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PharmaMar Seeks EU Fast-Track Status for Lurbinectedin-Tecentriq Combination in Extensive-Stage SCLC

Oncology
  • PharmaMar has applied for accelerated assessment from the European Medicines Agency for lurbinectedin in combination with Roche's Tecentriq (atezolizumab) for extensive-stage small cell lung cancer.
  • The company describes the combination therapy as "practice-changing" for ES-SCLC patients, potentially offering a new treatment option for this aggressive cancer with historically poor outcomes.
  • The lurbinectedin-Tecentriq combination represents a strategic partnership between PharmaMar and Jazz Pharmaceuticals, with Roche providing the immunotherapy component.

Novartis Accelerates $23 Billion US Manufacturing Investment as CEO Warns of 'Devastating' Drug Pricing Controls

Oncology
  • Novartis CEO Vas Narasimhan warns that Trump's proposed "Most Favored Nations" drug pricing policy would be "devastating to the industry" and force companies to reassess their long-term outlook.
  • The Swiss pharmaceutical giant is accelerating a $23 billion investment in US manufacturing operations to produce all key medicines domestically within the next few years.
  • Novartis reported 11% year-on-year growth in Q2 earnings, reaching $14 billion, driven by strong performance from Kisqali, Scemblix, and Leqvio.
  • The company raised its 2025 outlook, expecting net sales growth in the high single-digit range and core operating income growth in the low-teens range.

Atossa Therapeutics Unveils SMART 2.0 Study to Reduce Interval Breast Cancer in High-Risk Women

Oncology
  • Atossa Therapeutics has proposed a pioneering Phase 3 clinical study called SMART 2.0 to investigate if oral (Z)-endoxifen can reduce interval breast cancer in high-risk women identified through advanced mammographic screening.
  • The company's low-dose (1mg) (Z)-endoxifen reduced mammographic breast density by nearly 20 percent at six months in the Phase 2 KARISMA trial, with systemic side effects not statistically different from placebo.
  • Unlike tamoxifen, which has limiting adverse effects despite its effectiveness, (Z)-endoxifen appears to offer similar or greater bone benefits with minimal endometrial proliferative effects, potentially providing a safer preventive option.

Novel BTK Inhibitor Combination Shows Promise in Primary CNS Lymphoma Trial

Targeted TherapyOncology
  • A phase II trial of orelabrutinib combined with rituximab and high-dose methotrexate achieved a 71.4% overall response rate in newly diagnosed primary central nervous system lymphoma patients.
  • The combination demonstrated favorable safety with manageable toxicity, including 25% grade 3 adverse events and no treatment-related deaths in the 28-patient study.
  • At median follow-up of 21.6 months, median progression-free survival reached 35.3 months with 1-year survival rates of 64.3% for progression-free and 96.3% for overall survival.

Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma

NCT05600660RecruitingPhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University
Posted 8/1/2022

Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

NCT05334238RecruitingPhase 3
Ruijin Hospital
Posted 12/1/2021

Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

NCT05390749RecruitingPhase 2
Peking Union Medical College Hospital
Posted 4/11/2022

Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma

NCT05021770Unknown StatusPhase 1
Huiqiang Huang
Posted 12/1/2021

Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)

NCT05549284RecruitingPhase 2
Affiliated Hospital to Academy of Military Medical Sciences
Posted 6/1/2022

A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL

NCT05036577Active, Not RecruitingPhase 1
Huashan Hospital
Posted 10/10/2021

Henlius and Sandoz Partner on Ipilimumab Biosimilar in $301 Million Deal to Expand Global Access

Oncology
  • Henlius has granted Sandoz exclusive commercialization rights for its ipilimumab biosimilar HLX13 across major markets including North America, Europe, Japan, and Australia.
  • The agreement includes a $31 million upfront payment to Henlius, with potential milestone payments bringing the total deal value to $301 million.
  • This strategic partnership aims to accelerate patient access to an important immuno-oncology therapy, leveraging Sandoz's global leadership in biosimilars and Henlius's development and manufacturing capabilities.

