Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the European Commission (EC) has granted approval for Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) who have undergone two or more lines of systemic therapy. This marks the first global regulatory approval for Ordspono in these patient populations. Ordspono is a bispecific antibody designed to connect lymphoma cells with T cells, enabling the immune system to target and destroy the cancerous cells.
“The EC’s approval of Ordspono is a significant advancement for patients in the EU, providing a new treatment option for both indolent and aggressive lymphomas,” said Dr. Stefano Luminari, Professor of Oncology at the University of Modena and Reggio Emilia, hematologist at the Hematology Unit of Arcispedale Santa Maria Nuova in Reggio Emilia, and a trial investigator. “Ordspono demonstrated impressive complete response rates in follicular lymphoma during clinical trials, along with strong efficacy in diffuse large B-cell lymphoma, including in patients who had previously received CAR-T therapy. Physicians, particularly those in community settings, now have an accessible, off-the-shelf treatment option that can be administered in outpatient settings, offering the potential for complete remission.”
The approval was supported by data from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which showed strong and durable response rates in adults with R/R FL or R/R DLBCL:
- In R/R FL, results from the ELM-2 trial (N=128) assessed by an independent review committee (IRC) revealed an objective response rate (ORR) of 80%, with 73% of patients achieving a complete response (CR). The median duration of response (DoR) among those who achieved a complete response was 25 months (95% confidence interval [CI]: 20 months to not estimable [NE]).
- In R/R DLBCL:
- ELM-2 trial results (N=127) for patients who were CAR-T therapy naïve, assessed by IRC, showed an ORR of 52%, with 31% achieving a CR. The median DoR for complete responders was 18 months (95% CI: 10 months to NE).
- ELM-1 trial results (N=60) for patients who had relapsed after CAR-T therapy, as assessed by IRC, showed an ORR of 48%, with 32% achieving a CR. Among responders (n=29), the median DoR was 15 months (95% CI: 3 months to NE).
The most common adverse reactions included cytokine release syndrome (CRS; 54%), neutropenia (41%), fever (39%), anemia (38%), thrombocytopenia (27%), diarrhea (24%), and COVID-19 (22%). Serious adverse reactions primarily included CRS (14%), pneumonia (9%), COVID-19 (9%), and fever (6%). Ordspono carries risks of serious or fatal infections and CRS, which can be life-threatening.
“Ordspono is the first approval from our bispecific antibody platform, which we aim to expand as we develop more practice-changing medicines for oncology and other diseases,” stated George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President, and Chief Scientific Officer of Regeneron. “Following this approval, we are enthusiastic about our OLYMPIA program, which includes multiple Phase 3 trials investigating Ordspono as a monotherapy and in combination therapies across earlier lines of treatment. We are also advancing our broader pipeline of CD3 and other bispecific therapies for additional hematologic cancers such as myeloma, and exploring their potential in solid tumors.
