1. Scrip
  2. >>Business
  3. >>Strategy

Merck Set To Add Perioperative Head-And-Neck Cancer To Keytruda Label

 
• By Joseph Haas

With positive data versus radiation therapy in KEYNOTE-689, Merck & Co. files for approval in perioperative head and neck cancer, adding to additional claim in that cancer type.

Merck presents successful data for Keytruda in perioperative head and neck cancer (Shutterstock)

Merck & Co. presented full data from a Phase III trial testing Keytruda (pembrolizumab) as perioperative treatment in stage III or IVA resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) that may support an additional indication for the anti-PD-1 agent on top of its current US Food and Drug Administration approval for metastatic or unresectable, recurrent HNSCC.

Key Takeaways
  • Merck’s KEYNOTE-689 trial shows that perioperative Keytruda can reduce risk of event-free survival in stage III-IVA head and neck cancer compared to radiotherapy.

The data from the KEYNOTE-689 trial showing a 21.4-month greater duration of event-free survival (EFS) compared to standard of care...

More from Strategy

Ionis’s Dawnzera Becomes First RNA-Targeted HAE Prevention Drug

 
• By Joseph Haas

Dawnzera joins CSL’s recently approved Andembry as new additions to the crowded hereditary angioedema prevention market. It is priced at $57k per dose, but labeling includes four- or eight-week options.

Nicox Plots US Submission After Another Phase III Glaucoma Win

 
• By Kevin Grogan

The France-headquartered firm’s eye drop has demonstrated efficacy in a second pivotal trial.

Madrigal Regains Lead With Rezdiffra MASH Approval In EU

 
• By Joseph Haas

Four days after Wegovy became the second approved MASH therapy in the US, Rezdiffra gets the first European approval. Plans are for an initial launch in Germany.

Celldex Bullish On Barzolvolimab Despite Study Miss

 
• By Kevin Grogan

All eyes on chronic urticaria after eosinophilic esophagitis disappointment.

More from Therapy Areas

Celldex Bullish On Barzolvolimab Despite Study Miss

 
• By Kevin Grogan

All eyes on chronic urticaria after eosinophilic esophagitis disappointment.

BioNTech/BMS Bispecific Shows Early Promise In Small Cell Lung Cancer

 
• By Andrew McConaghie

An updated abstract from the World Conference on Lung Cancer has given analysts confidence in BioNTech’s VEGF-A/PD-L1 bispecific challenger

China-Originated Assets Lead Global GLP-1 Deals

 
• By Xu Hu

The total value of deals for GLP-1-associated assets so far this year is already double that of the previous two years combined, with China-originated molecules accounting for a substantial majority. Scrip takes a look at some of the key factors behind this activity.