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TOP STORIES from the week

SANOVO Trial Demonstrated Significant PFS Benefit of ORPATHYS + TAGRISSO in 1L Patients with MET-Overexpressing EGFR-mutated Lung Cancer in China

FDA clears IND application for ADI-212 for the treatment of patients with metastatic CRPC

DSMB recommends termination of Ph 2 trial of adjuvant BNT122-01 in patients with circulating tumor DNA-positive, surgically resected Stage II/III CRC

Ziihera® (zanidatamab-hrii) + Chemo Demonstrates Statistically Significant OS Benefit vs Trastuzumab + Chemo in 1L HER2+ Advanced GEA

DB-1317 Granted FDA Fast Track Designation for Treatment of Advanced Pancreatic Ductal Adenocarcinoma

FDA approves SC Sarclisa (isatuximab-irfc) Escena + SOC for multiple myeloma patients across all existing indications of Sarclisa IV formulation

DB-1317 Granted FDA Fast Track Designation for Treatment of Advanced Pancreatic Ductal Adenocarcinoma

Ziihera® (zanidatamab-hrii) + Chemo Demonstrates Statistically Significant OS Benefit vs Trastuzumab + Chemo in 1L HER2+ Advanced GEA

IDMC recommends to continue patient enrolment in Ph 1 ZIMA-101 trial in solid tumor patients

Ipsen completes acquisition of Kartos Therapeutics, strengthening late-stage Oncology pipeline

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Drug approvals

FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab + Chemo in 1L HER2+ Advanced Gastroesophageal Adenocarcinoma

FDA Approves RASONQUE™ (daraxonrasib) for Metastatic Pancreatic Cancer

European Commission approves TECVAYLI (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma

FDA Grants Accelerated Approval to ZENBEXUS in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma

Regulatory news

FDA clears IND application for ADI-212 for the treatment of patients with metastatic CRPC

DB-1317 Granted FDA Fast Track Designation for Treatment of Advanced Pancreatic Ductal Adenocarcinoma

NMPA Approves ATLED® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma

SYS6090 (JMT108) Granted Fast Track Designation by FDA for Treatment of Patients with MSS/pMMR mCRC

Trial results

SANOVO Trial Demonstrated Significant PFS Benefit of ORPATHYS + TAGRISSO in 1L Patients with MET-Overexpressing EGFR-mutated Lung Cancer in China

Ziihera® (zanidatamab-hrii) + Chemo Demonstrates Statistically Significant OS Benefit vs Trastuzumab + Chemo in 1L HER2+ Advanced GEA

Confirmed Durable Partial Response Achieved in Ph 1 Trial of RAD204 in Patients with Advanced Solid Tumors Post-Immunotherapy

Ivonescimab + Chemo Global Ph 3 HARMONi Primary Analysis Results Published in The Lancet Oncology

trial status

DSMB recommends termination of Ph 2 trial of adjuvant BNT122-01 in patients with circulating tumor DNA-positive, surgically resected Stage II/III CRC

First Patient Dosed in Ph 3 Study of ASP2138 in CLDN18.2+ve and HER2-neg locally advanced unresectable or metastatic GEJ adenocarcinoma

First patient dosed in Ph 1 KOALA trial of KMCAR™ T-cell therapy in patients with R/R kappa-restricted multiple myeloma 

First patient dosed in Ph 1 trial of ABSK211 for advanced solid tumors with KRAS alterations

Business news

DualityBio Enters a Global Collaboration and License Agreement with Genentech to Develop Next-Gen ADCs Built on DualityBio’s DUPAC Novel-Payload Platform

Emmaus Life Sciences Announces Agreement for Evaluation of L-glutamine for Pancreatic Cancer

IDEAYA Biosciences Announces Clinical Collaboration with Genentech in MTAP-Deleted KRAS G12D-Mutant Pancreatic Cancer

Ipsen completes acquisition of Kartos Therapeutics, strengthening late-stage Oncology pipeline

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