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Lutetium-177 PSMA-617 Demonstrates Efficacy in Metastatic Castration-Resistant Prostate Cancer

  • Lutetium-177 PSMA-617 (LuPSMA) significantly improved radiographic progression-free survival compared to changing androgen receptor pathway inhibitors (ARPI) in taxane-naive mCRPC patients.
  • A confirmed prostate-specific antigen (PSA) response was observed in 51% of patients treated with LuPSMA, versus only 17% in the ARPI change group.
  • Expanded access program data shows LuPSMA provides similar overall survival and PSA response rates to VISION trial, even in later-stage mCRPC patients.
  • LuPSMA exhibits a favorable safety profile with a lower incidence of grade 3 or higher adverse events compared to ARPI, despite longer treatment exposure.

177Lu-PSMA-617 Managed Access Program for mCRPC Patients

NCT04825652No Longer Available
Advanced Accelerator Applications

Xspray Pharma Plans Dasynoc NDA Resubmission After Positive FDA Meeting

  • Xspray Pharma plans to resubmit its New Drug Application (NDA) for Dasynoc in Q4 2024, following constructive feedback from the FDA.
  • The FDA recommended minor adjustments to Dasynoc's tablet strengths to mitigate medication errors, with new batches already in production.
  • Dasynoc's pH-independent formulation addresses absorption challenges in cancer patients using pH-altering medications, ensuring consistent treatment.
  • If the FDA grants a two-month review, Dasynoc's launch could occur as early as Q1 2025, offering a more reliable treatment option.

HR070803 Plus 5-FU and Leucovorin Extends Survival in Advanced Pancreatic Cancer

  • HR070803 combined with 5-FU and leucovorin significantly extended overall survival in patients with unresectable locally advanced or metastatic pancreatic cancer after gemcitabine failure.
  • The HR070803 group showed a 37% reduction in the risk of death and a median overall survival extension of 2.4 months compared to the placebo group.
  • The combination therapy demonstrated a manageable safety profile, with adverse events consistent with those known for irinotecan, and no new toxicities observed.
  • HR070803 plus 5-FU and leucovorin might be a promising alternative in regions where Onivyde is not readily available, offering a comparable efficacy.

Trastuzumab Biosimilar Plus Pertuzumab Shows Efficacy in HER2-Positive Breast Cancer

• A study in the Asian Journal of Surgery found that a trastuzumab biosimilar combined with pertuzumab and chemotherapy is effective for HER2-positive breast cancer. • The real-world study reported a total pathological complete response rate of 68.2% and a breast pathological complete response rate of 81.8%. • The combination therapy demonstrated a 100% objective response rate and disease control rate, indicating high efficacy in the studied cohort. • The treatment offers a safe and potentially more affordable alternative to originator trastuzumab for neoadjuvant therapy.

Carematrix Launches Blinded Remote Monitoring Tech for Clinical Trials

  • Carematrix has released a blinded blood pressure monitor and scale for remote patient monitoring in clinical trials, ensuring data integrity.
  • The devices prevent study participants from viewing their data, reducing the risk of subconscious behavioral changes that could skew trial results.
  • The remote monitoring equipment allows investigators to respond to health emergencies without unblinding the study, maintaining data accuracy.
  • By automating data collection and upload, the new technology minimizes human errors and potential biases in clinical trial data management.

Nura Bio Secures $140 Million to Advance Neuroprotective Drug NB-4746 Targeting SARM1

  • Nura Bio closed a $140 million Series A financing round to advance its neuroprotective small molecule therapies for neurological diseases.
  • The funding will support a Phase 1b/2 study of NB-4746, a SARM1 inhibitor, planned for 2025 following positive Phase 1 safety data.
  • NB-4746 has demonstrated potential in preclinical studies to prevent axon degeneration, a key feature of various neurological disorders.
  • Shilpa Sambashivan, a founding member and former CSO, has been appointed as CEO to lead Nura Bio through its next phase of clinical development.

Lecanemab Approved in UK Amidst NICE Hesitation Over Efficacy and Cost

  • The UK MHRA has approved lecanemab for early-stage Alzheimer's patients with limited APOE4 gene copies, amidst ongoing debate about its clinical and economic value.
  • NICE issued draft guidance against NHS use, citing small treatment effects, long-term uncertainties, and economic model concerns, requesting further data from Eisai.
  • The decision has sparked controversy, highlighting the conflict between high expectations for Alzheimer's treatments and the reality of modest benefits, safety risks, and high costs.
  • Experts emphasize the need to communicate the true magnitude of lecanemab's treatment effects, considering both clinical outcomes and economic implications for healthcare systems.

NUBEQA Plus ADT Demonstrates 46% Risk Reduction in Metastatic Hormone-Sensitive Prostate Cancer

  • The Phase III ARANOTE trial revealed that NUBEQA (darolutamide) combined with ADT significantly reduced the risk of progression or death by 46% in mHSPC patients.
  • NUBEQA plus ADT showed a statistically significant improvement in radiological progression-free survival (rPFS) compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001).
  • Bayer plans to submit the ARANOTE data to the FDA to expand NUBEQA's label for use in metastatic hormone-sensitive prostate cancer (mHSPC) treatment.
  • The safety profile of NUBEQA remained consistent with previous studies, with no new safety signals observed in the ARANOTE trial.

Elacestrant Plus Abemaciclib Shows Promise in Pretreated ER+/HER2- Metastatic Breast Cancer

  • The combination of elacestrant and abemaciclib demonstrates clinical activity in patients with ER-positive, HER2-negative metastatic breast cancer who have received prior treatments.
  • The phase 1b/2 ELECTRA trial reported an objective response rate of 26% among evaluable patients treated across three cohorts, including one complete response.
  • The combination therapy was well-tolerated, with no grade 4 adverse effects reported and neutropenia primarily attributed to abemaciclib's known safety profile.
  • The recommended phase 2 dose was determined to be 345 mg of elacestrant daily plus 150 mg of abemaciclib twice daily, based on safety and efficacy data.

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

NCT03778931CompletedPhase 3
Stemline Therapeutics, Inc.
Posted 5/10/2019

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

NCT05563220RecruitingPhase 1
Stemline Therapeutics, Inc.
Posted 1/24/2023

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer

NCT05386108RecruitingPhase 1
Stemline Therapeutics, Inc.
Posted 8/31/2022

Low-Dose Aspirin Evaluated for Gastric Cancer Prevention in High-Risk Iranian Population

  • A phase III randomized controlled trial is underway in Iran to assess the effectiveness of long-term, low-dose aspirin in preventing gastric cancer.
  • The study aims to enroll 21,000 participants aged 35-70 in Ardabil, a region with a high incidence of gastric cancer and H. pylori prevalence.
  • Participants will receive either 81 mg of enteric-coated aspirin or a placebo daily for 10 years, with outcomes measured 5 years after treatment.
  • The primary outcome is the difference in the cumulative incidence rate of gastric cancer between the aspirin and placebo groups.

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