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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.

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.

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

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

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) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03783442CompletedNot Applicable
BeiGene
Posted 12/11/2018

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

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

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

Glenmark's Blood Cancer Drug ISB 2001 Shows 83% Response Rate in Phase 1 Multiple Myeloma Trial

Oncology
  • Glenmark Pharmaceuticals' trispecific antibody ISB 2001 demonstrated an 83% overall response rate in heavily pretreated multiple myeloma patients during Phase 1 clinical trials.
  • The study showed that 20% of the 18 patients achieved complete cancer remission, with the drug displaying a favorable safety profile and durable responses.
  • Clinical experts suggest ISB 2001 could revolutionize treatment for patients who have exhausted currently approved therapies, potentially comparing favorably with existing bispecific options.
  • The positive results led to a 4% surge in Glenmark's stock price, with the company's shares outperforming the broader pharmaceutical index.

Immunochemotherapy Shows Promise for Borderline Resectable Esophageal Cancer Conversion Surgery

Oncology
  • A retrospective study of 40 patients with borderline resectable esophageal squamous cell carcinoma demonstrated that PD-1 inhibitors combined with chemotherapy achieved a 67.5% conversion surgery rate and 57.5% R0 resection rate.
  • The immunochemotherapy approach showed significantly lower toxicity compared to conventional regimens, with only 10% grade 3-4 adverse events versus 31.9-79.4% reported with traditional protocols.
  • Patients achieving clinical downstaging after induction therapy experienced significantly better overall survival and progression-free survival outcomes compared to those without downstaging.
  • The pathological complete remission rate of 27.5% was notably higher than the 14.8-18.5% typically seen with conventional chemotherapy alone for this challenging patient population.

Aktis Oncology's First-in-Class Nectin-4 Radiopharmaceutical AKY-1189 Shows Promising Tumor Uptake Across Multiple Cancer Types

Targeted TherapyOncology
  • Aktis Oncology's AKY-1189, the industry's only Nectin-4-directed radioligand therapy, demonstrated significant tumor uptake across multiple solid tumor types in first human data from 15 evaluable patients.
  • The novel miniprotein radiopharmaceutical showed excellent uptake in ER-positive breast cancer and bladder cancer, with potential applications beyond current Nectin-4 therapy Padcev.
  • Dosimetry analysis in eight patients revealed a wide therapeutic index with transient kidney uptake and no treatment-emergent adverse events, supporting progression to formal clinical trials.
  • The company is preparing to initiate phase 1 studies in South Africa and the US in 2025, following a recent $60 million deal with Lilly and $175 million Series B financing.

AI Support Significantly Improves HER2 Scoring Accuracy in Breast Cancer Diagnosis

AIPrecision MedicineOncology
• A new study published in JCO Precision Oncology demonstrates that Ibex Medical Analytics' AI technology significantly improves pathologists' accuracy and consistency in HER2 biomarker scoring for breast cancer.
• The multi-center study showed AI-assisted pathologists achieved higher inter-observer agreement (83.7% vs 75%) and improved accuracy in identifying challenging HER2-low cases, which is critical for determining eligibility for new targeted therapies.
• The "zero-click" decision support tool demonstrated exceptional robustness across multiple labs, antibodies, scanners, and patient demographics, offering particular value in distinguishing between HER2 0 and 1+ cases.

Bristol Myers Squibb Initiates Two Phase I Trials Testing Novel Therapies for Advanced Solid Tumors and Relapsed/Refractory Lymphomas

Oncology
  • Bristol Myers Squibb has launched two Phase I clinical trials evaluating experimental therapies BMS-986408 for advanced solid tumors and BMS-986458 for relapsed/refractory non-Hodgkin lymphoma.
  • The BMS-986408 study targets patients with histologically confirmed, advanced, unresectable or metastatic solid malignancies who have exhausted existing treatment options.
  • The BMS-986458 trial focuses on patients with relapsed/refractory DLBCL and follicular lymphoma who have received at least two prior lines of therapy.
  • Both studies exclude patients with autoimmune diseases and require specific performance status criteria for enrollment.

POSITIVE Trial Demonstrates Safe Breastfeeding During Endocrine Therapy Break for HR+ Breast Cancer Patients

Oncology
  • The POSITIVE trial showed that breastfeeding is feasible for young patients with hormone receptor-positive breast cancer who conceived during a planned interruption of endocrine therapy, with a median breastfeeding duration of 4.4 months.
  • Among 196 patients who breastfed, breast cancer recurrence rates remained low at 1.1% at 12 months and 3.6% at 24 months, comparable to those who did not breastfeed.
  • The study represents the largest prospective evaluation of breastfeeding patterns in young HR-positive breast cancer survivors, supporting the incorporation of breastfeeding counseling into individualized patient care.

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

NCT02308085Active, Not RecruitingNot Applicable
ETOP IBCSG Partners Foundation
Posted 12/4/2014

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