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TOP STORIES from the week

AstraZeneca completes global license agreement for oral EGFR inhibitor Zegfrovy for lung cancer

Styx Biotechnologies Announces Strategic Agreement with ZoeNCure Therapeutics to Accelerate Next-Gen ADC Pipeline to Clinic

INBRX-106 Nearly Doubles Response Rate and Achieves Interim Median PFS of 9.6 months in Ph 2 HNSCC Study

Treeline Announces Clinical Trial Collaboration and Supply Agreement with Roche to Evaluate TLN-121 with CD20xCD3 T-Cell-Engaging Bispecific Antibodies

Positive Topline Results Announced from Ph 3 CERVINO Trial Showing Etentamig Significantly Improved Response Rate and PFS in RRMM Patients

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

Positive Topline Results Announced from Ph 3 CERVINO Trial Showing Etentamig Significantly Improved Response Rate and PFS in RRMM Patients

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

Styx Biotechnologies Announces Strategic Agreement with ZoeNCure Therapeutics to Accelerate Next-Gen ADC Pipeline to Clinic

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Drug approvals

Etcamah + CDK4/6 inhibitor combo approved in the US for 1L advanced HR-positive breast cancer

Enhertu + pertuzumab approved in EU for 1L HER2-positive metastatic breast cancer

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

FDA Approves RASONQUE™ (daraxonrasib) for Metastatic Pancreatic Cancer

Regulatory news

FDA Clears IND Application for ACE723 to initiate Ph 1 trial in 1L HCC

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

Trial results

INBRX-106 Nearly Doubles Response Rate and Achieves Interim Median PFS of 9.6 months in Ph 2 HNSCC Study

Positive Topline Results Announced from Ph 3 CERVINO Trial Showing Etentamig Significantly Improved Response Rate and PFS in RRMM Patients

Imfinzi + Imdelltra demonstrated statistically significant OS & PFS improvement in 1L ES-SCLC

Positive Topline Results Announced from Registrational Ph 2 QUINTESSENTIAL Trial of GPRC5D-Directed CAR T Cell Therapy Arlocabtagene Autoleucel

trial status

Paxalisib Clinical Trial Expanded into HR+/HER2- Breast Cancer

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 

Business news

AstraZeneca completes global license agreement for oral EGFR inhibitor Zegfrovy for lung cancer

Styx Biotechnologies Announces Strategic Agreement with ZoeNCure Therapeutics to Accelerate Next-Gen ADC Pipeline to Clinic

Treeline Announces Clinical Trial Collaboration and Supply Agreement with Roche to Evaluate TLN-121 with CD20xCD3 T-Cell-Engaging Bispecific Antibodies

HUTCHMED Announces Licensing Agreement with GSK for KRAS-EGFR-Antibody Conjugate Cancer Therapy

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