CHMP recommends EU approval of Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma – Roche
Roche announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). The standard second-line (2L) therapy for R/R DLBCL patients has historically been high-dose chemotherapy followed by stem cell transplant. New therapies have been recently introduced, however, not all patients can access or are eligible for these treatments. If approved, this Columvi combination could provide a much-needed, off-the-shelf treatment option. A final decision is expected from the European Commission in the near future.
Whilst 2L treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscores the urgent need for immediately available treatment options that can control the disease and improve survival. Columvi is designed to be off-the-shelf and readily available for infusion, meaning patients can avoid crucial delays in starting their next treatment.
The CHMP recommendation is based on results from the phase III STARGLO study, which were presented at the 29th European Hematology Association Congress and published in The Lancet. (see most recent citation. Data showed Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival improvement versus MabThera/Rituxan (rituximab) and GemOx, with a 41% reduction in the risk of death. Safety of the combination appeared consistent with the known safety profiles of the individual medicines.
STARGLO [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx (R-GemOx) in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (OS; primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.
In the primary analysis (conducted after a median follow-up of 11.3 months) patients treated with Columvi plus GemOx lived significantly longer, with a 41% reduction in the risk of death (hazard ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011) versus R-GemOx. Median OS was not reached with the Columvi regimen versus nine months for R-GemOx. Safety of the combination appeared consistent with the known safety profiles of the individual medicines. Adverse event (AE) rates were higher with the Columvi combination versus R-GemOx, noting higher median number of cycles received with the Columvi combination (11 versus 4). One of the most common AEs was cytokine release syndrome, which was generally low grade (Any Grade: 44.2%, Grade 1: 31.4%, Grade 2: 10.5%, Grade 3: 2.3%) and occurred primarily in Cycle 1.
“For patients with DLBCL who relapse after initial therapy, urgent and effective treatment is required to regain disease control,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “As the first bispecific antibody to show improved survival in DLBCL in a randomised phase III study, Columvi could offer an additional treatment option that is immediately available for patients who relapse.”
See citation- Abramson J et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet 2024; 404: 1940
