EU approves Regeneron’s bispecific antibody following US rejection

With the EU approval in hand, Ordspono can now be used to treat patients with relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), which cause around 15,000 and 31,000 cases in Europe each year respectively. A high proportion of patients with these cancers relapse after receiving first line therapy, and even patients with DLBCL that have received CAR-T cell therapies​ can relapse, leaving few treatment options.

As a bispecific antibody​, Ordspono binds to two different types of target at the same time. One arm of the molecule binds to a target called CD20 on cancer cells and the other arm seeks out the target CD3, which is expressed on killer T cells. By linking the two cells together, the drug leads the killer T cells to destroy the cancer cells.

The EC’s approval follows a positive opinion on the drug from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which recommended the conditional approval of the treatment in June.

The approval was based on results from two clinical trials – a phase 1 trial and a phase 2 trial. In the phase 2 trial, the treatment showed an objective response rate (ORR) of 80% and complete response (CR) rate of 73% in patients with FL, as well as an ORR of 52% and  CR rate of 31% in patients with DLBCL who hadn’t received CAR-T therapy. In the phase 1 trial, meanwhile, Ordspono showed an ORR of 48% and CR rate of 32% in patients whose cancer had returned after receiving CAR-T therapy.

“Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases,” said George Yancopoulos, Board co-Chair, President and Chief Scientific Officer of Regeneron, in a public release​.

“Physicians, especially in the community setting, will have an off-the-shelf option that can be administered out-patient – offering the chance for complete remission,” added trial investigator Stefano Luminari, who is professor of oncology at the University of Modena and Reggio Emilia, Italy.

The EU approval comes as a welcome development for the company as the US Food and Drug Administration (FDA) rejected the approval of Ordspono for the same indications in March this year​. The decision was related to Regeneron’s planned phase 3 trials, which are enrolling for their dose-finding sections, whereas the FDA indicated that the “confirmatory portions of these trials should be underway and that the timelines to completion be agreed prior to resubmission,” said the company in a public statement.

Regeneron is now working to take Ordspono to earlier lines of treatment in FL and DLBCL and in other types of blood cancer. The company is also researching the potential of a combination of Ordspono, a second experimental bispecific antibody, and the company’s checkpoint inhibitor cemiplimab (marketed as Libtayo).

Ordspono isn’t the only candidate from Regeneron to encounter a hiccup in navigating the regulatory environment. The company’s candidate linvoseltamab saw a delay to its FDA approval process last week​ as the regulator found issues with a third-party manufacturer related to a candidate from another company. However, the manufacturer is also involved with the production of linvoseltamab and is awaiting another FDA inspection.