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Photocure and Karl Storz Launch Advanced Blue Light Cystoscopy System in US Market

Oncology
  • Photocure ASA announces the commercial availability of Karl Storz's New Blue Light equipment powered by Saphira technology in the United States for bladder cancer detection.
  • The advanced system shows strong market demand with orders outpacing previous systems, signaling potential for blue light cystoscopy to become standard of care for bladder cancer visualization.
  • Bladder cancer affects 1.72 million patients globally with high recurrence rates up to 78% over five years, making improved detection technology critically important for patient outcomes.

Tagrisso Plus Savolitinib Shows Promising 49% Response Rate in EGFR-Mutated Lung Cancer with MET Resistance

Targeted TherapyOncologyPrecision Medicine
• Preliminary results from the SAVANNAH Phase II trial demonstrated that Tagrisso (osimertinib) plus savolitinib achieved a 49% objective response rate in EGFR-mutated NSCLC patients with high levels of MET overexpression who progressed on Tagrisso.
• MET was identified as the most common resistance biomarker in EGFR-mutated lung cancer, with 62% of patients screened showing MET overexpression and/or amplification after progression on Tagrisso.
• The combination therapy showed the highest response rate (52%) in patients with high MET levels who had not received prior chemotherapy, potentially offering a less toxic alternative to the current standard of chemotherapy after targeted therapy failure.

Lead Pharma and Oxeltis Secure €800K Grant to Develop First-in-Class DLBCL Therapy

OncologyDrug Discovery
  • Lead Pharma and Oxeltis received an €800K EUREKA Eurostars grant to fund their three-year EPIGENEXT project developing a first-in-class small molecule therapy for diffuse large B-cell lymphoma.
  • DLBCL affects approximately 115,000 people worldwide annually, with 30-50% of patients experiencing relapse after standard R-CHOP treatment and poor long-term survival rates.
  • The collaboration aims to address the significant unmet medical need in DLBCL treatment, where current chemotherapy approaches cause debilitating side effects and fail to cure nearly half of patients.

Cullinan Oncology and Taiho Pharmaceutical Forge $275M Strategic Collaboration for EGFR Inhibitor CLN-081/TAS6417

Targeted TherapyOncologyPrecision Medicine
  • Taiho Pharmaceutical will acquire Cullinan Pearl for $275 million upfront plus up to $130 million in regulatory milestones, gaining exclusive global rights to CLN-081/TAS6417 outside the U.S.
  • CLN-081/TAS6417 is an oral, irreversible EGFR inhibitor targeting exon 20 insertion mutations in non-small cell lung cancer, which affect approximately 2-3% of NSCLC patients globally.
  • The companies will jointly develop and co-commercialize the drug in the U.S. with equal profit sharing, while Taiho will commercialize in territories outside the U.S. and China.

HUTCHMED to Present Key Clinical Data for Multiple Cancer Therapies at ASCO 2025

Targeted TherapyOncology
  • HUTCHMED will showcase new data from several studies at the 2025 ASCO Annual Meeting, including promising results from the SACHI Phase III trial of savolitinib plus osimertinib in EGFR-mutant NSCLC with MET amplification.
  • The Phase I study of ranosidenib (HMPL-306), a dual IDH1/2 inhibitor, demonstrated favorable tolerability and 100% disease control rate in lower-grade glioma patients, showing potential for this novel targeted therapy.
  • Fruquintinib combination therapy showed clinically meaningful responses in advanced endometrial cancer patients with pMMR status, with an objective response rate of 37% in serous carcinoma subgroup and durable efficacy regardless of prior chemotherapy exposure.

Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

NCT05015608Active, Not RecruitingPhase 3
Hutchison Medipharma Limited
Posted 11/22/2021

Zanidatamab Plus Chemotherapy Shows Promising Results in Heavily Pretreated HER2-Positive Breast Cancer

Oncology
  • Zanidatamab, a novel HER2-targeted bispecific antibody, demonstrated a 36.4% objective response rate and 86.4% disease control rate when combined with chemotherapy in heavily pretreated HER2-positive breast cancer patients.
  • The combination therapy showed a median progression-free survival of 7.3 months, with 42% of patients still on treatment at data cutoff, offering new hope for patients who have progressed after multiple HER2-targeted therapies.
  • The treatment was well-tolerated with manageable side effects, primarily low-grade diarrhea, supporting further investigation as a potential new therapeutic option for advanced HER2-positive breast cancer.

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

NCT02892123CompletedPhase 1
Jazz Pharmaceuticals
Posted 9/30/2016

Lorlatinib Shows Promising Efficacy in ALK-Rearranged NSCLC with 21.8 Month Median PFS

Real World EvidenceOncologyTargeted Therapy
  • A real-world study of lorlatinib in ALK-rearranged non-small cell lung cancer demonstrated a median progression-free survival of 21.8 months, significantly higher than in previous trials.
  • The objective response rate was 43% with disease control achieved in 94% of patients, while 81% of patients with brain metastases showed objective response for intracranial lesions.
  • Patients experiencing adverse events, particularly hypercholesterolemia and edema, had significantly better outcomes than those without side effects, suggesting a potential correlation between drug exposure and efficacy.

Prestige Biopharma Partners with Teva Israel for Trastuzumab Biosimilar Commercialization

Monoclonal AntibodyOncology
  • Prestige Biopharma has entered an exclusive commercialization agreement with Teva Israel for its trastuzumab biosimilar Tuznue (HD201) targeting HER2-positive breast cancer and gastric adenocarcinoma.
  • Phase 3 TROIKA trial data demonstrated equivalent efficacy to Herceptin with 46.6% complete response rate in the biosimilar arm versus 46.2% for the reference product.
  • The European Medicines Agency is currently reviewing the marketing authorization application for Tuznue based on positive clinical trial results.
  • This partnership expands Prestige's global commercialization strategy, following previous agreements with Pharmapark for Russia and Mundipharma for multiple European markets.

FDA Approves Monjuvi in Combination with Lenalidomide for Relapsed/Refractory DLBCL

Drug ApprovalMonoclonal AntibodyOncology
  • The FDA has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide as the first second-line treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
  • The approval was based on the Phase 2 L-MIND study, which demonstrated a 55% overall response rate with a 37% complete response rate and median duration of response of 21.7 months.
  • Approximately 10,000 patients are diagnosed annually in the United States with relapsed or refractory DLBCL who are not eligible for stem cell transplant, representing a significant unmet medical need.
  • Monjuvi is a humanized CD19-targeting monoclonal antibody that received accelerated approval and will be co-commercialized by MorphoSys and Incyte in the United States.

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

Pertuzumab Regimen Shows Modest Survival Benefit in HER2-Positive Early Breast Cancer

Monoclonal AntibodyOncologyDrug ApprovalTargeted Therapy
• The APHINITY trial's 6-year analysis reveals that adjuvant pertuzumab with trastuzumab plus chemotherapy improved overall survival by 0.9% in HER2-positive early breast cancer patients, though not reaching statistical significance.
• Patients with node-positive disease showed the most significant benefit from the pertuzumab regimen, with a 4.5% absolute improvement in invasive disease-free survival at 6 years compared to placebo.
• The pertuzumab combination maintained a favorable cardiac safety profile with severe cardiac events occurring in less than 1% of patients, supporting its continued use in high-risk HER2-positive early breast cancer.
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