Enhertu granted priority review in the U.S. for patients with HER2 low or HER2 ultralow metastatic breast cancer
- Daiichi Sankyo and AstraZeneca's sBLA for Enhertu has been accepted and granted Priority Review by the FDA.
- The application targets adult patients with unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have received at least one line of endocrine therapy.
- The Priority Review is based on data from the DESTINY-Breast06 phase 3 trial, which showed a 37% reduction in disease progression or death compared to chemotherapy.
- The FDA action date for the regulatory decision is set for February 1, 2025.
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Merus announces first patient dosed in LiGeR-HN1, a phase 3 trial evaluating petosemtamab in combination with pembrolizumab in 1L r/m HNSCC
- Merus has dosed the first patient in the phase 3 LiGeR-HN1 trial.
- The trial evaluates petosemtamab in combination with pembrolizumab versus pembrolizumab alone in 1L PD-L1+ r/m HNSCC patients.
- Primary endpoints include overall response rate and overall survival, with secondary endpoints being duration of response and progression-free survival.
- Approximately 500 patients will be enrolled in the trial.
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Primary endpoint met in phase 3 comparative clinical study of Perjeta biosimilar candidate HLX11
- Shanghai Henlius Biotech and Organon announced that the phase 3 trial for the Perjeta biosimilar HLX11 met its primary endpoint.
- The study compared HLX11 with reference Perjeta as a neoadjuvant therapy in HER2-positive, HR-negative early or locally advanced breast cancer.
- Patients were randomized 1:1 to receive either HLX11 or reference Perjeta in combination with trastuzumab and docetaxel.
- The primary endpoint was the total pathological complete response (tpCR) rate, which was successfully met.
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CLINUVEL files Canadian new drug submission for SCENESSE in EPP
- CLINUVEL has submitted a New Drug Submission (NDS) to Health Canada for SCENESSE (afamelanotide) to prevent phototoxicity in adult EPP patients.
- If approved, SCENESSE would be the first treatment available for EPP patients in Canada.
- The Health Products and Food Branch (HPFB) of Health Canada may complete the review within 300 days.
- SCENESSE is already available under Canada’s Special Access Program (SAP), with two accredited treatment centers and more identified for future use.
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Santhera announces positive topline results from LIONHEART study with vamorolone
- Santhera Pharmaceuticals announced positive results from the LIONHEART study, confirming vamorolone’s unique action as a mineralocorticoid receptor antagonist.
- The study involved 30 healthy adult male subjects and met its primary endpoint, showing a significant increase in the urinary sodium/potassium ratio in the vamorolone arm compared to placebo.
- These findings differentiate vamorolone’s pharmacological profile from other corticosteroids, highlighting its potential cardioprotective benefits in Duchenne muscular dystrophy (DMD).
- Further analysis of the data is ongoing and will be presented at medical conferences.
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KalVista submits additional marketing authorization applications for sebetralstat
- KalVista Pharmaceuticals has submitted Marketing Authorization Applications (MAAs) for sebetralstat in the UK, Switzerland, Australia, and Singapore.
- The submissions are part of the Access Consortium framework, which aims to streamline regulatory collaboration and review processes.
- Sebetralstat is an investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE) in patients aged 12 and older.
- The MAAs are supported by data from the KONFIDENT phase 3 trial, which showed significant symptom relief and a favorable safety profile.
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Precision BioSciences submits first clinical trial applications for PBGENE-HBV
- Precision BioSciences has submitted Clinical Trial Applications (CTA) to initiate a Phase 1 study for PBGENE-HBV.
- PBGENE-HBV aims to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes.
- The regulatory submissions are supported by robust non-human primate safety studies and efficacy in preclinical models.
- The company plans to initiate the Phase 1 study soon and expects to report data in 2025.
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Repare Therapeutics announces phase 1 data highlighting camonsertib in combination with radiotherapy treatment presented at the ASTRO annual meeting
- Repare Therapeutics presented Phase 1 data on camonsertib combined with palliative radiation at the ASTRO annual meeting.
- The trial involved 17 patients with metastatic tumors harboring ATM mutations.
- The recommended Phase 2 dose for camonsertib was determined to be 160 mg once-daily prior to radiation.
- Interim results showed promising response rates, with 2 complete responses and 5 partial responses at 2 months in the pathogenic ATM mutation group.
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AOP Health investigates a new approach targeting cancer stem cells
- AOP Orphan Pharmaceuticals GmbH (AOP Health) and Leukos Biotech have initiated the phase I clinical trial SERONCO-1.
- The trial investigates AOP208, a first-in-class drug targeting the serotonin receptor 1B on cancer stem cells.
- AOP208 is being tested in patients with solid tumors and lymphomas, with the first patient already treated.
- A second trial will focus on AOP208 in patients with acute myeloid leukemia.
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CEL-SCI selects Ergomed as CRO for FDA registration study of Multikine in head and neck cancer
- CEL-SCI renews collaboration with Ergomed Clinical Research for FDA confirmatory registration study of Multikine.
- Ergomed will provide global clinical operations support for the trial, focusing on patients with no lymph node involvement and low PD-L1 tumor expression.
- The study will enroll 212 newly diagnosed patients with locally advanced primary head and neck cancer across multiple global sites.
- Multikine has shown promising results in prior studies, with a 5-year survival rate of 73% in the target population.
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