Integrated PK/efficacy, safety, and immunogenicity study to demonstrate similarity of JPB898, a proposed biosimilar to nivolumab, to Opdivo® in combination with Yervoy®

2023-507865-24-00RecruitingPhase 3
H e x a l AG

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

NCT06841185Not Yet RecruitingPhase 3
Shanghai Henlius Biotech
Posted 4/30/2025

Flatiron Health to Showcase AI-Powered Real-World Oncology Data Research at ISPOR 2025

Real World EvidenceAIOncologyPrecision Medicine
• Flatiron Health will present over 15 research studies at ISPOR 2025, demonstrating how machine learning and AI can transform real-world oncology data into valuable evidence for regulatory decisions.
• Key presentations include validation of ML-extracted response data from EHRs, analysis of real-world evidence acceptance by FDA and EMA, and introduction of a novel Japanese breast cancer database.
• The company's research highlights the growing importance of real-world data in complementing traditional clinical trials and informing precision medicine approaches across diverse healthcare systems.

EMBARK Trial: Testosterone Levels Recover in Most Men After Prostate Cancer Treatment Suspension

Oncology
  • Post hoc analysis of the phase 3 EMBARK trial reveals over 80% of men with high-risk biochemically recurrent prostate cancer achieved full testosterone recovery after treatment suspension at 36 weeks.
  • Median time to testosterone recovery was 8.3 months for the enzalutamide plus leuprolide acetate arm versus 5.9 months for the placebo plus leuprolide arm, with age influencing recovery rates.
  • The findings support intermittent hormone therapy approaches that may improve quality of life by allowing testosterone recovery while maintaining treatment efficacy in prostate cancer patients.

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

NCT02319837Active, Not RecruitingPhase 3
Pfizer
Posted 12/17/2014

J&J's TAR-200 Shows Promising Results in BCG-Unresponsive Bladder Cancer Trial

Oncology
• New data from Johnson & Johnson's Phase IIb SunRISe-1 trial demonstrates high response rates for TAR-200 in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer, with 82.4% achieving complete response.
• The drug-device combination, which continuously delivers gemcitabine directly to the bladder over a week, showed durable efficacy with 52.9% of responders maintaining complete response at one year and a median duration of response of 25.8 months.
• J&J has filed a New Drug Application with the FDA for TAR-200 in January 2025, which is being reviewed through the Real-Time Oncology Review program, potentially offering a new treatment option for a disease with few therapeutic advances in over 40 years.

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

NCT06211764RecruitingPhase 3
Janssen Research & Development, LLC
Posted 4/9/2024

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

NCT05714202Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 3/23/2023

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

NCT04658862Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 12/7/2020

Ankyra Therapeutics Reports Promising Phase 1 Data for Anchored IL-12 Drug Conjugate in Solid Tumors

Oncology
  • Ankyra Therapeutics presented preliminary Phase 1 data for tolododekin alfa (ANK-101), an anchored IL-12 drug conjugate, showing well-tolerated dosing up to 250 µg/mL with no dose-limiting toxicities in 15 patients with metastatic solid tumors.
  • The study demonstrated 6-fold higher local IL-12 delivery compared to systemic administration while maintaining minimal systemic exposure (<1%), addressing historical toxicity limitations that previously halted IL-12 development.
  • Initial efficacy signals included two partial responses and an 80% disease control rate, with biomarker analysis showing increased CD8+ T cell infiltration and PD-L1 expression in treated tumors.
  • The company has initiated combination therapy with cemiplimab (Libtayo) in an expansion cohort, with the first patient dosed in March 2025 for advanced cutaneous squamous cell carcinoma.

Novel AI Model PROGRxN-BCa Significantly Improves NMIBC Progression Risk Prediction

AIOncologyPrecision Medicine
  • A new artificial intelligence model, PROGRxN-BCa, trained on over 12,000 patients, outperforms current guideline-endorsed risk calculators for non-muscle invasive bladder cancer progression by approximately 10%.
  • The model effectively sub-stratifies the heterogeneous intermediate-risk NMIBC patient group into distinct risk tertiles, enabling more personalized treatment approaches based on progression probability.
  • Developed using 14 readily available clinicopathological features, PROGRxN-BCa requires no specialized biomarkers or histopathological slides, making it practical for routine clinical implementation.

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