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Clinical Trial News

EMA Committee Backs Roche's Phesgo, A Novel Subcutaneous Combination of Herceptin and Perjeta for HER2+ Breast Cancer

• The EMA's human medicines committee (CHMP) has recommended approval of Phesgo, a fixed-dose combination of trastuzumab and pertuzumab for HER2-positive breast cancer treatment.
• The subcutaneous formulation significantly reduces administration time from over two hours to just five minutes after initial loading dose, offering greater convenience and reduced clinic visits during the pandemic.
• Phesgo's approval would strengthen Roche's portfolio as it faces biosimilar competition for Herceptin, with the combination product already approved and available in the US market.

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer

NCT03493854CompletedPhase 3
Hoffmann-La Roche
Posted 6/14/2018

A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System

NCT05275010CompletedPhase 1
Hoffmann-La Roche
Posted 5/30/2022

An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

NCT04395508Approved for Marketing
Genentech, Inc.

Blincyto Approved for Consolidation Phase of B-ALL Treatment

  • The FDA has approved Blincyto (blinatumomab) for adult and pediatric patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase.
  • The approval is based on the Phase 3 E1910 trial, which demonstrated superior overall survival when Blincyto was added to multiphase consolidation chemotherapy compared to chemotherapy alone.
  • Blincyto is the first and only Bispecific T-cell Engager (BiTE®) therapy approved for consolidation treatment, regardless of measurable residual disease (MRD) status, marking its third indication.
  • The E1910 study's results showed a 58% reduction in the risk of death with the addition of Blincyto, redefining the standard of care for B-ALL patients.

FDA Authorizes Eli Lilly's Bamlanivimab for Early-Stage COVID-19 Treatment

• The FDA granted emergency use authorization (EUA) to Eli Lilly's bamlanivimab (LY-CoV555) for treating mild-to-moderate COVID-19 in adults and pediatric patients. • Bamlanivimab, a monoclonal antibody, is authorized for patients with positive SARS-CoV-2 test results who are at high risk of progressing to severe COVID-19 or hospitalization. • The drug should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, according to Eli Lilly. • Bamlanivimab is not authorized for patients hospitalized due to COVID-19, as studies suggest it may not be beneficial and could potentially worsen outcomes in these cases.

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.

Exscientia Strengthens AI Drug Discovery Leadership with AstraZeneca Veteran as New CTO

• Former AstraZeneca head of hit discovery Dr. Garry Pairaudeau joins Exscientia as Chief Technology Officer, bringing 25 years of expertise in AI, machine learning, and drug discovery.
• Pairaudeau's appointment comes as Exscientia advances its AI-driven drug discovery platform, which has already produced the first AI-designed drug molecule to enter clinical trials for OCD treatment.
• The move reflects the growing importance of AI in pharmaceutical R&D, with the global AI healthcare market projected to grow from $2.1 billion in 2018 to $36 billion by 2025.

Exploring New Frontiers in Non-Small Cell Lung Cancer Treatment

Recent discussions and studies highlight the evolving landscape of non-small cell lung cancer (NSCLC) treatment, focusing on antibody-drug conjugates (ADCs) and their potential benefits, sequencing strategies, and management of toxicities. Key trials such as EVOKE-01, HERTHENA-Lung01, and MARIPOSA are examined for their impact on patient care.

Liso-cel Plus Ibrutinib Shows Promise in Relapsed/Refractory CLL/SLL: Primary Results from TRANSCEND CLL 004 Study

  • Primary results from the phase 1/2 TRANSCEND CLL 004 study demonstrate efficacy of lisocabtagene maraleucel (liso-cel) combined with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.
  • The combination therapy showed manageable safety profile with reduced incidence of severe cytokine release syndrome compared to historical CAR-T monotherapy data in this difficult-to-treat patient population.
  • This novel approach represents a potential advancement in cellular therapy options for CLL/SLL patients who have failed previous treatment regimens, addressing a significant unmet need in hematologic oncology.

PSMA PET-CT Improves Prostate Cancer Metastasis Detection

  • PSMA PET-CT imaging proves more accurate than standard CT and bone scans in detecting prostate cancer metastasis, with 92% accuracy versus 65%.
  • The use of PSMA PET-CT led to a change in treatment plans for 28% of patients, compared to 15% with standard imaging, optimizing patient care.
  • PSMA PET-CT reduces inconclusive results (7% versus 23%), minimizing the need for additional scans and biopsies, streamlining diagnosis.
  • FDA approved Gallium (Ga) 68 PSMA-11 for PET imaging in prostate cancer, enhancing detection of spread and recurrence based on PSA levels.

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