A/Prof Eliza Hawkes

‘Priming’ the immune system with nivolumab (N) prior to tumour-directed therapy for the first line treatment of follicular lymphoma could potentially provide an alternative to chemotherapy, with the regimen demonstrating favourable toxicity and outcomes, according to research from Australia presented at ASCO this week.

In a poster session, oncologist and lymphoma lead clinal scientist at Austin Health, Associate Professor Eliza Hawkes, said while standard of care immunochemotherapy in front-line follicular lymphoma (FL) is highly efficacious it’s not without significant toxicity. High rates of grade 3-5 adverse events (AEs), primarily infection and bone marrow suppression, are experienced in up to 75% of patients, she says.

In looking at an alternative, more tolerable approach, Associate Professor Hawkes and colleagues established 1ST FLOR. – a phase II multi centre study looking at Immune-priming with single-agent nivolumab, then combination nivolumab with rituximab as first line therapy.

While the concept of ‘priming’ the immune system has rationale and evidence, its safety in the first line FL has not been previously investigated, the teams states.

The trial, which enrolled 39 patients with stage III-IV grade 1-3A FL and an ECOG score of ≤2, investigated induction nivolumab 240mg IV 2-weekly for 4 cycles. Patients with complete response (CR) received a further four cycles of 240mg IV nivolumab monotherapy followed by 12 cycles of maintenance nivolumab 480mg IV 4-weekly.

Meanwhile patients not demonstrating CR had 240mg nivolumab plus 375mg/m2 IV rituximab 2-weekly for 4 cycles followed by maintenance nivolumab +rituximab (nivolumab 480mg 4 weekly for 12 cycles; rituximab 12 weekly for 8 cycles).

At a median follow up of 17.5 months the regimen was associated with favourable toxicity and high ORR and CR rates, conference attendees heard.

Overall response rate was 92% (36/39) with CR in 54% (21/39) and median time to CR was 5 months.

Nine pts (23%) discontinued treatment – seven due to progressive disease, two developed constitutional symptoms and one patient died of transformed FL.

In 25 evaluable patients 12-month PFS & OS is 72% (CI 51-88) and 96% (CI 80-100).

Investigators say biomarker analysis is in progress.

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