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Radium-223 Plus Enzalutamide Improves Survival in mCRPC with Bone Metastases

  • The PEACE-3 trial demonstrated that adding Radium-223 to enzalutamide significantly improved radiographic progression-free survival (rPFS) in mCRPC patients with bone metastases.
  • The combination therapy also led to a statistically significant improvement in overall survival (OS) compared to enzalutamide alone, with a manageable safety profile.
  • Time to next systemic treatment was significantly prolonged with the combination, suggesting a potential new first-line treatment option.
  • The study mandated bone-protecting agents, highlighting their importance in managing bone health in patients receiving this combination therapy.

Phase III Radium 223 mCRPC-PEACE III

NCT02194842Active, Not RecruitingPhase 3
European Organisation for Research and Treatment of Cancer - EORTC
Posted 10/1/2015

Zanidatamab Plus Chemotherapy Shows Promise in HER2+ Metastatic Colorectal Cancer

  • Zanidatamab with mFOLFOX6-2, with or without bevacizumab, demonstrated significant antitumor activity in first-line HER2-positive metastatic colorectal cancer (mCRC).
  • The confirmed overall response rate (cORR) reached 90.9% across both treatment arms, with a 100% disease control rate, indicating substantial clinical benefit.
  • The combination therapy presented a manageable safety profile, with no treatment-related deaths and no discontinuations due to treatment-related adverse events (TRAEs).
  • These findings support zanidatamab-based combinations as a potential first-line treatment option for patients with HER2-positive mCRC.

A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

NCT03929666Active, Not RecruitingPhase 2
Jazz Pharmaceuticals
Posted 8/29/2019

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers

NCT02892123CompletedPhase 1
Jazz Pharmaceuticals
Posted 9/30/2016

Semaglutide Shows Promise in Reducing Mortality in Obese Individuals Without Diabetes

  • A recent trial found that semaglutide, a GLP-1 agonist, significantly reduced mortality rates in obese or overweight individuals with cardiovascular disease but without diabetes.
  • The SELECT trial demonstrated a reduction in deaths from cardiovascular causes, non-cardiovascular causes, and even COVID-19 in participants treated with semaglutide compared to placebo.
  • Unexpectedly, the reduction in mortality occurred earlier than anticipated, raising questions about mechanisms beyond weight loss and glucose control.
  • Further analysis suggests that differences in baseline health, particularly the use of loop diuretics, may have contributed to the observed mortality differences.

Zipalertinib Shows Promise in EGFR Exon 20-Mutated NSCLC After Amivantamab Failure

  • Zipalertinib demonstrates promising efficacy in heavily pretreated NSCLC patients with EGFR exon 20 insertion mutations who progressed after amivantamab treatment.
  • In patients previously treated with amivantamab alone, zipalertinib achieved an objective response rate of 50%, including one complete response.
  • The disease control rate with zipalertinib was high across all subgroups, reaching 90% in the overall population and 88.9% in the amivantamab-only group.
  • Common treatment-related adverse events included rash (38%) and paronychia (36%), with manageable grade 3 or higher events like anemia (9%).

A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

NCT04036682Active, Not RecruitingPhase 1
Cullinan Therapeutics Inc.
Posted 10/31/2019

Pembrolizumab Fails to Improve DFS in High-Risk Endometrial Cancer, Shows Benefit in dMMR Subgroup

  • Adjuvant pembrolizumab plus chemotherapy did not improve disease-free survival (DFS) compared to chemotherapy alone in high-risk endometrial cancer patients.
  • A subgroup analysis showed a clinically meaningful DFS benefit with pembrolizumab in patients with mismatch repair deficient (dMMR) tumors.
  • The 2-year DFS rate in dMMR patients was 92% with pembrolizumab vs 80% with placebo, suggesting a potential role in this specific population.
  • Safety data revealed higher rates of grade 3 or higher adverse events with pembrolizumab, but no treatment-related deaths were reported.

