MedPath

Clinical Trial News

Pembrolizumab Plus Chemotherapy Improves Overall Survival in High-Risk Early-Stage TNBC

  • Neoadjuvant pembrolizumab with chemotherapy, followed by adjuvant pembrolizumab, significantly improves overall survival (OS) in high-risk early-stage triple-negative breast cancer (TNBC).
  • The KEYNOTE-522 trial demonstrated a 34% reduction in the risk of death with the pembrolizumab regimen compared to chemotherapy alone, marking a significant milestone.
  • The 5-year OS rate was 86.6% for the pembrolizumab arm versus 81.7% for the chemotherapy-placebo arm, showcasing a clinically meaningful survival benefit.
  • Pembrolizumab in combination with chemotherapy is now considered a standard of care for stage II and III TNBC, particularly benefiting patients with non-pCR.

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

NCT03036488Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 3/7/2017

Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab

NCT02926196Active, Not RecruitingPhase 3
Istituto Oncologico Veneto IRCCS
Posted 6/17/2016

TORL Bio Presents Promising Phase 1 Data for CLDN6-Targeted ADC TORL-1-23 in Advanced Cancers

  • TORL-1-23 demonstrates clinically meaningful and durable responses in patients with Claudin 6 positive platinum-resistant ovarian cancer, with a manageable safety profile.
  • The Phase 1 study included patients with ovarian, non-small cell lung cancer, and other CLDN6+ cancers, with expansion cohorts currently under investigation.
  • Data supports the initiation of a registration-enabling Phase 2 study in patients with CLDN6+ platinum-resistant ovarian cancer, addressing a significant unmet need.
  • The most common adverse events were grade 1 or 2 fatigue, peripheral neuropathy, and alopecia, with neutropenia being the most frequent grade 3+ adverse event.

First in Human Study of TORL-1-23 in Participants With Advanced Cancer

NCT05103683RecruitingPhase 1
TORL Biotherapeutics, LLC
Posted 11/17/2021

Incyte's Zynyz Shows Promise in Frontline Anal Cancer Treatment

  • Incyte's Zynyz, combined with chemotherapy, significantly reduced the risk of disease progression or death in patients with squamous cell carcinoma of the anal canal (SCAC).
  • The POD1UM-303 trial demonstrated a 37% reduction in disease progression or death and extended median progression-free survival to 9.3 months compared to chemotherapy alone.
  • Zynyz also showed a trend towards improved overall survival, with a 30% improvement compared to the control group, potentially establishing it as a new standard of care.
  • Incyte's CDK2 inhibitor, INCB123667, also demonstrated activity against various solid tumors, particularly ovarian cancer, with a phase 3 program planned for 2025.

FDA Grants Breakthrough Therapy Designation to Sanbexin Sublingual Tablets for Acute Ischemic Stroke

  • Simcere Pharmaceuticals' Sanbexin sublingual tablets receive Breakthrough Therapy designation from the FDA for acute ischemic stroke (AIS) treatment.
  • The designation is based on Phase III clinical trial data demonstrating significant improvements in neurological recovery and independent living ability compared to placebo.
  • Sanbexin is a novel formulation of edaravone and dexborneol designed for rapid sublingual absorption, offering potential for early stroke intervention.
  • The Breakthrough Therapy designation is expected to expedite clinical development and regulatory review of Sanbexin in the United States.

Imfinzi Plus Imjudo Shows Unprecedented 5-Year Survival in Advanced Liver Cancer

  • AstraZeneca's Imfinzi plus Imjudo (STRIDE regimen) demonstrated a significant overall survival benefit in patients with unresectable hepatocellular carcinoma (HCC).
  • At five years, 19.6% of patients on the STRIDE regimen were alive compared to 9.4% on sorafenib, marking the longest survival follow-up in a Phase III immunotherapy trial for HCC.
  • The STRIDE regimen reduced the risk of death by 24% compared to sorafenib (HR 0.76; 95% CI: 0.65-0.89), establishing a new benchmark in advanced liver cancer treatment.
  • The safety profile of the STRIDE regimen was consistent with previous findings, reinforcing its potential as a first-line treatment option for advanced HCC.

Imfinzi Plus Imjudo Shows Unprecedented Survival in Advanced Liver Cancer

  • The combination of Imfinzi and Imjudo has demonstrated unprecedented overall survival (OS) in advanced liver cancer, with one in five patients surviving five years.
  • The Phase III HIMALAYA trial showed a significant improvement in OS for the Imfinzi plus Imjudo arm compared to sorafenib, marking a potential new standard of care.
  • AstraZeneca's ongoing GI cancer program includes multiple modalities targeting various GI cancers, aiming to improve patient outcomes in this challenging disease area.

