess whether early disease progression also predicted overall survival in GALLIUM.
The ongoing Phase 3 trial is comparing the safety and efficacy of two CD20 antibodies — Gazyva (obinutuzumab) and Rituxan — combined with chemotherapy in patients with previously untreated advanced non-Hodgkin’s lymphoma.
Researchers had already reported that Gazyva treatment prolonged the time to disease progression. But researchers more recently have learned that regardless of one’s treatment, follicular lymphoma patients who progressed early had significantly worse survival outcomes.
Among the 1,202 follicular lymphoma patients included in GALLIUM, 155 had disease progression or died from the disease within the first 24 months after randomization. Surprisingly, patients who progressed early had a 26-fold increase in their risk of death after the progression event, and 12-fold higher risk of death compared to patients who did progress within that time. However, the treatment regimen did not influence post-progression survival.
At 24 months, 18.9 percent of patients receiving Rituxan got worse or died, compared to 12.5 percent in the Gazyva arm, which supported prior findings.
Overall the GALLIUM study data showed that early progression in follicular lymphoma patients predicts poor survival outcomes, in accordance with previous observations.
“The sooner progression occurs, the greater the mortality risk,” researchers wrote, “but early progresses cannot be identified in advance.”