Merck to present survival data and new research on 10 investigational or approved medicines at ESMO Congress 2024
- Merck will present data for four approved medicines and six pipeline candidates at the ESMO Congress 2024 in Barcelona, Spain.
- Key presentations include Phase 3 trials: KEYNOTE-522 in high-risk early-stage TNBC, KEYNOTE-A18 in high-risk locally advanced cervical cancer, and LEAP-012 in unresectable, non-metastatic hepatocellular carcinoma.
- Ten-year overall survival data from the Phase 3 KEYNOTE-006 trial for advanced melanoma will be showcased.
- New data on investigational candidates like patritumab deruxtecan, ifinatamab deruxtecan, and sacituzumab tirumotecan will also be presented.
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Revolutionary trial aims to transform pancreatic cancer treatment
- First patient enrolled in ExThera Medical’s OSCAR I STUDY at OU Health Stephenson Cancer Center.
- The trial is a Prospective Single-Arm Feasibility study to evaluate the safety and efficacy of the ONCObind procedure hemoperfusion filter.
- The ONCObind filter targets and removes Circulating Tumor Cells (CTCs) from the blood of patients with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC).
- OSCAR I will enroll 5 patients, focusing on Pharmacokinetics/Pharmacodynamics before expanding to additional participants.
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Cogent Biosciences completes enrollment for phase 3 PEAK trial in GIST patients
- PEAK Phase 3 trial for gastrointestinal stromal tumors (GIST) has completed enrollment with 413 patients.
- Interim futility analysis completed with no changes recommended by the Independent Data Monitoring Committee.
- Top-line results for PEAK expected by end of 2025.
- SUMMIT trial in nonadvanced systemic mastocytosis (NonAdvSM) to complete enrollment in Q1 2025, with results expected in 2H 2025.
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IPAX-1 study of TLX101 investigational glioblastoma therapy published in Neuro-Oncology Advances
- The IPAX-1 Phase I study confirms the safety and tolerability of TLX101 in combination with external beam radiation therapy (EBRT) for recurrent glioblastoma (GBM).
- The study showed a median overall survival (OS) of 13 months from treatment initiation and 23 months from initial diagnosis.
- Key findings include a 44.4% response rate at 3 months post-treatment and no radiation-based toxicity.
- The results support further investigation of TLX101 plus EBRT, including its potential as a first-line treatment.
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Avenzo Therapeutics announces clinical study collaboration with Gilead Sciences to evaluate AVZO-021 and Trodelvy in HR+/HER2- metastatic breast cancer
- Avenzo Therapeutics and Gilead Sciences have entered a clinical study collaboration and supply agreement.
- The study will evaluate the safety and efficacy of AVZO-021, a CDK2 inhibitor, in combination with Gilead’s Trodelvy.
- The combination targets hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
- The Phase 1b portion of the ongoing clinical study is set to initiate in the fourth quarter of 2024.
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NH TherAguix announces continuation of the phase II NANOBRAINMETS trial in the treatment of brain metastases
- NH TherAguix's Phase II NANOBRAINMETS trial continues after a successful futility analysis.
- The trial, managed by Dana Farber Cancer Institute, has enrolled 96 out of 134 patients.
- No serious adverse events related to AGuIX® were reported, indicating a favorable safety profile.
- Next interim analysis expected by the end of 2024 to assess clinical efficacy.
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Innovent receives fast track designation from the U.S. FDA for IBI363 as monotherapy for advanced melanoma
- Innovent Biologics announced that the FDA granted Fast Track Designation to IBI363 for treating unresectable locally advanced or metastatic melanoma.
- Phase 1/2 clinical trials are ongoing in China, the U.S., and Australia to assess IBI363's efficacy and safety.
- At the ESMO Plenary meeting, IBI363 showed promising efficacy with an ORR of 29.7% and DCR of 73.0% in melanoma patients who had previously undergone immunotherapy.
- Fast Track Designation facilitates the clinical development and review process, potentially speeding up the drug's approval.
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Exciting developments in clinical research: Axcellant's groundbreaking global study
- Axcellant, a European CRO, launches a groundbreaking clinical trial in nuclear medicine.
- The trial aims to innovate diagnostics for over 20 million patients in the US and 200 million worldwide.
- The study will be conducted at about 20 sites across the US East Coast and Midwest.
- FDA has approved the clinical development plan, and manufacturing sites will be activated in the coming months.
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Obsidian Therapeutics receives FDA RMAT designation for OBX-115 for the treatment of advanced melanoma
- The FDA granted RMAT designation to OBX-115 for treating unresectable or metastatic melanoma resistant to immune checkpoint inhibitor (ICI) therapy.
- OBX-115 is an engineered tumor-derived autologous T cell immunotherapy armored with membrane-bound IL15 (mbIL15) and regulated using acetazolamide.
- Initial Phase 1 data presented at the 2024 ASCO Annual Meeting showed a favorable safety profile and encouraging efficacy in heavily pre-treated patients.
- RMAT designation provides early and frequent interactions with the FDA, potentially leading to Accelerated Approval and Priority Review.
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Arcturus Therapeutics receives clearance of an investigational new drug application for ARCT-032 to treat cystic fibrosis
- The FDA has issued a 'Study May Proceed' notification for Arcturus Therapeutics' IND application for ARCT-032.
- ARCT-032 is an inhaled mRNA therapeutic designed to treat cystic fibrosis by expressing normal functional CFTR in the lungs.
- The Phase 2 study will evaluate the safety, tolerability, and efficacy of ARCT-032 in CF patients who do not benefit from CFTR modulator therapy.
- ARCT-032 has received Orphan Medicinal Product Designation from the EMA and Orphan Drug Designation along with Rare Pediatric Disease Designation from the FDA.
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