The combination treatment demonstrated survival and safety results similar to those of chemotherapy for patients with advanced, untreated follicular lymphoma.
Revlimid (lenalidomide) combined with Rituxan (rituximab) demonstrated durable and safe responses, comparable to chemotherapy, in patients with advanced, untreated follicular lymphoma, according to data from a phase 3 clinical trial.
Six-year data from the RELEVANCE trial— which were published in the Journal of Clinical Oncology — demonstrated an overall response rate (a percentage of patients with a partial or complete response to treatment) of 61% at a median follow up of 72 months with the combination of Revlimid and Rituxan (investigative group; 513 patients). There was also a complete response plus unconfirmed complete response rate (or the disappearance of cancer as a response to treatment) of 48%. And Rituxan plus chemotherapy (control group; 517 patients) resulted in a 65% overall response rate, with a complete response and unconfirmed complete response rate of 53%.
Progression-free survival (time during and after treatment when the patient lives without disease progression) was not found to significantly differ between the groups. With the additional follow-up since the initial analysis, the median progression-free survival had not yet been reached in either group. The six-year progression-free survival rate in the investigative group was 60% versus 59% in the control group.
The median overall survival (time from diagnosis or treatment start when patients are alive) was also not reached in either group; the estimated six-year overall survival rate in both groups was 89%. Of note, when median overall survival is not reached in a study, that indicates that at least 50% of patients were alive at the point researchers assessed this factor.
Event-free survival (time a patient lives after therapy without their disease coming back or getting worse) and time to next anti-lymphoma treatment were also not found to significantly differ between the treatment groups.
“(Revlimid plus Rituxan) provides an acceptable, long-term, chemotherapy-free alternative to (Rituxan)/chemotherapy on the basis of immunomodulation in patients with advanced untreated follicular lymphoma in need of treatment,” Dr. Franck Morschhauser of Hospital Claude Huriez in Lille, France, and colleagues wrote in a paper on the findings.
The multicenter, international, phase 3 trial enrolled patients with confirmed CD20-positive follicular lymphoma who needed treatment. Patients could not have received prior systemic treatment for their disease.
Patients were randomly assigned to Revlimid and Rituxan or Rituxan and chemotherapy followed by maintenance treatment with Rituxan.
Data from an exploratory analysis did not demonstrate significant differences between the three different Rituxan/chemotherapy groups in terms of progression-free survival or overall survival.
Across both study groups (1,030 patients), the median age was 59 years with 15% of patients older than 70 years of age. Moreover, 49% of patients were men, and 93% had an Ann Arbor stage 3 to 4 disease. Additionally, 15% were low risk, 36% were intermediate risk and 49% were high risk.
Ninety-nine percent of patients in the investigative group and 97% in the control group had received at least one dose of the study drug; 69% and 71% of patients, respectively, completed the full 120 weeks of treatment. Thirty-one percent of those in the investigative group prematurely discontinued treatment versus 29% of those in the control group. The most common reason for discontinuation was disease progression and toxicity.
Twelve percent of patients experienced relapse or disease progression within 24 months of initiation; this includes 67 patients in the investigative group and 57 patients in the control group.
Moreover, 206 patients received additional treatment following relapse; 107 of these patients were in the investigative group and 99 were in the control group. In the patients who received Revlimid and Rituxan, the overall response rate was 61% versus 59% in those who received Rituxan/chemotherapy; the complete response and unconfirmed complete response rates in these groups were 37% and 45%, respectively. There was not a statistical significance observed between the groups in terms of survival.
Data from analyses focused on specific groups within the study showed that the efficacy achieved with Revlimid and Rituxan in terms of progression-free survival continued to be independent of some factors including disease stage, FLIPI score (which estimates overall survival from clinical information), bulky disease and age.
Early disease progression was linked with worse five-year survival compared with a reference group at 59.5% and 95.2% respectively. In those whose disease progressed within 24 months of treatment initiation, five-year survival rates were reported to be comparable between the groups at 59% and 60%, respectively.
No new safety signals were reported, according to the study.
A total of 15 patients experienced at least one fatal toxicity associated with treatment; nine occurred in the investigative group and six occurred in the control group. New fatal effects reported since the initial analysis of the trial were chronic obstructive pulmonary disease (one patient) and adenocarcinoma of the colon (two patients).
Moreover, those with second primary malignancies increased from 7% in 2017 to 11% in 2020 in the investigative group; these rates jumped from 10% to 13% in the control group. The number of deaths increased from 66 in 2017 to 114 in 2020.
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