SOPHIA Positions MacroGenics' Margetuximab For Role In HER2-Positive Breast Cancer

MacroGenics' BLA for full approval in the US is under way and the company already has established a manufacturing facility in preparation for a launch.

Doctor with Mammography - Image

MacroGenics Inc.'s positive Phase III SOPHIA study sets its margetuximab up for a role in treating third-line-plus HER2-positive metastatic breast cancer (mBC) with potential to expand to earlier lines and other cancers. It also bodes well for the company's antibody engineering platform.

MacroGenics reported on Feb. 6, to great fanfare, positive progression-free survival (PFS) data in SOPHIA, which tested margetuximab with chemo versus Roche's pioneering HER2 therapy Herceptin (trastuzumab) with chemo...

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

More from Clinical Trials

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
• By 

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
• By 

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

InflaRx Stock Sinks As Vilobelimab Fails Phase III Skin Trial

 
• By 

A study of the German biotech's intravenous complement factor C5a antibody for pyoderma gangrenosum was stopped for futility.

More from R&D

InflaRx Stock Sinks As Vilobelimab Fails Phase III Skin Trial

 
• By 

A study of the German biotech's intravenous complement factor C5a antibody for pyoderma gangrenosum was stopped for futility.

Angelini Advances Brain Health Ambitions With GRIN Pact

 
• By 

The Italian drugmaker gets rights to Phase III-ready asset radiprodil.

Sweden’s Hansa Slims Down Ahead of Key Readouts

 
• By 

New CEO Renée Aguiar-Lucander is marking her mark.