Novartis announces new interim analysis Phase II data for iptacopan in rare kidney disease C3 glomerulopathy (C3G)

  • Data shows investigational iptacopan improved estimated glomerular filtration rate (eGFR) slope and stabilized kidney function in patients with C3G1; Phase III clinical trial to start in 2021
  • Results add to body of information on iptacopan, with previous interim analysis data from same trial showing significant reduction in proteinuria, improved plasma C3 levels, and favorable safety and tolerability profile over 12 weeks2
  • There …
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Novartis announces iptacopan met Phase II study primary endpoint in rare kidney disease IgA nephropathy (IgAN)

  • Phase II primary endpoint results for investigational iptacopan in IgAN demonstrated effective and clinically meaningful reduction of proteinuria1 – a key risk predictor in kidney disease progression2

  • Iptacopan also showed a trend toward stabilization of kidney function1; …
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Novartis announces Tabrecta® first published overall survival and updated overall response data in patients with METex14 metastatic NSCLC

  • Tabrecta® (capmatinib) showed a median overall survival (OS) of 20.8 months in treatment-naïve patients and 13.6 months in previously-treated patients in first published mature data1,2
  • Tabrecta achieved 65.6% overall response rate (ORR) in first-line and 51.6% in second-line settings in new expansion cohort analysis of additional patients1,2
  • Patient-reported outcomes on quality-of-life symptoms were also presented …
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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 …

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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 …
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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
    …
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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 …
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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

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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 …
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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 …
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