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Cabozantinib/Atezolizumab Fails to Meet OS Endpoint in mCRPC, Regulatory Submissions Limited

• The Phase III CONTACT-02 trial evaluated cabozantinib plus atezolizumab versus a second novel hormonal therapy in metastatic castration-resistant prostate cancer (mCRPC). • While the combination showed a positive trend in overall survival (OS), it did not reach statistical significance (HR: 0.89; 95% CI: 0.72-1.10; P=0.296). • Ipsen will not pursue regulatory submissions for the cabozantinib/atezolizumab combination in mCRPC in countries outside the US and Japan, despite a statistically significant PFS benefit. • The combination demonstrated a statistically significant benefit in progression-free survival (PFS) and showed promising OS benefit in patients with liver and bone metastases.

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

NCT04446117Active, Not RecruitingPhase 3
Exelixis
Posted 6/30/2020

Keytruda Shows Sustained Survival Benefit in Advanced Melanoma After 10 Years

  • Ten-year follow-up data from the KEYNOTE-006 trial demonstrates a sustained overall survival (OS) benefit for Keytruda (pembrolizumab) compared to ipilimumab in advanced melanoma.
  • The 10-year OS rate for Keytruda was 34.0% versus 23.6% for ipilimumab, with Keytruda reducing the risk of death by 29% (HR=0.71).
  • Median OS for Keytruda was more than double that of ipilimumab (32.7 months versus 15.9 months), highlighting the long-term efficacy of pembrolizumab.
  • Keytruda has shown sustained survival benefits of five years or more across multiple cancer types, marking its transformative impact on cancer treatment.

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

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

Daiichi Sankyo's DS-9606 Shows Early Promise in Advanced Solid Tumors Expressing CLDN6

  • DS-9606, a CLDN6-directed antibody-drug conjugate, demonstrates preliminary clinical activity in heavily pretreated patients with advanced solid tumors.
  • The Phase 1 trial of DS-9606 showed manageable safety profile with no dose-limiting toxicities observed across dose levels.
  • Early efficacy signals include confirmed objective responses in germ cell, gastric/esophageal, and non-small cell lung cancers.
  • Further evaluation is ongoing to determine the recommended dose for expansion and to assess DS-9606's potential across various CLDN6-expressing tumor types.

A Study of DS-9606a in Patients With Advanced Solid Tumors

NCT05394675Active, Not RecruitingPhase 1
Daiichi Sankyo
Posted 5/31/2022

TAR-200 Shows High Complete Response Rate in BCG-Unresponsive NMIBC

  • TAR-200 monotherapy demonstrated an 84% complete response rate in patients with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ.
  • The SunRISe-1 phase 2b study evaluated TAR-200 alone or with cetrelimab, showing durable responses without reinduction in the TAR-200 monotherapy arm.
  • TAR-200 was well-tolerated, with most adverse events being grade 1 or 2, supporting its prioritized development as a monotherapy for high-risk NMIBC.
  • These results offer a potential bladder-sparing alternative for patients who are ineligible or unwilling to undergo radical cystectomy, addressing a critical unmet need.

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

NCT04919512Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 7/7/2022

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

NCT04658862Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 12/7/2020

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

NCT06211764RecruitingPhase 3
Janssen Research & Development, LLC
Posted 4/9/2024

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

NCT05714202Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 3/23/2023

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

NCT04640623Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 12/18/2020

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

  • TAR-200 monotherapy achieved an 83.5% complete response rate in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
  • Durable complete responses were observed, with 82% of patients maintaining response after a median follow-up of 9 months, suggesting long-term efficacy.
  • The safety profile of TAR-200 was favorable, with low discontinuation rates due to treatment-related adverse events, supporting its potential as a monotherapy.
  • Cetrelimab monotherapy showed a 46.4% complete response rate, while the combination of TAR-200 and cetrelimab resulted in a 67.9% complete response rate.

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

NCT04919512Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 7/7/2022

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

NCT04658862Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 12/7/2020

A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

NCT06211764RecruitingPhase 3
Janssen Research & Development, LLC
Posted 4/9/2024

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

NCT05714202Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 3/23/2023

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

NCT04640623Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 12/18/2020

LEAP-012 Trial: Lenvatinib, Pembrolizumab, and TACE Improve PFS in Intermediate-Stage HCC

  • The LEAP-012 trial demonstrated that combining lenvatinib and pembrolizumab with TACE significantly improves progression-free survival (PFS) in intermediate-stage hepatocellular carcinoma (HCC).
  • The combination therapy showed a median PFS of 14.6 months compared to 10 months with TACE alone, representing a 34% reduction in the risk of disease progression or death.
  • The objective response rate (ORR) was also higher in the combination arm (46.8%) compared to the placebo arm (33.3%), indicating enhanced clinical activity.
  • While treatment-related adverse events were more frequent in the combination arm, they were generally manageable, suggesting a favorable risk-benefit profile.

A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

NCT03778957Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/30/2018

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

NCT04246177Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/22/2020

IBI363 Receives FDA Designation, Advancing Treatment for Unspecified Condition

  • IBI363 has been granted a special designation by the FDA, marking a significant step in its development.
  • The designation aims to expedite the review process, potentially bringing IBI363 to patients sooner.
  • This regulatory milestone underscores the FDA's recognition of IBI363's potential in addressing an unmet medical need.
  • Further details regarding the specific designation type and its implications are anticipated to be disclosed.

King Hussein Cancer Center Achieves Breakthrough with CAR-T Cell Therapy

• The King Hussein Cancer Center (KHCC) has developed lab-engineered T-lymphocytes (CAR-T) for immunotherapy, offering a new treatment option for blood cancer patients. • A state-of-the-art GMP facility enables KHCC to genetically modify patient-extracted T-lymphocytes to target and eradicate cancer cells, reducing relapse rates. • This pioneering treatment provides hope for Jordanian and Arab patients who have exhausted other options, marking a significant advancement in cancer care. • KHCC is now fully equipped to independently perform CAR-T cell therapy, positioning it among the world's leading cancer centers and fostering further medical research.

Novel Therapies for Wet AMD Target Reduced Injection Burden and Broader VEGF Inhibition

  • 4D-150 gene therapy shows a nearly 90% reduction in annualized anti-VEGF injections, with stable visual acuity and CST reduction in Phase 2 interim results.
  • EYP-1901, an intravitreal tyrosine kinase inhibitor, demonstrates an 80% reduction in treatment burden and stable visual acuity over 12 months in the DAVIO 2 trial.
  • Sozinibercept, targeting VEGF-C/D in addition to VEGF-A, shows superior visual acuity compared to ranibizumab monotherapy in Phase 2b studies, with Phase 3 trials underway.
  • These advancements highlight the potential for reduced treatment burden and improved outcomes in wet AMD through diverse mechanisms of action.

Precede Bio's Liquid Biopsy Shows Promise in Determining PSMA Expression in Prostate Cancer

  • Precede Bio presented data at ESMO 2024 demonstrating its liquid biopsy platform can reveal tumor PSMA expression from a blood test.
  • The blood test results showed high correlation with PSMA-PET imaging, a standard method for assessing PSMA expression.
  • The non-invasive test could optimize patient identification for PSMA-targeted therapies, especially where PSMA-PET imaging is limited.
  • Precede Bio's platform may also be applied to other targets like DLL3 and STEAP1 to inform therapy selection.

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