Novartis investigational checkpoint inhibitor tislelizumab met primary endpoint of overall survival in pivotal Phase III trial of esophageal cancer after systemic therapy

  • Tislelizumab demonstrated a 30% reduction in the risk of death and extended median overall survival by 2.3 months compared to chemotherapy in advanced or metastatic esophageal squamous cell carcinoma after prior systemic therapy1
  • Additional Phase II data presented at ASCO showed tislelizumab demonstrated durable anti-tumor activity in patients with microsatellite instability-high, or mismatch-repair-deficient, solid tumors2

Basel, June 4, 2021 — Novartis announced today results from …

/by

Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera

  • At final analysis, study showed clinically relevant improvement in median overall survival with a difference of 11.7 months between arms (Hazard ratio (HR): 0.84 with 95% CI: (0.60, 1.17) (p=0.30, two-sided))1 
  • No new safety signals emerged in long-term follow-up with median of 6.3 years; safety profile consistent with previously reported results1
  • Previously reported primary analysis demonstrated statistically significant improvement in …
/by

Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study

  • Men who received 177Lu-PSMA-617 plus best standard of care had a 38% reduction in risk of death (median OS benefit of 4 months) and a 60% reduction in the risk of radiographic disease progression or death (median rPFS benefit of 5 months) compared to best standard of care alone1
  • Significant improvement demonstrated in all key secondary endpoints, including time to first symptomatic skeletal event, overall response rate and disease control rate1
    …
/by

Novartis Kymriah® pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma

  • Primary analysis of ELARA trial demonstrated a 66% complete response rate and 86% overall response rate with one-time Kymriah infusion1

  • Robust response observed in heavily pretreated patients in critical need of a potentially definitive treatment option1,2

  • No patients in ELARA trial experienced grade 3/4 cytokine release syndrome, the most common side effect associated with CAR-T therapy1

  • Global regulatory …
/by

Novartis Kisqali® reports longest median overall survival in postmenopausal HR+/HER2- metastatic breast cancer patients

  • MONALEESA-3 median overall survival (OS) results of 53.7 months underscore that Kisqali offers more life to postmenopausal women with HR+/HER2- metastatic breast cancer (MBC) in addition to the OS benefit demonstrated for premenopausal women as shown in MONALEESA-71,2

  • The relative risk reduction of death by 36% in the MONALEESA-3 first-line (1L) postmenopausal population highlights that Kisqali is the only CDK4/6i with proven OS for 1L in combination with fulvestrant1

    …

/by

Novartis presents positive Phase III results from JUNIPERA study supporting Cosentyx® as a potential treatment in a JIA population at EULAR 2021

  • Phase III JUNIPERA study met its primary endpoint, with Cosentyx® (secukinumab) showing significantly longer time to flare (longer time to worsening of symptoms1) vs. placebo (P<.001) in pediatric patients with two subtypes of juvenile idiopathic arthritis (JIA)2

  • JIA has limited treatment options and affects approximately 2 million children worldwide3,4. Subtypes juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA …
/by

Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis

  • Approval for moderate to severe pediatric patients six years and older is based on pivotal trial data showing Cosentyx demonstrated superior improvements of skin symptoms compared to placebo1
  • The safety profile of Cosentyx in pediatric patients with plaque psoriasis was demonstrated in two Phase III trials and is consistent with the established adult psoriasis indication1
  • Plaque psoriasis is a chronic, inflammatory disease that may impact up to 350,000 children worldwide, with …
/by

Novartis Hematology: Relentless Pursuit of a Cure

Scientist in lab

Novartis is deeply committed to transforming the lives of people living with blood cancers and life-threatening blood disorders. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms, and free from disease – this is our vision for the future.

Reimagining Myeloid Disorders

Novartis – together …

/by

Novartis reports one year results of Phase III MERLIN study evaluating Beovu® every four week dosing and provides update on Beovu clinical program

  • Beovu (brolucizumab) met MERLIN’s primary endpoint of non-inferiority in change in best corrected visual acuity from baseline and superiority on anatomical secondary endpoints at year one versus aflibercept when given every four weeks following the loading phase1
  • In this study evaluating every four week dosing, Beovu was associated with higher rates of IOI including retinal vasculitis and retinal vascular occlusion versus aflibercept1
  • Patient safety is of paramount …
/by

Two Decades of Pioneering Innovation in CML and Beyond

Scientist checking samples

A Breakthrough for CML and Cancer Treatment

In May 2001 – exactly 20 years ago – Novartis received approval from the US Food and Drug Administration (FDA) for the first targeted therapy for cancer, known as a tyrosine kinase inhibitor (TKI). This was a watershed moment in drug discovery, transforming the treatment landscape for chronic …

/by