FDA issues draft guidance on conducting multiregional clinical trials in oncology
- The FDA has released a draft guidance for conducting multiregional clinical trials (MRCT) in oncology.
- The guidance aims to ensure that MRCT data is applicable to U.S. patients and aligns with U.S. oncological care standards.
- There is a concern about the decreasing proportion of U.S. participants in oncology MRCTs, which may affect data interpretation.
- Comments on the draft guidance must be submitted within 60 days after publication in the Federal Register.
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Exelixis announces final results from phase 3 pivotal CABINET study evaluating cabozantinib in advanced neuroendocrine tumors
- Final data from the CABINET phase 3 trial presented at ESMO 2024 and published in NEJM.
- Study evaluated cabozantinib vs. placebo in patients with advanced pancreatic (pNET) and extra-pancreatic neuroendocrine tumors (epNET).
- Cabozantinib showed significant improvement in progression-free survival (PFS) in both pNET and epNET cohorts.
- The trial was stopped early due to dramatic PFS improvement; patients on placebo were allowed to switch to cabozantinib.
- Results supported Exelixis' supplemental new drug application (sNDA) for cabozantinib, with an FDA action date set for April 3, 2025.
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Coya Therapeutics announces anti-inflammatory effect of COYA 302 in preclinical Parkinson’s model
- Coya Therapeutics reported that subcutaneously administered COYA 302 showed direct anti-inflammatory effects in a preclinical mouse model of Parkinson’s Disease (PD).
- COYA 302 significantly reduced inflammation and microglial activation in brain regions responsible for motor control.
- The treatment also resulted in reductions in astrocyte numbers and their activation, which are known to contribute to neurodegeneration in PD.
- The promising results warrant further clinical translation into additional preclinical models and, ultimately, into patients.
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Autobahn Therapeutics initiates AMPLIFY Phase 2 trial of ABX-002 for major depressive disorder
- Autobahn Therapeutics has started the AMPLIFY Phase 2 trial to evaluate ABX-002 as an adjunctive treatment for major depressive disorder (MDD).
- ABX-002 is a selective thyroid hormone beta receptor (TRβ) agonist designed to enhance CNS benefits and drug concentrations in the brain.
- The trial is placebo-controlled, double-blind, and involves 230 adults with moderate-to-severe depression.
- Primary endpoint: change from baseline on the Hamilton Depression Rating Scale-17 (HAMD-17) after six weeks of treatment.
- Topline data from the trial is expected in the second half of 2025, with a second Phase 2 trial for bipolar disorder depression planned by yearend 2024.
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Ferrer advances research into progressive supranuclear palsy with phase II clinical trial
- Ferrer has dosed the first participant in the Phase II PROSPER clinical trial for Progressive Supranuclear Palsy (PSP).
- The trial will evaluate the safety and efficacy of FNP-223, a novel therapy aimed at slowing PSP progression.
- PROSPER is a randomized, double-blind, placebo-controlled trial with a 52-week treatment period and a 4-week follow-up.
- The study will include up to 220 participants across 46 sites in the US, UK, and 7 EU countries.
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Phase III ARANOTE trial shows NUBEQA significantly reduced risk of radiological progression or death in metastatic hormone-sensitive prostate cancer
- The Phase III ARANOTE trial demonstrated that NUBEQA plus ADT significantly improved radiological progression-free survival (rPFS) compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
- The trial involved 669 patients randomized 2:1 to receive either 600 mg of NUBEQA or placebo twice daily in addition to ADT.
- Results showed a 40% risk reduction in high-volume mHSPC and a 70% risk reduction in low-volume disease.
- Bayer plans to submit the ARANOTE trial data to the FDA to support the expanded use of NUBEQA in mHSPC patients.
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Data from a phase 1 trial of HighField Biopharmaceuticals’ HF1K16 show safety and efficacy in treating refractory metastatic cancers
- HighField Biopharmaceuticals presented positive safety and efficacy findings from a Phase 1 trial of HF1K16 at the ESMO Congress.
- HF1K16 is an ATRA-encapsulated immune modulating liposome targeting myeloid-derived suppressor cells (MDSCs).
- The Phase 1 dose escalation study showed significant immune modulation and efficacy signals, with a median overall survival of 629 days for Grade II and III gliomas and 315 days for Grade IV gliomas.
- The next step involves determining the most beneficial indication for a Phase 2 study, either as a single agent or in combination with other treatments.
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Delcath Systems presents new data on HEPZATO KIT in metastatic uveal melanoma at ESMO 2024
- Delcath Systems presented new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT at ESMO 2024.
- The trial evaluated the efficacy and safety of HEPZATO KIT in patients with unresectable hepatic metastases from metastatic uveal melanoma (mUM).
- Subgroup analysis showed no significant differences in overall survival (OS), objective response rate (ORR), or progression-free survival (PFS) between patients with and without extrahepatic disease.
- Objective tumor responses were observed throughout the treatment period, supporting continued treatment until the best response is achieved.
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ESMO 2024 data expands on compelling performance of Personalis NeXT Personal MRD test
- Personalis presented findings at ESMO Congress 2024 in Barcelona, Spain.
- NeXT Personal assay detects and monitors residual and recurrent disease in cancer patients.
- Study on 400 NSCLC patients showed strong detection rates for residual lung cancer within 120 days post-surgery.
- Second study on 200 late-stage cancer patients on immunotherapy showed significant survival benefits with decreased ctDNA levels.
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CEL-SCI’s Multikine increased 5-year survival rate to 82.6% in head & neck cancer patients
- CEL-SCI presented new data from its Phase 3 study of Multikine at the ESMO 2024 Congress.
- Multikine-treated patients recommended for surgery and radiotherapy had a nearly 4-year survival benefit over the control group.
- The FDA has requested a confirmatory Registration Study focusing on patients with the best survival benefit.
- The new data showed a 5-year overall survival of 82.6% for low-risk patients treated with Multikine vs. 47.3% for standard care.
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