1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Sanofi/Regeneron Ready To Forge Ahead With Libtayo Filings In NSCLC

 
• By Mary Jo Laffler

Cemiplimab was a latecomer to the PD-1/L1 class, but a Phase III success in lung cancer will bring it to the main stage for immuno-oncology.

Silhouette of businessman holding a flag on top mountain, sky and sun light background. Vintage filter. Business, success, leadership, achievement and goal concept.
Success for Libtayo in lung cancere • Source: Shutterstock

Sanofi and Regeneron Pharmaceuticals Inc. are gearing up to submit their PD-1 inhibitor Libtayo (cemiplimab) in first-line locally advanced or metastatic non-small cell lung cancer (NSCLC), a new, larger indication that would take the drug into the more competitive immuno-oncology market.

The companies announced on 27 April that a Phase III trial in high PD-L1 expressers met the primary endpoint of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Schrödinger Drops CDC7 Inhibitor SGR-2921 After Two Patient Deaths

 
• By Alaric DeArment

The drug is one of multiple candidates in the class that have been pulled from development, though it is not the company’s lead candidate.

Vedanta’s Live Bacteria Reach A Dead End In Ulcerative Colitis

 
• By Andrew McConaghie

The microbiome-based company’s trial of VE202 in ulcerative colitis has failed in Phase II, but its ongoing Phase III study in C difficile infection is more promising.

Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 
• By Andrew McConaghie

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

Another Day Another Win For Novartis’s Ianalumab – This Time In ITP

 
• By Aakash Babu

The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.

More from R&D

Another Day Another Win For Novartis’s Ianalumab – This Time In ITP

 
• By Aakash Babu

The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.

Pfizer/Astellas’s Padcev Scores First Big Win In Bladder Cancer Study

 
• By Alaric DeArment

The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.

IO Biotech Plans Cylembio Filing Despite ‘Narrowly Missed’ Phase III Endpoint

 
• By Mandy Jackson

The company plans to meet with the US FDA prior to submitting a BLA before the end of 2025 for its cancer vaccine as a first-line advanced melanoma treatment in combination with Keytruda.