Sanbexin Sublingual Tablets Granted FDA Breakthrough Therapy Designation for Ischemic Stroke

  • Simcere Pharmaceuticals' Sanbexin sublingual tablets receive Breakthrough Therapy designation from the FDA for ischemic stroke treatment.
  • The designation aims to expedite the development and regulatory review of Sanbexin, addressing a critical unmet need in stroke therapy.
  • Phase III clinical trial data demonstrated significant improvements in neurological recovery and autonomy for ischemic stroke patients compared to placebo.
  • Sanbexin's unique sublingual formulation allows for rapid absorption, potentially enhancing treatment flexibility and improving patient outcomes.

FDA Approves Roche's Ocrevus ZUNOVO for Relapsing and Progressive Multiple Sclerosis

  • The FDA has approved Ocrevus ZUNOVO (ocrelizumab & hyaluronidase-ocsq) for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
  • Ocrevus ZUNOVO is administered via a roughly 10-minute subcutaneous injection twice a year by a healthcare professional.
  • The approval is based on the Phase III OCARINA II trial, demonstrating similar efficacy and safety to the IV formulation of Ocrevus.
  • Ocrevus and Ocrevus ZUNOVO remain the only therapies approved for both RMS and PPMS, offering increased flexibility for patients and providers.

Rinatabart Sesutecan Shows Promise in Heavily Pretreated Ovarian and Endometrial Cancers

  • Rinatabart sesutecan (Rina-S) demonstrated a 50% confirmed objective response rate (ORR) in ovarian cancer patients at 120 mg/m2 Q3W, regardless of FRα expression levels.
  • The Phase 1/2 study results support Rina-S potential in advanced ovarian and endometrial cancers, especially in platinum-resistant cases, warranting further Phase 3 evaluation.
  • Common treatment-emergent adverse events included anemia, neutropenia, and nausea, with infrequent dose reductions and no observed ocular toxicities or interstitial lung disease.

Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

NCT05579366RecruitingPhase 1
ProfoundBio US Co.
Posted 12/7/2022

FDA's Biosimilar Landscape: Growing Market Share and Policy Changes Shape Future Access

  • The U.S. biosimilars market is experiencing rapid growth, with 56 FDA-approved products and projected sales reaching up to $129 billion over the next 5 years, demonstrating increasing adoption in healthcare systems.
  • Recent policy changes include CMS implementing temporary payment increases for biosimilars under Medicare Part B, offering ASP plus 8% reimbursement to encourage market competition and improve accessibility.
  • Healthcare systems implementing strategic biosimilar programs have achieved significant cost savings, with Providence St. Joseph Health system reporting $26.9 million in savings and 62% biosimilar adoption over 22 months.

Trending News

1

Lilly's Once-Weekly Insulin Efsitora Alfa Achieves Non-Inferiority in Phase 3 Trials, Reducing Injection Burden by 300 Doses Annually

3 days ago
2

Otsuka Pharmaceutical Secures Global Rights to HBM7020 BCMAxCD3 Bispecific T-Cell Engager for Autoimmune Diseases

2 days ago
3

Nuvalent to Present Pivotal Data for ROS1-Selective Inhibitor Zidesamtinib in Advanced Lung Cancer

a day ago
4

Novo Nordisk's Mim8 Shows Safe Direct Switch from Emicizumab in Phase 3b Hemophilia A Trial

3 days ago
5

Glenmark Launches Tevimbra, First Immuno-Oncology Drug in India for Lung and Esophageal Cancer Treatment

a day ago
6

Roche's NXT007 Achieves Zero Bleeds in Phase I/II Hemophilia A Trial, Advances to Phase III

2 days ago
7

EMA Recommends Approval of Alvotech's Biosimilar to Eylea for Eye Disorders

2 days ago
8

Carisma Therapeutics and OrthoCellix Announce $25M Merger to Advance Phase 3 Knee Cartilage Therapy

2 days ago
9

Utopia Therapeutics Secures $1.5M for Novel Obesity Vaccine UT009

2 days ago
10

Lundbeck's Lu AG13909 Receives Orphan Drug Designation for Congenital Adrenal Hyperplasia Treatment

a day ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy