At the American Society of Hematology (ASH) Annual Meeting on 7 December, Galapagos NV unveiled new data of its Phase II Atalanta-1 trial for the novel seven-day “vein-to-vein” CD19 chimeric antigen receptor (CAR) T-cell therapy GLPG5101. The trial took place across a basket of relapsed or refractory (r/r) B-cell lymphoma indications, diffuse large B-cell lymphoma (DLBCL), indolent non-Hodgkin lymphoma (iNHL), and mantle cell lymphoma (MCL). Patients in this trial received at least two prior lines of therapy. Since 2017, there have been several approvals for CD19-targeting CAR T-cell therapies in these indications such as Gilead’s Yescarta in DLBCL and iNHL, Bristol Myers Squibb’s Breyanzi in DLBCL and MCL, and Gilead’s Tecartus in MCL.
Galapagos has achieved this quick turnaround time by decentralising its manufacturing process, with four out of six Belgium and the Netherlands centres involved in the trial having the capability to produce the therapy. Out of the 45 patients who received their dose, 41 received it within seven days while another two received theirs after just eight days. A recent US Food and Drug Administration (FDA) approval of a manufacturing change for Yescarta has reduced the median turnaround time, defined as the number of days between leukapheresis, or harvesting of the patient’s T cells, and the release of the CAR T-cell product, from 14 to 16 days. The shorter vein-to-vein time of GLPG5101 has reduced the need for a cytotoxic bridging therapy and helped improve its safety profile compared to the competitors. Of the 45 patients assessed for safety on the trial, 43% had any grade cytokine release syndrome (CRS), with 2% experiencing grade 3 CRS while 20% had any grade neurotoxicity, with 2% experiencing a grade 3 neurotoxic event.
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Positive efficacy results for GLPG5101 in the Atalanta-1 trial were also presented. Complete response (CR) was seen in 54% of DLBCL patients (although 71% of DLBCL patients who received a higher dose achieved CR), 95% of iNHL patients, and 100% of MCL patients; 80% of patients who achieved CR were also assessed to be negative for minimal residual disease, and none of these patients had relapsed with a median of 12 months between dosage and assessment. In comparison, Yescarta and Breyanzi achieved a CR rate of 65% and 53%, respectively, in r/r DLBCL. Tecartus and Breyanzi reached a CR rate of just 62% and 67%, respectively, in their pivotal trials in r/r MCL. Yescarta achieved a CR rate of 60% in follicular lymphoma, the most common subtype of iNHL.
This early data has demonstrated a clear improvement in GLPG5101 efficacy over its competitors in iNHL and MCL. Galapagos has received FDA clearance to expand the Atalanta-1 trial into the US, with recruitment expected to start soon.
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