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Sanofi: Phase 3 trial of Libtayo (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survival

Sanofi: Phase 3 trial of Libtayo (cemiplimab) monotherapy in advanced cervical cancer stopped early for positive result on overall survival
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Phase 3 Trial of Libtayo® (cemiplimab) Monotherapy in Advanced Cervical Cancer Stopped Early for Positive Result on Overall Survival

Phase 3 Trial of Libtayo® (cemiplimab) Monotherapy in Advanced Cervical Cancer Stopped Early for Positive Result on Overall Survival
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CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma

CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma
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FDA Approves Libtayo® as Monotherapy for Advanced NSCLC

FDA Approves Libtayo® as Monotherapy for Advanced NSCLC
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Subject: FDA Approves Libtayo

Regeneron and Sanofi received U.S. FDA approval for Libtayo® (cemiplimab-rwlc, an PD-1 inhibitor) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), %), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

This NSCLC indication is the third FDA approval for LIBTAYO and follows another approval earlier this month for patients with advanced basal cell carcinoma previously treated with a hedgehog inhibitor (HHI) or for whom a HHI is not appropriate. ....

Naiyer Rizvi , Peterc Adamson , Georged Yancopoulos , Ahmet Sezer , Columbia University Irving Medical Center , Teva Pharmaceutical Industries Ltd , Libtayo Development Program , Virtual Congress , Global Development Head , Regeneron Pharmaceuticals , Regeneron Pharmaceuticals Inc , Regeneron Genetics Center , European Commission , Drug Administration , Clinical Sciences , Department Of Medical Oncology , Exchange Commission , Program Milestones , European Medicines Agency , European Society For Medical Oncology , Price Family Professor , Thoracic Oncology , Priority Review , Medical Oncology , Blinded Independent Central Review , Israel Lowy ,

Sanofi: FDA approves Libtayo (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of =50%

Sanofi: FDA approves Libtayo (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of =50%
N=356
a
14 months
Median (95% CI)
b Based on stratified proportional hazards model
An additional prespecified analysis was performed in 563 patients with proven PD-L1 expression of =50%, according to the FDA-approved assay, and is described in the updated labeling of the FDA-approved assay (and also recently
published (https://www.sanofi.com/en/media-room/press-releases/2021/2021-02-12-07-00-00) in
The Lancet). This analysis showed that Libtayo reduced the risk of death by 43% compared to chemotherapy, with additional efficacy results as follows:
Endpoints ....

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