Yahoo Finance Regeneron (REGN) Gets Positive CHMP Opinion for Lymphoma Drug
Regeneron Pharmaceuticals, Inc. REGN announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has recommended approval of oncology candidate odronextamab.
The CHMP adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
A final decision from the European Commission is expected in the coming months.
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
The positive CHMP opinion is supported by results from the phase I ELM-1 and pivotal phase II ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL.
The successful development of odronextamab should boost REGN’s oncology portfolio. FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL).
Per estimates, approximately 120,000 FL and 163,000 DLBCL cases are diagnosed annually worldwide. Approximately 15,000 FL and 31,000 DLBCL cases are diagnosed each year in Europe itself.
The EMA previously granted the orphan designation to odronextamab for both FL and DLBCL.
Shares of the company have risen 19.7% year to date against the industry’s decline of 6.8%.
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However, Regeneron’s efforts to get odronextamab approved by the FDA suffered a setback. The regulatory body issued complete response letters (CRLs) for its biologics license application (BLA) for odronextamab in March 2024. The BLA is seeking the approval of the candidate in R/R FL and R/R DLBCL. Regeneron stated that the sole issue with its approvability 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 approvability issue with the clinical efficacy or safety, trial design, labeling, or manufacturing.
Regeneron 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 FDA accepted the company’s BLA seeking accelerated approval for linvoseltamab, a bispecific antibody targeting BCMA and CD3, to treat adult patients with relapsed/refractory (R/R) multiple myeloma that has progressed after at least three prior therapies. The BLA was granted priority review with a target action date of Aug 22, 2024. A regulatory application is also under review in the EU.
Earlier, REGN initiated a phase II/II study of the combination of fianlimab, an antibody to LAG-3, and Libtayo in first-line metastatic melanoma.
The successful development of these oncology drugs should be a great boost for REGN and reduce its dependence on sales of lead ophthalmology drug Eylea and profits from asthma drug Dupixent for growth.
Meanwhile, Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. The late-stage OLYMPIA development program is underway, evaluating odronextamab in earlier lines of therapy and additional B-NHLs, as well as early-stage trials with chemotherapy-free combinations.
Regeneron has a collaboration agreement with Bayer BAYRY for Eylea. The company records the 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.
Partner Sanofi SNY records global net product sales of Dupixent. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Zacks Rank
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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