Regeneron's Bispecific Antibody Obtains EC Nod for Lymphoma

Regeneron Pharmaceuticals, Inc. 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 the lymphoma cell to a killer T cell.

Approval in the EU was mostly expected as the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of odronextamab.

The EMA previously granted odronextamab Orphan Designation for FL and DLBCL.

REGN Suffers Setback With Odronextamab

Earlier, the company's efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued complete response letters (CRLs) for its BLA for odronextamab in March 2024. The BLA is seeking the approval of the candidate R/R FL and R/R DLBCL.

The sole issue with the approval is related to the enrollment status of the confirmatory trials.

The CRLs (one for R/R FL and one for R/R DLBCL) did not identify any issue with the clinical efficacy or safety, trial design, labeling or manufacturing.

How Will the Approval Help Regeneron?

The successful development of these oncology drugs should be a great boost for REGN. It will also reduce its dependence on sales of lead ophthalmology drug Eylea and profits from asthma drug Dupixent for growth.

The firm is looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.

The company is investigating the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the phase III OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs and early-stage trials with chemotherapy-free combinations.

A phase II study for fianlimab, an antibody to LAG-3, in combination with Libtayo for perioperative non-small cell lung cancer, was also initiated. A phase II/III study for fianlimab, in combination with Libtayo for perioperative melanoma, was also initiated.

Regulatory Setbacks Derail REGN

Last week, REGN received a CRL from the FDA for its BLA for pipeline candidate linvoseltamab.

The BLA is seeking FDA approval for linvoseltamab to treat R/R multiple myeloma that has progressed after at least three prior therapies.

Regeneron stated that the sole issue identified in the CRL is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company's product candidate. The CRL delays the potential approval of the candidate.

REGN has a collaboration agreement with Bayer BAYRY for Eylea. The company records net product sales of Eylea and Eylea HD in the United States and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with sales of Eylea outside the United States.

Regeneron has a collaboration agreement with Sanofi SNY for Dupixent. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.

Zacks Rank

Regeneron currently carries a Zacks Rank #3 (Hold).

To read this article on Zacks.com click here.