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TOP STORIES from the week

FDA clears IND application for ORM-1153 for Ph 1 study in patients with R/R AML and other hematologic malignancies

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

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

FDA Fast Track Designation Granted to ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma

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

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

FDA Fast Track Designation Granted to ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma

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

First Patient Dosed in MODeFIRe-1 Ph 2 Study of MRT-2359 + Apalutamide in Patients with AR Mutation-Positive Metastatic CRPC

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

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Drug approvals

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

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

Regulatory news

FDA clears IND application for ORM-1153 for Ph 1 study in patients with R/R AML and other hematologic malignancies

FDA Fast Track Designation Granted to ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma

Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer

FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study

Trial results

Ph 3 INTerpath-001 Trial of Intismeran Autogene + KEYTRUDA Met RFS and DMFS Endpoints in Patients With Completely Resected Stage IIB-IV Melanoma

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

trial status

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

First Patient Dosed in MODeFIRe-1 Ph 2 Study of MRT-2359 + Apalutamide in Patients with AR Mutation-Positive Metastatic CRPC

SUPRAME topline data disclosure for the final PFS analysis expected in H1 2027, followed by BLA submission in 2027

Enrollment opens in Ph 1 Clinical Trial Evaluating Treatment of Malignant Brain Tumors with APTN-101

Business news

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

AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in LBCL

Akiram Therapeutics and ITM Sign Lutetium-177 Supply Agreement to Support Development of AKIR001 for the Treatment of Solid Tumors

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