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Clinical Trial News

Guselkumab (Tremfya) Approved for Ulcerative Colitis: Expanding IBD Treatment Options

  • The FDA approved guselkumab (Tremfya) for ulcerative colitis (UC) on September 11, 2024, marking a significant advancement in IBD therapeutics.
  • The approval of guselkumab adds to the growing number of treatment options available for Crohn's disease (CD) and UC, offering new hope for patients.
  • Clinicians emphasize the importance of tailoring treatment decisions to individual patient needs, considering factors like treatment preferences and potential safety risks.
  • Guselkumab's novel mechanism of action provides an alternative for patients who may not respond to or tolerate existing therapies.

Oncologica Seeks £6 Million to Advance Urine-Based Prostate Cancer Test

  • Oncologica, a Cambridge-based firm, is seeking £6 million to fund clinical trials and regulatory approval for its urine-based prostate cancer screening test.
  • The test aims to distinguish between aggressive and harmless prostate cancers, reducing the need for unnecessary biopsies and treatments.
  • Oncologica's test could revolutionize early detection of prostate cancer, potentially improving patient outcomes and reducing healthcare costs.

Retifanlimab Plus Chemotherapy Extends Progression-Free Survival in Advanced Squamous Cell Anal Carcinoma

• The phase III POD1UM-303/InterAACT2 trial demonstrated that retifanlimab combined with carboplatin and paclitaxel significantly improved progression-free survival (PFS) in patients with advanced squamous cell anal carcinoma (SCAC). • Patients receiving retifanlimab plus chemotherapy experienced a median PFS of 9.3 months compared to 7.4 months with placebo plus chemotherapy, representing a 37% reduction in the risk of cancer progression or death. • Interim overall survival (OS) data showed a strong trend towards improvement with the retifanlimab combination, with a 6-month difference compared to placebo, though OS data is not yet mature. • The combination therapy demonstrated an improved overall response rate (ORR) of 56% versus 44% and a longer duration of response (DoR) of 14 months versus 7 months with placebo, suggesting a potential new standard of care.

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

NCT04472429Active, Not RecruitingPhase 3
Incyte Corporation
Posted 1/12/2021

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

NCT03929666CompletedPhase 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

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