Novartis' SOLAR-1 Study Shines on Alpelisib In Breast Cancer

The selective PI3K inhibitor, alpelisib, met its primary PFS endpoint in top-line data from the SOLAR-1 study, but further details are needed from the trial in order to judge the drug's likely penetration of the HR-positive, HER2-negative breast cancer population.  

Blue sky
• Source: Shutterstock

Novartis AG's PI3K inhibitor, alpelisib (BYL719), has met the primary endpoint in the global Phase III SOLAR-1 trial, showing an improvement in progression-free survival (PFS) in patients with PIK3CA-mutated HR+/HER2- breast cancer.

The Basel, Switzerland-based multinational says the results will lead to the start of discussions on marketing

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

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By 

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor For IPF

 

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from R&D

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By 

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.