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TOP STORIES from the week

Ipsen to acquire Kartos Therapeutics, expanding hemato-oncology late-stage pipeline

Excalipoint Therapeutics Announces Clinical Trial Collaboration with Roche to Evaluate EXP011 in DLL3‑Expressing Solid Tumors

Positive Ph 3 Results for BRUKINSA in Frontline MCL Announced

Novartis to acquire Myricx Bio for ADCs with N-myristoyltransferase inhibitor (NMTi) payloads

Positive Ph 3 Results for Epcoritamab + Lenalidomide in R/R DLBCL Patients Demonstrated Statistically Significant PFS Improvement

Enhertu approved in the EU for patients with previously treated HER2+ve metastatic solid tumours

Datroway recommended for approval in the EU by CHMP for patients with 1L metastatic TNBC who are not candidates for immunotherapy

Positive Ph 3 Results for Epcoritamab + Lenalidomide in R/R DLBCL Patients Demonstrated Statistically Significant PFS Improvement

First patient dosed in RASolute 305 Ph 3 Trial of Zoldonrasib-Chemo combo in 1L RAS G12D Metastatic Pancreatic Cancer 

Excalipoint Therapeutics Announces Clinical Trial Collaboration with Roche to Evaluate EXP011 in DLL3‑Expressing Solid Tumors

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Drug approvals

TEPKINLY (epcoritamab) in Combination with Lenalidomide & Rituximab Approved by the European Commission for the Treatment of R/R Follicular Lymphoma

FDA Approves KEYTRUDA and KEYTRUDA QLEX each with Trodelvy as 1L Treatment of PD-L1+ (CPS ≥10) Advanced TNBC

Enhertu approved in the EU for patients with previously treated HER2+ve metastatic solid tumours

NMPA approves satricabtagene autoleucel for treating 3L+ Claudin18.2+ve, HER2-neg advanced G/GEJA

Regulatory news

HETRONIFLY (serplulimab) recommended by the NICE for routine use within the NHS in England and Wales

FDA Alignment to Advance ProstACT Global Ph 3 Trial

FDA Accepts RP1 BLA Resubmission for Advanced Melanoma

Datroway recommended for approval in the EU by CHMP for patients with 1L metastatic TNBC who are not candidates for immunotherapy

Trial results

Positive Ph 3 Results for BRUKINSA in Frontline MCL Announced

Positive Ph 3 Results for Epcoritamab + Lenalidomide in R/R DLBCL Patients Demonstrated Statistically Significant PFS Improvement

Positive Interim Ph 1 Advanced Cancer Study Data Demonstrating Long-Term Safety and Tolerability of PAS-004, and Durable Clinical Activity in MEK/BRAF-Pretreated Patients, plus Protocol Expansion Announced

Results From the eNRGy Trial of Zenocutuzumab in Patients with NRG1+ Cholangiocarcinoma published in Journal of Clinical Oncology (JCO)

trial status

CAR001 Ph 1 safety validation completed and Ph IIa solid tumor market trial initiated 

Ph 3 AURORA Trial of Aglatimagene Besadenovec (CAN-2409) in Advanced NSCLC Patients with Inadequate Response to Immune Checkpoint Inhibitors initiated

Independent DMC recommended continuation of Ph 3 OVATION 3 trial of IMNN-001 + SOC neoadjuvant and adjuvant chemo in 1L ovarian cancer

First patient dosed in RASolute 305 Ph 3 Trial of Zoldonrasib-Chemo combo in 1L RAS G12D Metastatic Pancreatic Cancer 

Business news

Ipsen to acquire Kartos Therapeutics, expanding hemato-oncology late-stage pipeline

Excalipoint Therapeutics Announces Clinical Trial Collaboration with Roche to Evaluate EXP011 in DLL3‑Expressing Solid Tumors

Novartis to acquire Myricx Bio for ADCs with N-myristoyltransferase inhibitor (NMTi) payloads

Pyxis Oncology Announces Up to $114M Private Placement Financing to Advance MICVO Through Key Clinical Milestones

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