Roche’s bispecific antibody, Columvi (glofitamab) has been conditionally approved for marketing in Europe by the European Commission (EC).
In April 2023, the European Medicines Agency (EMA) recommended Columvi for EC’s approval based on positive results from the pivotal cohort in the Phase I/II trial (NCT03075696).
According to a Roche press release, conditional approval has been granted to the therapy to treat adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) that have received two or more lines of systemic therapy.
In June, Columvi was approved by the US Food and Drug Administration (FDA) for the same patient population, and a launch is expected in the US market in late 2023.
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to treat R/R DLBCL and is given for a fixed time, a maximum of 12 cycles.
The World Health Organisation (WHO) estimated 36,000 people are diagnosed with DLBCL annually in Europe. In light of DLBCL’s prevalence, GlobalData forecasts Columvi’s off-the-shelf availability and a fixed-term dosage would propel its global sales to $526m in 2029.
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Roche’s global product development head Levi Garraway said: “We are delighted that we can now offer Columvi as the first approved treatment of its kind to people in Europe.”
Pivotal cohort data from Phase I/II trial
The multicentre, open-label Phase I/II NP30179 study evaluated the safety and efficacy of escalating doses of Columvi as a monotherapy and in combination with Gazya (obinutuzumab). Data showed that 50% of patients who received Columvi had an overall response to the treatment.
Among these patients, the complete response (CR) rate was 35.2%, with 74.6% of these experiencing a dose-response at 12 months. The median duration of the complete response was not yet reached. Detailed data from a larger cohort was published in the New England Journal of Medicine in December 2022.
The commonly observed adverse events included cytokine release syndrome (CRS), neutropenia, anaemia, and thrombocytopenia, with one patient discontinuation due to CRS.
Columvi’s is also being investigated in a Phase III trial in R/R DLBCL (NCT04408638) as a combination therapy with gemcitabine and oxaliplatin.