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TOP STORIES from the week

Antares Therapeutics Enters Agreement with Novartis to Discover, Develop and Commercialize First-in-Class Cancer Therapies

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

VS-7375 Demonstrates Clinical Activity with a Favorable Safety and Tolerability Profile in TARGET-D 101 Ph 1/2 Trial in Patients with Advanced KRAS G12D-Mutated Solid Tumors

FDA Accepts RP1 BLA Resubmission for Advanced Melanoma

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

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

FAILED TRIAL: Ph 3 SigVie-002/Be6A Lung-01 trial of sigvotatug vedotin in 2L+ NSCLC did not show a statistically significant OS improvement vs docetaxel

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

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

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Drug approvals

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

EC Approves KEYTRUDA + Padcev for Adults With Cisplatin-Ineligible Resectable MIBC

Regulatory news

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

NDA submitted in Japan for Zepzelca (lurbinectedin) in 1L maintenance therapy in SCLC

BfArM Approval to Initiate Ph 2/3 Trial of SIL204 in Locally Advanced Pancreatic Cancer

Trial results

VS-7375 Demonstrates Clinical Activity with a Favorable Safety and Tolerability Profile in TARGET-D 101 Ph 1/2 Trial in Patients with Advanced KRAS G12D-Mutated Solid Tumors

FAILED TRIAL: Ph 3 SigVie-002/Be6A Lung-01 trial of sigvotatug vedotin in 2L+ NSCLC did not show a statistically significant OS improvement vs docetaxel

Positive Ph 1b Data with GNS561 in Combination Therapy in Heavily Pretreated Patients with Cholangiocarcinoma Announced

FAILED TRIAL: Ph 2 DOVACC study evaluating UV1 in BRCAwt platinum sensitive recurrent ovarian cancer did not meet primary endpoint of PFS improvement

trial status

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 

Eleven sites open for patient enrollment in TakeAim CLL combination study with zanubrutinib

First Patient enrolled in Ph 1/2 Trial Evaluating PM54 Plus Pembrolizumab in Advanced Solid Tumors

Business news

Antares Therapeutics Enters Agreement with Novartis to Discover, Develop and Commercialize First-in-Class Cancer Therapies

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

Siren Biotechnology Awarded $8M in Non-Dilutive Grant Funding from CIRM to Support Clinical Development of SRN-101 in High-Grade Glioma

Natera and Aveta Biomics Announce Strategic Partnership Supporting Global Ph 3 Registrational Trial of APG-157 in Head and Neck Cancer

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