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Regeneron (REGN)/Sanofi's Libtayo Approved for Additional Indications

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the European Commission (EC) has approved the PD-1 inhibitor, Libtayo (cemiplimab), for a couple of additional indications. 

The EC approved Libtayo for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. The patients targeted for this indication must have metastatic NSCLC or locally advanced NSCLC and not be a candidate for definitive chemoradiation.

The EC approval in advanced NSCLC was based on data from a global phase III study, which showed that Libtayo significantly reduced the risk of death by 32% and extended median overall survival (OS) by 8 months compared to chemotherapy in the overall study population, even with 74% of patients crossing over to Libtayo following disease progression on chemotherapy.

Libtayo has also been approved for the treatment of adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). BCC is a common type of skin cancer.

The EC approval for the BCC indication was based on data from the largest prospective clinical trial in patients with advanced BCC previously treated with an HHI to date.  Results from the study showed that Libtayo-treated patients with locally advanced BCC experienced an objective response rate (ORR) of 32% by independent central review.

The drug was already approved by the EC as the first treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. With these new approvals, Libtayo is now approved for three advanced cancers in the European Union.

The drug was also approved for these two indications in the United States. Libtayo recorded sales of $100.8 million in the first quarter of 2021. Approval in additional geographies for additional indications will boost results.

While the indications have significant market potential, competition is stiff in particular in the NSCLC space from the likes of Merck’s (MRK - Free Report) Keytruda, among others.

Earlier, in March, Regeneron and Sanofi announced positive results from the phase III study on Libtayo in cervical cancer, which was stopped early based on a recommendation by the Independent Data Monitoring Committee (IDMC). The results demonstrated an overall survival benefit compared to chemotherapy. Regulatory submissions are planned for later this year.

Regeneron is looking to build a portfolio in the oncology space and diversify its revenue base.

The company's shares have gained 13% in the year so far against the industry’s decline of 0.4%.


Zacks Investment ResearchImage Source: Zacks Investment Research

Regeneron’s first-quarter results were strong with broad-based growth. Demand for lead drug, Eylea, in collaboration with Bayer (BAYRY - Free Report) , revived. Dupixent maintained its strong performance. Incremental contribution from REGEN-COV boosted the top line and should propel sales as the pandemic continues.

Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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