drug · antibody

LIBTAYO

updated 3mo ago

by $REGN REGENERON PHARMACEUTICALS, INC.🔗 ChEMBL

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Antibody drug with a maximum clinical stage of Approval (across all indications), with 8 approved and 25 investigational indications.

targets

Programmed cell death protein 1

all catalysts(0)

nothing on the calendar yet

Trials studying LIBTAYO

phase2Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node or Other High Risk Featuresrecruitingn=21
phase1Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinomaactive not recruitingn=36
phase2Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastomaterminatedn=40
phase2Anti-PD1-antibody and Pulsed HHI for Advanced BCCactive not recruitingn=20
phase1Cemiplimab/Peg-Interferon-α in Advanced CSCCwithdrawn

News(3)

Regeneron’s ‘aversion’ to M&A questioned as bumper Q2 builds war chest
Calls for Regeneron to step up dealmaking have intensified as the company has established an $18 billion cash pile and suffered clinical trial setbacks.
biospace · 12d ago
Regeneron immunotherapy combo comes up short in melanoma trial
A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
biopharma_dive · 2mo ago
Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook
Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.
biopharma_dive · 3mo ago

brand

LIBTAYO

trade names

Libtayo

generic

CEMIPLIMAB-RWLC

MOA

12.1 Mechanism of Action Binding of the PD-1 ligands PD-L1 and PD-L2 to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

indication

1 INDICATIONS AND USAGE LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. ( 1.1 ) for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation. ( 1.1 , 14.1 ) Basal Cell Carcinoma (BCC) for the treatment of adult patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. ( 1.2 ) Non-Small Cell Lung Cancer (NSCLC) in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. ( 1.3 ) as single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. ( 1.3 , 2.1 ) 1.1 Cutaneous Squamous Cell Carcinoma LIBTAYO is indicated for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. LIBTAYO is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence [see Clinical Studies (14.1) ] after surgery and radiation . 1.2 Basal Cell Carcinoma LIBTAYO is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC

Data sources

ClinicalTrials.gov · OpenTargets

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News(3)

Regeneron’s ‘aversion’ to M&A questioned as bumper Q2 builds war chest

Calls for Regeneron to step up dealmaking have intensified as the company has established an $18 billion cash pile and suffered clinical trial setbacks.

biospace · 12d ago

Regeneron immunotherapy combo comes up short in melanoma trial

A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…

biopharma_dive · 2mo ago

Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook

Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.

biopharma_dive · 3mo ago

LIBTAYO

🐶 often sniffed alongside

targets

all catalysts(0)

Trials studying LIBTAYO

News(3)

Report a data issue

comments(0)

LIBTAYO

🐶 often sniffed alongside

targets

all catalysts(0)

Trials studying LIBTAYO

News(3)

Report a data issue

comments(0)