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 (darolutamide) 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 the new immuno-oncology drug is safe and signals 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.
- 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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FDA issues draft guidance on conducting multiregional clinical trials in oncology
- The FDA has released a draft guidance for conducting multiregional clinical trials (MRCT) in oncology.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- Comments on the draft guidance must be submitted within 60 days after publication in the Federal Register.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.
- Cabozantinib showed significant improvement in progression-free survival (PFS) in both pNET and epNET cohorts.
- In the pNET cohort, median PFS was 13.8 months for cabozantinib vs. 4.4 months for placebo.
- In the epNET cohort, median PFS was 8.4 months for cabozantinib vs. 3.9 months for placebo.
- The trial's positive results led to an sNDA submission to the FDA, with a target action date of April 3, 2025.
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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 outcomes between patients with and without extrahepatic disease or based on prior therapy.
- 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 (MRD) in cancer patients.
- TRACERx study analyzed over 400 NSCLC patients, showing strong detection rates for residual lung cancer.
- VHIO study on over 200 late-stage cancer patients on immunotherapy showed longer survival with significant ctDNA decrease.
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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 newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and low PD-L1 tumor expression.
- The new data showed a 5-year overall survival of 82.6% for low-risk patients treated with Multikine vs. 47.3% for those treated with standard care alone.
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IMFINZI plus IMJUDO shows unprecedented survival in advanced liver cancer
- HIMALAYA Phase III trial results show IMFINZI plus IMJUDO significantly improves overall survival in advanced liver cancer.
- At five years, 19.6% of patients treated with the STRIDE regimen were alive compared to 9.4% with sorafenib.
- The STRIDE regimen reduced the risk of death by 24% compared to sorafenib.
- The safety profile of the STRIDE regimen was consistent with known profiles, with no new safety signals observed.
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WestGene Biopharma präsentiert bahnbrechende mRNA-Impfstoffdaten auf dem ESMO 2024
- WestGene Biopharma stellte auf dem ESMO 2024 die neuesten klinischen Daten fĂĽr seinen EBV-positiven Tumor-mRNA-Impfstoff, WGc-043, vor.
- WGc-043 zeigte außergewöhnliche Sicherheit, Immunogenität und Anti-Tumor-Aktivität in klinischen Studien.
- Der Impfstoff aktiviert das Immunsystem zur Produktion von zytotoxischen T-Zellen, antigenspezifischen Antikörpern und Gedächtnis-T-Zellen.
- Die firmeneigene mRNA-Plattform von WestGene umfasst neuartige Lipid-Nanopartikel-Verabreichungssysteme und skalierbare Herstellungsprozesse.
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Patritumab deruxtecan shows significant improvement in progression-free survival in phase 3 trial for EGFR-mutated NSCLC
- HERTHENA-Lung02 phase 3 trial met its primary endpoint of progression-free survival (PFS) in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
- Patritumab deruxtecan demonstrated statistically significant improvement in PFS compared to platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy.
- Overall survival (OS) data were immature at the time of analysis; the trial will continue to assess OS as a secondary endpoint.
- The safety profile was consistent with previous trials, with most interstitial lung disease (ILD) events being low grade.
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