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SystImmune to Present Updated Izalontamab Brengitecan Data for HER2-Negative Breast Cancer at ESMO Breast 2025

Oncology
  • SystImmune will present updated Phase 1 data on izalontamab brengitecan (iza-bren), a novel EGFRxHER3 bispecific antibody-drug conjugate, at ESMO Breast Cancer 2025 in Munich, Germany.
  • The data shows encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, building on previously reported results at SABCS 2024.
  • Iza-bren, jointly developed by SystImmune and Bristol Myers Squibb, demonstrates strong clinical efficacy with a manageable safety profile, potentially addressing significant unmet needs in breast cancer treatment.

Dana-Farber Cancer Institute Launches Phase II Trials Testing Immunotherapy in Meningioma and Melanoma

Oncology
  • Dana-Farber Cancer Institute is conducting two Phase II clinical trials evaluating immunotherapy approaches for different cancer types, including nivolumab for progressive meningiomas and dostarlimab for resectable melanoma.
  • The meningioma trial (15-490) tests nivolumab alone or in combination with radiation therapy in patients with WHO grade I-III progressive or recurrent meningiomas, including those who have failed prior radiation therapy.
  • The melanoma trial (21-201) evaluates neoadjuvant dostarlimab in patients with cutaneous or unknown primary melanoma at various AJCC stages, requiring measurable disease and adequate organ function.
  • Both studies have specific inclusion criteria regarding prior treatments, with the meningioma trial allowing unlimited prior therapies while the melanoma trial excludes patients with prior PD-1/PD-L1 inhibitor treatment.

Nivolumab Shows Promise in Refractory Biliary Tract Cancer with 22% Response Rate in Phase II Trial

Oncology
  • A phase II study of nivolumab in 54 patients with refractory biliary tract cancer demonstrated a 22% partial response rate and 60% disease control rate with median overall survival of 14.22 months.
  • The anti-PD-1 antibody was well tolerated with only 20.4% of patients experiencing grade III/IV treatment-related adverse events, and no discontinuations due to toxicity.
  • A separate randomized phase 2 trial combining stereotactic body radiotherapy with nivolumab/ipilimumab showed 31% clinical benefit rate but limited overall response rate of 11.9%.
  • These results support further investigation of immunotherapy approaches in biliary tract cancer, a disease with limited treatment options and poor prognosis.

Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers

NCT02829918CompletedPhase 2
H. Lee Moffitt Cancer Center and Research Institute
Posted 10/5/2016

Immune Checkpoint Inhibition in Combination With Radiation Therapy in Pancreatic Cancer or Biliary Tract Cancer Patients

NCT02866383CompletedPhase 2
Herlev Hospital
Posted 11/1/2016

CytomX Therapeutics Initiates Combination Therapy Arm in Phase 1 Melanoma Trial

Oncology
  • CytomX Therapeutics has dosed the first patient in a combination arm studying CX-801 with Keytruda (pembrolizumab) for patients with metastatic melanoma.
  • The Phase 1 trial aims to evaluate safety, tolerability, and preliminary efficacy of this novel combination approach targeting advanced melanoma patients.
  • This study represents a significant step in exploring how CX-801's mechanism may potentially enhance the effectiveness of established immunotherapy treatments.

Yuhan's Lung Cancer Drug Leclaza Secures European Approval in Combination Therapy

Precision MedicineOncologyDrug ApprovalTargeted Therapy
  • Yuhan Corporation's third-generation EGFR-TKI lazertinib (Leclaza) has received European Commission approval in combination with J&J's Rybrevant for first-line treatment of EGFR-mutated non-small cell lung cancer.
  • The Phase 3 MARIPOSA study demonstrated the combination therapy reduced disease progression risk by 30% compared to osimertinib, with median progression-free survival of 23.7 months versus 16.6 months.
  • This milestone marks the first Korean anticancer drug approved in both the U.S. and Europe, triggering a $30 million payment to Yuhan as part of their $1.255 billion licensing deal with Johnson & Johnson.

CEL-SCI Secures $5 Million in Public Offering to Advance Multikine Cancer Immunotherapy

Oncology
  • CEL-SCI Corporation has priced a $5 million public offering of 16.13 million shares at $0.31 per share to fund continued development of Multikine, a first-line cancer immunotherapy.
  • The company has received FDA clearance to conduct a confirmatory Registration Study for Multikine in 212 patients with locally advanced head and neck cancer who have specific characteristics.
  • Multikine is designed to boost the immune system's ability to target tumors while it's still intact, potentially improving survival outcomes for cancer patients.

FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Monoclonal AntibodyOncologyFDA Approval
  • The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
  • In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
  • This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.

Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)

NCT03924986CompletedPhase 3
BeiGene
Posted 3/27/2019

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843CompletedPhase 3
BeiGene
Posted 1/26/2018

Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

NCT04379635Active, Not RecruitingPhase 3
BeiGene
Posted 5/29/2020

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03783442CompletedNot Applicable
BeiGene
Posted 12/11/2018

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

NCT03777657CompletedPhase 3
BeiGene
Posted 12/13/2018

Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04005716CompletedPhase 3
BeiGene
Posted 7/22/2019

Endevica Bio Advances TCMCB07 to Phase 2 Trial for Preventing Chemotherapy-Induced Weight Loss

Oncology
  • Endevica Bio has received FDA authorization to begin a Phase 2 clinical trial of TCMCB07 (B07), a peptide designed to prevent weight loss in stage 4 metastatic colorectal cancer patients undergoing chemotherapy.
  • The trial will enroll 100 patients who will receive B07 before and during chemotherapy, targeting cachexia - a life-threatening wasting syndrome affecting millions of cancer patients worldwide.
  • TCMCB07, a melanocortin-3/4 antagonist peptide, has shown promising results in Phase 1 trials and preclinical studies, demonstrating its ability to preserve lean muscle mass and improve appetite in cancer treatment settings.

PeproMene Bio Secures $11 Million Investment to Advance BAFF-R CAR T-Cell Therapy for Follicular Lymphoma

CAR-TOncology
  • PeproMene Bio has received an $11 million investment from the Institute for Follicular Lymphoma Innovation to develop PMB-CT01, a novel BAFF-R CAR T-cell therapy for relapsed/refractory follicular lymphoma.
  • Early clinical results show promising efficacy with a 100% complete response rate in six non-Hodgkin lymphoma patients and minimal side effects, including in patients who relapsed after CD19 CAR T-cell therapy.
  • PMB-CT01 targets the BAFF-R receptor, which is crucial for B-cell survival, potentially making it difficult for tumor cells to escape therapy through antigen loss, a common limitation of current CD19-targeted therapies.

BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL

NCT05370430RecruitingPhase 1
PeproMene Bio, Inc.
Posted 6/13/2022

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL

NCT04690595RecruitingPhase 1
PeproMene Bio, Inc.
Posted 5/18/2021

Federal Jury Awards Lindis Biotech $50 Million in Patent Infringement Case Against Amgen's Blincyto

Oncology
  • A Delaware federal jury found Amgen's Blincyto cancer drug willfully infringes two Lindis Biotech patents for leukemia treatment administration methods.
  • The jury awarded approximately $50 million in damages based on over $2.2 billion in U.S. sales of Blincyto, while upholding the validity of both patents.
  • Amgen has filed a motion for judgment as a matter of law challenging the infringement findings and damages calculations.
  • Blincyto generated $566 million in U.S. sales for Amgen in fiscal year 2023, representing a 48% increase over the previous year.

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