Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the European Commission approved odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
The drug has been approved under the brand name Ordspono.
The approval is based on results from the phase I ELM-1 and pivotal phase II ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL.
Regeneron's shares have rallied 37.3% year to date against the industry's decline of 0.2%.
Image Source: Zacks Investment Research
Positive Study Results Help REGN
Results from ELM-2 (n=128), as assessed by an independent review committee, showed an objective response rate (ORR) of 80%, with 73% achieving a complete response in R/R FL.
Results from ELM-2 (n=127) in patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR in R/R DLBLCL.
Results from ELM-1 (n=60) in patients who had progressed after CAR-T therapy, as assessed by an IRC, showed 48% ORR, with 32% achieving a CR.
The approval in the EU is the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking ...
