Regeneron has reported positive results with its REGN1979 drug in patients with non-Hodgkin’s lymphoma, including the evidence it can work in patients who have previously tried CAR-T therapies.
The new data for the highly-touted bispecific antibody – which targets both CD20 and CD3 – was presented at the European Haematology Association (EHA) congress in Amsterdam and showed very high response rates in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).
Overall, REGN1979 achieved a response in 13 of 14 FL patients (93%), with 10 of them (71%) having a complete response. Regeneron also reported a 57% overall response rate in DLBCL – four out of seven patients – which were all complete responses.
There were two responses among four patients who were treated with the bispecific drug after having progressed despite therapy with CAR-T for DLBCL.
At the moment, Novartis’ Kymriah (tisagenlecleucel) and Gilead/Kite’s Yescarta (axicabtagene ciloleucel) are the CAR-Ts that have been approved to treat DLBCL, with pivotal trials showing that they can achieve a response in around 50% of patients. That still leaves a large proportion of non-responders and patients who go on to relapse who could benefit from having another treatment option.
“In this trial, two patients who failed CAR-T therapy and received REGN1979 … achieved complete responses; there is currently no approved therapy for patients who progress on CAR-Ts,” commented Israel Lowy, Regeneron’s head of clinical and translational sciences.
The biotech is now moving ahead with a phase 2 programme that could potentially support regulatory filings for REGN1979 and will get underway this month in indolent and aggressive NHL types.
Meanwhile, Regeneron wants to develop REGN1979 for first-line use in these forms of lymphoma as well, positioning the drug as an alternative to CAR-T which can have serious side effects and can take some time to implement given the complexity of the cell-based treatment procedure.
REGN1979 is in a race to market with a rival CD20/CD3 bispecific antibody being developed by Roche.
Roche’s mosunetuzumab candidate showed activity in relapsed/refractory B-cell indolent and aggressive NHL in a phase 1/2 trial reported at the American Society of Haematology (ASH) meeting last December, with a 69% overall response /39% complete response rate in FL, although the numbers looked less impressive in DLBCL with rates of 34% and 19%, respectively.