Posted: Monday, August 1, 2022
The ongoing phase II FLUORO study, the details of which were presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting (Abstract TPS7587), will evaluate the safety and efficacy of the combination therapy of the monoclonal antibodies obinutuzumab plus atezolizumab, with or without radiotherapy, in patients with follicular lymphoma who have not previously received treatment. Previous studies have indicated that standard chemoimmunotherapy regimens achieve strong response rates but are accompanied by significant toxicity.
“With the [follicular lymphoma] population predominantly older than 65 years, the 10-year median survival, and need for further therapy, efficacious treatments with low toxicity are desirable,” noted Eliza Anne Hawkes, MD, of Austin Health, Heidelberg, Australia, and colleagues.
The single-arm, PET-adapted trial will initially enroll 15 patients with untreated, grade 1 to 3A, stage II to IV follicular lymphoma. The study will expand to include an additional 31 patients if at least 5 complete responses are achieved among the first 15 participants, bringing the potential patient total to 46. At the time of data presentation, seven patients from four treatment sites have been enrolled. The primary endpoint is complete response rate; secondary endpoints are overall response rate, progression-free and overall survival, and adverse events.
Patients will receive six 21-day cycles of 1,000 mg of obinutuzumab plus 1,200 mg of atezolizumab with additional obinutuzumab administered on days 8 and 15 of the first cycle. Following the second cycle, patients will undergo interim PET-CT imaging. Patients who have not achieved a complete response by cycle 3 will receive 4 Gy of radiotherapy. Those who have achieved a complete response following induction therapy will receive a maximum of 12 8-week cycles of 1,000 mg of maintenance obinutuzumab. Patients experiencing substantial disease progression will be discharged from the study. Follow-up will continue for 2 years after treatment ends.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.