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TOP STORIES from the week

Patient enrollment completed in Ph 3 TIGeR-PaC Trial for Locally Advanced Pancreatic Cancer

Zipalertinib + Chemo Meet Primary PFS Endpoint in Planned Interim Analysis of Ph 3 REZILIENT3 Trial in 1L EGFR Exon 20 Insertion Mutation NSCLC

FDA clears IND application for C-CAR039 (Prizloncabtagene Autoleucel or Prizlon-cel) for the treatment of R/R LBCL

EVX-03 program discontinued to focus on initial clinical testing of EVX-05

Enhertu demonstrated statistically significant and clinically meaningful PFS improvement in HER2-mutant NSCLC in DESTINY-Lung04 Ph 3 trial

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

FDA Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma

Enhertu demonstrated statistically significant and clinically meaningful PFS improvement in HER2-mutant NSCLC in DESTINY-Lung04 Ph 3 trial

EVX-03 program discontinued to focus on initial clinical testing of EVX-05

Evexta Bio and Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced/Metastatic Breast Cancer

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Drug approvals

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

NMPA approves felzartamab (Jingfei) + lenalidomide and dexamethasone for treating multiple myeloma patients who have received at least one prior line of therapy

Ivonescimab + Chemo Approved in China by NMPA for 1L Treatment of Patients with Squamous NSCLC

FDA grants Accelerated Approval to TUDRIQEV + Nivolumab combo for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

Regulatory news

FDA clears IND application for C-CAR039 (Prizloncabtagene Autoleucel or Prizlon-cel) for the treatment of R/R LBCL

FDA Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma

US FDA Type C Statistical Methods Meeting Granted to Review 2.5-Year OS Data for OST-HER2 in Metastatic Osteosarcoma

Planned August sNDA Submission for Selinexor + Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track

Trial results

Zipalertinib + Chemo Meet Primary PFS Endpoint in Planned Interim Analysis of Ph 3 REZILIENT3 Trial in 1L EGFR Exon 20 Insertion Mutation NSCLC

Enhertu demonstrated statistically significant and clinically meaningful PFS improvement in HER2-mutant NSCLC in DESTINY-Lung04 Ph 3 trial

Final ASTRUM-002 Analysis Shows Survival Benefit with Hetronifly in Advanced non squamous NSCLC After Four Years of Follow-Up

FAILED TRIAL: Ph 2 DeFianCe study of sirexatamab (DKN-01) in 2L CRC did not meet primary endpoint of PFS improvement

trial status

Patient enrollment completed in Ph 3 TIGeR-PaC Trial for Locally Advanced Pancreatic Cancer

EVX-03 program discontinued to focus on initial clinical testing of EVX-05

IDMC recommends discontinuing the eVOLVE-Lung02 Ph 3 trial of volrustomig + chemo in 1L metastatic NSCLC with PD-L1 <50%

PDS0101 Ph 3 VERSATILE-003 trial to be discontinued to focus on the PDS0301 program

Business news

Gilead, Nucleai Announce Collaboration on Oncology ADC Programs

Vepdegestrant Now Available for U.S. Patients With ER+/HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer

Innovent Biologics and Daiichi Sankyo Enter Exclusive Agreement for VANFLYTA® Commercialization in China

Evexta Bio and Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced/Metastatic Breast Cancer

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