Game-changing Australian trial reshapes outcomes for lymphoma patients

Results from an Australian clinical trial is reshaping expectations for patients diagnosed with high-risk lymphoma, a cohort for whom standard chemotherapy offers less than a 50% chance of cure.

Previous large B-cell lymphoma studies of adding novel drugs to conventional chemotherapy often increased toxicity and reduced chemotherapy delivery intensity without improving outcomes.

The phase 2 COALITION trial, led by the Peter MacCallum Cancer Centre and conducted across 15 Australian sites, has delivered results that challenge the long-standing limits of conventional chemotherapy. Patients aged 18 to 65, flagged as high risk based on clinical or genetic indicators, received one of two standard chemotherapy regimens – R-CHOP or Pola-R-CHP* – combined with Roche’s CD20xCD3 bispecific antibody, Columvi (glofitamab).

“This trial involved a group of patients in whom poor outcomes are common with only half expected to be cured by conventional treatments,” said haematologist Dr Adrian Minson, who co-led the national trial with Professor Michael Dickinson, haematologist and Lead of Aggressive Lymphoma at Peter Mac.

“However, when glofitamab was added to these commonly used R-CHOP and Pola-R-CHP treatment regimes, we saw potent and durable responses in almost all patients.”

Results from the trial revealed a 98% complete response rate. At a median follow-up of 20.7 months, two-year progression-free survival (PFS) and overall survival (OS) were estimated at 86% and 92% respectively. Importantly, no new major safety issues were identified, and side effects were considered manageable.

Currently, Columvi, holds a provisional TGA approval for use with Roche’s Gazyva (obinutuzumab) in relapsed or refractory diffuse large B-cell lymphoma after two or more prior lines of therapy. The treatment is scheduled for reimbursement evaluation by the PBAC at its July meeting.

Yet, Professor Dickinson highlighted its use earlier in the treatment paradigm, saying “The COALITION trial results are exciting and support an ongoing larger Phase 3 clinical trial to assess glofitamab as a first-line treatment, in combination with other therapies, for high-risk forms of large B-cell lymphoma.”

*R-CHOP is a common chemotherapy-based treatment that includes five drugs: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Pola-R-CHP is similar but swaps vincristine for polatuzumab vedotin.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.