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Clinical Trial News

Opdivo and Yervoy Combination Shows Durable Survival Benefit in Advanced Melanoma After 10 Years

• The combination of nivolumab (Opdivo) and ipilimumab (Yervoy) demonstrated a median overall survival of 71.9 months in advanced melanoma patients. • After 10 years, 43% of patients treated with the Opdivo and Yervoy combination were still alive, with many not requiring subsequent therapy. • The objective response rate (ORR) after 10 years was 58.3% in the Opdivo plus Yervoy group, highlighting the long-term efficacy of the combination. • The safety profile of the Opdivo and Yervoy combination remained consistent with previous reports, with no new safety signals identified.

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

NCT01844505CompletedPhase 3
Bristol-Myers Squibb
Posted 6/11/2013

Imfinzi and Imjudo Combo Shows Unprecedented 5-Year Survival in Liver Cancer

  • The combination of Imfinzi and Imjudo demonstrated a significant improvement in five-year overall survival rates compared to sorafenib for unresectable hepatocellular carcinoma (uHCC).
  • The HIMALAYA trial showed that nearly 20% of patients treated with Imfinzi plus Imjudo were alive at five years, compared to 9.4% with sorafenib.
  • The STRIDE regimen, utilizing a single dose of Imjudo with Imfinzi, reduced the risk of death by 24% compared to sorafenib, marking a major advancement in uHCC treatment.
  • These findings establish a new survival benchmark and reinforce the use of the Imfinzi and Imjudo combination as a first-line treatment for advanced liver cancer.

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/11/2017

Chemo-Free Triplet Therapy Shows Promise in Richter Transformation

  • A phase II trial (MOLTO) found that a chemotherapy-free regimen of atezolizumab, venetoclax, and obinutuzumab yielded a 67.9% overall response rate in patients with Richter transformation.
  • The triplet therapy demonstrated durable remissions and prolonged survival, suggesting it could become a potential first-line treatment for this aggressive lymphoma variant.
  • The study is particularly relevant as the regimen doesn't rely on BTK inhibitors, offering an option for patients previously treated with BCL-2 inhibitors for chronic lymphocytic leukemia.
  • Further research is needed to identify biomarkers that can predict which patients will benefit most from this treatment approach.

ObinutuzuMab AtezOlizumab and VenetocLax in RichTer transfOrmation

NCT04082897Active, Not RecruitingPhase 2
Niguarda Hospital
Posted 10/4/2019

FDA Approves Eli Lilly's Ebglyss (lebrikizumab) for Eczema Treatment in Adults and Children

• The FDA has approved Eli Lilly's Ebglyss (lebrikizumab) for treating moderate-to-severe eczema in adults and children aged 12 and older. • Ebglyss, a monoclonal antibody targeting the IL-13 protein, offers a new first-line biologic option when topical treatments are insufficient. • Clinical trials involving over 1,000 patients demonstrated Ebglyss's efficacy in controlling eczema symptoms, with a less frequent dosing schedule than some alternatives. • The approval provides a new treatment option for the nearly 16.5 million adults in the U.S. affected by eczema, with availability expected in the coming weeks.

Cabozantinib Shows Promise in Advanced Neuroendocrine Tumors in Phase III CABINET Trial

  • Cabozantinib significantly improves progression-free survival (PFS) in patients with advanced pancreatic neuroendocrine tumors (pNET) compared to placebo.
  • The CABINET trial also demonstrated that cabozantinib markedly enhanced PFS in patients with advanced extra-pancreatic NET (epNET).
  • Cabozantinib's safety profile in the study was consistent with previous trials, with manageable side effects and no new safety concerns identified.
  • The FDA has accepted Exelixis' sNDA for cabozantinib with a target action date of April 3, 2025, potentially offering a new standard of care.

Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

NCT03375320Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 10/26/2018

AMBASSADOR Trial: Pembrolizumab Shows Sustained DFS Benefit in Urothelial Carcinoma

  • The phase 3 AMBASSADOR trial evaluated adjuvant pembrolizumab in high-risk muscle-invasive urothelial carcinoma patients after surgery.
  • Extended follow-up data presented at ESMO 2024 confirms the initial disease-free survival (DFS) benefit with pembrolizumab.
  • The trial's hazard ratio of approximately 0.7 supports pembrolizumab's potential role in adjuvant therapy for this patient population.
  • Outcomes did not show a trend for improvement in PD-L1 high population, but there was a trend for improved outcomes in bladder primary.

Taletrectinib Shows Durable Responses in Advanced ROS1-Positive NSCLC

  • Integrated analysis of TRUST-I and TRUST-II trials demonstrates taletrectinib's high overall response rate (ORR) in ROS1 TKI-naive NSCLC patients, reaching 88.8%.
  • In ROS1 TKI-pretreated patients, taletrectinib achieved a 55.8% ORR, with a slightly higher 61.5% ORR in those with G2032R mutations.
  • The study highlights taletrectinib's favorable safety profile, supporting its potential as a best-in-class ROS1 TKI for advanced ROS1-positive NSCLC.
  • Taletrectinib demonstrated notable intracranial activity, with confirmed intracranial ORRs of 76.5% and 65.6% in TKI-naive and pretreated patients with brain metastases, respectively.

A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

NCT04395677Active, Not RecruitingPhase 2
AnHeart Therapeutics Inc.
Posted 7/7/2020

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

NCT04919811RecruitingPhase 2
Nuvation Bio Inc.
Posted 9/1/2021

FDA Lifts Partial Clinical Hold on Azenosertib Trials in Advanced Solid Tumors

• The FDA has lifted the partial clinical hold on trials evaluating azenosertib, a WEE1 inhibitor, in patients with advanced solid tumors, allowing studies to resume enrollment. • The hold was initiated in June 2024 due to two deaths from presumed sepsis in the DENALI trial, but the FDA has now reviewed and approved Zentalis Pharmaceuticals' response package. • Azenosertib is being investigated as a monotherapy and in combination for platinum-resistant ovarian cancer and uterine serous carcinoma, with additional data expected in Q4 2024.

A Study of ZN-c3 in Participants With Solid Tumors

NCT04158336RecruitingPhase 1
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Posted 11/1/2019

A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

NCT04814108RecruitingPhase 2
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Posted 7/28/2021

A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT05128825RecruitingPhase 2
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Posted 2/17/2022

P-BCMA-ALLO1 Granted FDA RMAT Designation for Relapsed/Refractory Multiple Myeloma

• The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-ALLO1 for relapsed/refractory multiple myeloma. • P-BCMA-ALLO1 is an investigational stem cell memory T-cell-based allogeneic CAR T-cell therapy currently in phase 1/1b clinical development. • Early phase 1 data showed promising efficacy and safety with quick off-the-shelf patient access and no graft-vs-host disease. • The RMAT designation underscores P-BCMA-ALLO1's potential to address unmet needs in heavily pretreated multiple myeloma patients.

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

NCT04960579RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 5/5/2022

Epitomee Medical's Novel Ingestible Capsule Receives FDA Clearance for Weight Management

  • Epitomee Medical's capsule, a drug-free device, has been cleared by the FDA for weight management in adults with a BMI of 25-40 alongside diet and exercise.
  • The capsule works by creating a sensation of fullness in the stomach, aiding in weight loss through a purely mechanical action within the GI tract.
  • Clinical trials demonstrated significantly better weight loss in the device group compared to the control, with 55.5% achieving at least 5% total body weight reduction.
  • The device showed a favorable safety profile, with no serious adverse device effects reported and better improvement in quality of life reported by patients.

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