SAKK 35/15: a phase 1 trial of obinutuzumab in combination with venetoclax in patients with previously untreated follicular lymphoma.

Stathis, Anastasios; Mey, Ulrich J M; Schär, Sämi; Hitz, Felicitas; Pott, Christiane; Mach, Nicolas; Krasniqi, Fatime; Novak, Urban; Schmidt, Christian; Hohloch, Karin; Kienle, Dirk Lars; Hess, Dagmar; Moccia, Alden A; Unterhalt, Michael; Eckhardt, Katrin; Hayoz, Stefanie; Forestieri, Gabriela; Rossi, Davide; Dirnhofer, Stefan; Ceriani, Luca; ... (2022). SAKK 35/15: a phase 1 trial of obinutuzumab in combination with venetoclax in patients with previously untreated follicular lymphoma. Blood advances, 6(13), pp. 3911-3920. American Society of Hematology 10.1182/bloodadvances.2021006520

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This phase I study evaluated safety, tolerability and preliminary efficacy of obinutuzumab in combination with venetoclax in patients with previously untreated grade 1-3a follicular lymphoma in need of systemic therapy. Two dose levels of venetoclax were evaluated with an expansion cohort at the recommended phase 2 dose. Twenty-five patients were enrolled. The recommended phase 2 dose was venetoclax 800mg once daily continuously for 6 cycles starting on day 2 of cycle 1 with obinutuzumab 1000mg on days 1,8,15 of cycle 1 and on day 1 of cycles 2-6, followed by obinutuzumab maintenance every 2 months for two years. Only one patient had a dose-limiting toxicity consisting of grade 4 thrombocytopenia after the first obinutuzumab infusion. Neutropenia was the most common adverse event of grade ≥3 at least possibly attributed to study treatment. Twenty-four patients were evaluable for response after cycle 6 by CT and 19 by PET/CT: overall and complete response rates were 87.5% (95% CI, 67.6-97.3%) and 25% (95% CI, 9.8-46.7%) in the CT evaluated patients and 84.2% (95% CI, 60.4-96.6%) and 68.4% (95% CI, 43.4-87.4%) respectively in the PET/CT evaluated patients. One-year progression-free survival was 77.8% (95% CI, 54.6-90.1%) and 79% (95% CI, 47.9-92.7%) for CT and PET/CT evaluable patients, respectively, while progression-free survival at 30 months was 73.2% (95% CI, 49.8%, 87.0%) as assessed by CT and 79.0% (95% CI, 47.9%, 92.7%) by PET/CT. Despite the activity observed our results do not support further development of the combination in this patient population. This trial is registered at www.clinicaltrials.gov as NCT02877550.

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