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

NCT04634877Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 1/10/2021

Signatera MRD Test Predicts Overall Survival in Colorectal Cancer, GALAXY Study Shows

  • Signatera, a ctDNA-based MRD test, demonstrates its ability to predict overall survival in resectable colorectal cancer patients, marking a significant advancement in personalized medicine.
  • The GALAXY study reveals that Signatera-positive patients receiving adjuvant chemotherapy experienced a 50% reduction in the risk of death, highlighting the test's predictive value for chemotherapy benefit.
  • Signatera status is identified as the most significant predictor of recurrence, outperforming standard clinicopathologic risk factors, with a notably higher hazard ratio for both DFS and OS.
  • Sustained clearance of ctDNA, as indicated by Signatera, correlates with superior survival outcomes, underscoring its potential as a surrogate endpoint for long-term prognosis in CRC patients.

Encorafenib and Binimetinib Show Promise in Untreated BRAF-Mutant NSCLC

  • Phase 2 ENCO-BRAF study reveals encorafenib plus binimetinib demonstrates significant anti-tumor activity in treatment-naïve BRAF V600E-mutant advanced NSCLC patients.
  • The investigator-assessed overall response rate (ORR) was 65.6% in previously untreated patients, indicating a potential new first-line treatment option.
  • Median duration of response (DOR) reached 13 months, with a disease control rate (DCR) of 85.2%, suggesting sustained clinical benefit.
  • Common treatment-related adverse events included fatigue, nausea, and diarrhea, manageable through dose adjustments in most patients.

ENCOrafenib With Binimetinib in bRAF NSCLC

NCT04526782Active, Not RecruitingPhase 2
Intergroupe Francophone de Cancerologie Thoracique
Posted 1/19/2021

Dato-DXd Plus Durvalumab Shows Variable pCR Rates in High-Risk Breast Cancer Subtypes

  • The I-SPY 2.2 trial evaluated datopotamab deruxtecan (Dato-DXd) plus durvalumab in stage II/III high-risk HER2-negative breast cancer, revealing an overall pathologic complete response (pCR) rate of 50%.
  • Treatment response varied significantly across response predictive subtypes (RPS), with the HR-negative/HER2-negative/immune-negative/DRD-negative subtype showing a pCR rate of 44% compared to 16% in the control.
  • The combination's toxicity profile was consistent with prior studies, and a substantial proportion of pCRs were achieved early in treatment, potentially avoiding standard chemotherapy.
  • These findings support further investigation in randomized controlled trials, particularly focusing on immune-positive and HR-negative/DRD-negative subtypes to optimize neoadjuvant breast cancer treatment.

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

NCT01042379RecruitingPhase 2
QuantumLeap Healthcare Collaborative
Posted 3/1/2010

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

NCT03742102Active, Not RecruitingPhase 1
AstraZeneca
Posted 12/21/2018

ESMO 2024: Optimizing Post-IO Therapy in Clear Cell and Expanding Options for Non-Clear Cell RCC

  • The TiNivo-2 trial found that tivozanib plus nivolumab was not superior to tivozanib alone in patients with renal cell carcinoma (RCC) following prior immune checkpoint inhibitor therapy.
  • The LITESPARK-005 study demonstrated that belzutifan maintains a progression-free survival benefit versus everolimus in previously treated advanced clear cell RCC, but is not a new benchmark.
  • The SUNNIFORECAST trial showed encouraging overall survival and objective response rates with nivolumab plus ipilimumab versus standard of care in non-clear cell RCC, though heterogeneity exists.

KarXT Approval Faces Scrutiny Over Potential Labeling Issues, Analyst Warns

  • Bristol-Myers Squibb's KarXT, aimed at treating schizophrenia, faces potential FDA approval hurdles due to labeling concerns regarding cardiovascular risks and food effects.
  • An analyst from Morgan Stanley maintains a Sell rating on BMY stock, anticipating a negative market reaction if KarXT's label includes restrictive cardiovascular monitoring measures.
  • Investor expectations lean towards a positive outcome with a clean label, which would likely result in a modest increase in BMY’s stock value, but labeling issues could hinder market performance.
  • Substantial growth in BMY's stock from KarXT would likely require significant contribution from the Alzheimer’s disease psychosis indication or failure of ABBV’s emraclidine.

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