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Retifanlimab Plus Chemotherapy Improves Outcomes in Advanced Anal Cancer

  • The POD1UM-303 trial showed that adding retifanlimab to carboplatin and paclitaxel significantly improved progression-free survival in patients with recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
  • Patients receiving retifanlimab plus chemotherapy had a median PFS of 9.3 months compared to 7.4 months with chemotherapy alone (HR, 0.63; P = .0006).
  • The combination therapy also demonstrated a higher overall response rate (56% vs 44%) and a longer duration of response (14.0 months vs 7.2 months).
  • Interim overall survival data favored the retifanlimab arm, suggesting a potential new standard of care for advanced SCAC.

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

FDA Approves Roche's Subcutaneous Multiple Sclerosis Treatment and Eli Lilly's Eczema Drug

  • The FDA has approved Roche's subcutaneous injection for multiple sclerosis, offering an alternative to intravenous administration and potentially expanding treatment options.
  • Eli Lilly's new eczema drug has received FDA approval for use in adults and children over 12, providing a new therapeutic option for this patient population.
  • Walgreens Boots Alliance will pay $106.8 million to resolve prescription billing fraud charges involving false claims to Medicare and Medicaid from 2009 to 2020.

WHO Prequalifies MVA-BN Vaccine for Mpox; DOH Warns Against Unauthorized Vaccines

  • The World Health Organization (WHO) has prequalified the MVA-BN vaccine, marking the first mpox vaccine to receive this designation, enhancing access in high-need communities.
  • The MVA-BN vaccine, given as a two-dose injection four weeks apart for adults over 18, shows approximately 82% effectiveness with the full regimen.
  • The Department of Health (DOH) Region 6 has issued a warning against unauthorized mpox vaccines lacking FDA approval, citing potential safety and efficacy risks.
  • WHO is also progressing with prequalification and emergency use listing procedures for two other mpox vaccines: LC-16 and ACAM2000.

Immunotherapy Combinations Show Promise in Aggressive Cancers

  • Phase III trials demonstrate that combining immunotherapy drugs with chemotherapy improves survival rates in triple-negative breast cancer (TNBC) and muscle-invasive bladder cancer.
  • The KEYNOTE-522 trial showed pembrolizumab, combined with chemotherapy, reduces cancer recurrence and improves overall survival in high-risk, early-stage TNBC patients.
  • The NIAGARA study indicates that durvalumab, when combined with chemotherapy, enhances survival rates in patients with muscle-invasive bladder cancer.
  • These findings have led to new standards of care for treating these aggressive cancers, marking a significant advancement in cancer therapy.

Pembrolizumab and Durvalumab Combinations Improve Survival in Aggressive Cancers

  • Pembrolizumab combined with chemotherapy reduces recurrence risk and improves survival in high-risk, early-stage triple-negative breast cancer (TNBC).
  • The KEYNOTE-522 trial's results have established the pembrolizumab treatment regime as the new standard of care for TNBC patients.
  • Durvalumab combined with chemotherapy improves survival in patients with muscle-invasive bladder cancer, marking a significant advancement.
  • The NIAGARA study demonstrates that adding immunotherapy to chemotherapy increases the cure rate for aggressive bladder cancer.

Pembrolizumab Shows Sustained Survival Benefit in Advanced Melanoma After 10-Year Follow-up

  • Ten-year follow-up data from the KEYNOTE-006 study demonstrates pembrolizumab's continued superiority over ipilimumab in unresectable stage III/IV melanoma.
  • Patients receiving pembrolizumab experienced a median overall survival of 32.7 months compared to 15.9 months with ipilimumab, with 10-year OS rates of 34% and 23.6%, respectively.
  • A second course of pembrolizumab in patients who initially responded showed promising efficacy, with a median modified PFS of 51.8 months.
  • The findings support pembrolizumab as a standard-of-care treatment, providing long-term benefits for patients with advanced melanoma.

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)

NCT01866319CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 8/28/2013

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

NCT03486873RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 8/21/2018

Olaparib/Cediranib Combination Fails to Improve Survival in Relapsed Ovarian Cancer

  • The phase 3 ICON9 trial investigated olaparib plus cediranib versus olaparib alone as maintenance therapy for relapsed platinum-sensitive ovarian cancer.
  • The combination of olaparib and cediranib did not significantly improve progression-free survival compared to olaparib monotherapy (HR = 0.84; 95% CI, 0.65-1.07; P = .24).
  • Overall survival was also not significantly different between the two arms, with median OS of 37.8 months for olaparib and 37.2 months for the combination (HR = 0.92; 95% CI, 0.67-1.26; P = .81).
  • The safety profile of the combination was consistent with the known toxicities of each agent, with slightly higher rates of certain grade 3 or higher adverse events.

Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients

NCT03278717Unknown StatusPhase 3
University College, London
Posted 6/15/2018

TAR-200 Demonstrates High Complete Response Rate in BCG-Unresponsive Bladder Cancer

  • Johnson & Johnson's TAR-200 showed an 83.5% complete response rate in patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
  • The study demonstrated durable complete responses without reinduction, with 82% of patients maintaining response after a median follow-up of 9 months.
  • An estimated 12-month complete response rate of 57.4% was observed, based on Kaplan-Meier curve analysis, indicating sustained efficacy over time.
  • The risk-benefit profile favors TAR-200 monotherapy in this patient population, offering a promising treatment option.

Enhertu Shows Promise in HER2+ Breast Cancer with Brain Metastases

  • Enhertu (trastuzumab deruxtecan) demonstrates a 61.6% 12-month median progression-free survival in metastatic breast cancer patients with brain metastases.
  • The DESTINYBreast-012 trial reveals a 79% overall response rate for central nervous system metastases with Enhertu treatment.
  • Enhertu maintains a 90.3% 12-month overall survival rate in patients with active breast cancer brain metastases, indicating a significant clinical benefit.
  • Analysts predict Enhertu will dominate the ADC market, reaching $11.2 billion in global sales by 2030, surpassing Kadcyla and Tukysa.

MediLink's YL201 Demonstrates Promising Activity in Small Cell Lung Cancer and Other Solid Tumors

  • MediLink Therapeutics presented Phase I clinical data for YL201, a B7H3-targeting antibody-drug conjugate, at ESMO 2024, showcasing its potential in treating advanced solid tumors.
  • In patients with extensive-stage small cell lung cancer (ES-SCLC), YL201 achieved an overall response rate (ORR) of 68.1% and a median progression-free survival (mPFS) of 6.2 months.
  • A global clinical trial collaboration with Amgen will evaluate YL201 in combination with Amgen's IMDELLTRA™ for ES-SCLC, exploring a novel synergistic mechanism of action.
  • YL201 monotherapy has demonstrated encouraging efficacy in ES-SCLC, prompting MediLink to actively prepare for Phase 3 studies in SCLC and nasopharyngeal carcinoma (NPC).

A Study YL201 in Patients With Selected Advanced Solid Tumors

NCT06057922RecruitingPhase 1
MediLink Therapeutics (Suzhou) Co., Ltd.
Posted 9/22/2023

A Study of YL201 in Patients with Advanced Solid Tumors

NCT05434234RecruitingPhase 1
MediLink Therapeutics (Suzhou) Co., Ltd.
Posted 5/25/2022

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