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TOP STORIES from the week

Subcutaneous RYBREVANT (amivantamab) demonstrates 77% ORR in 1L treatment of patients with certain types of advanced head and neck cancer

Novocure enters clinical trial collaboration and supply agreement with Verastem Oncology to evaluate TTFields therapy, chemo and VS-7375 to treat pancreatic cancer

Updated data announced from Cohort 4 of Ph 1/2 GOBLET study of pelareorep + Tecentriq in 2L+ SCAC patients

BLA for Etentamig submitted to US FDA for RRMM patients

Dren Bio Announces $350 Million Financing to Advance Dibotatug Toward Commercialization and Accelerate Development of Broader Pipeline

European Commission approves TECVAYLI (teclistamab) monotherapy for relapsed/refractory multiple myeloma

FDA approves clinical trials under IND application for FMC-242 in solid tumors

Updated data announced from Cohort 4 of Ph 1/2 GOBLET study of pelareorep + Tecentriq in 2L+ SCAC patients

First Patients enrolled in Standard of Care Chemo Combination Cohorts of Global Ph 1/2 ASCEND Trial of CR-001

Dren Bio Announces $350 Million Financing to Advance Dibotatug Toward Commercialization and Accelerate Development of Broader Pipeline

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Drug approvals

Enhertu approved in the EU as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer

FDA approves TALZENNA plus XTANDI for HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer

European Commission approves TECVAYLI (teclistamab) monotherapy for relapsed/refractory multiple myeloma

FDA grants traditional approval for Keytruda or Keytruda Qlex for unresectable or metastatic TMB-H solid tumors with updated indication

Regulatory news

BLA for Etentamig submitted to US FDA for RRMM patients

FDA approves clinical trials under IND application for FMC-242 in solid tumors

FDA approves the investigator-sponsored clinical trial (IST) of HMBD-002 in combination with venetoclax and azacitidine in AML and MDS

FDA provides Feedback in Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

Trial results

Subcutaneous RYBREVANT (amivantamab) demonstrates 77% ORR in 1L treatment of patients with certain types of advanced head and neck cancer

Updated data announced from Cohort 4 of Ph 1/2 GOBLET study of pelareorep + Tecentriq in 2L+ SCAC patients

Ph 3 LiGeR-HN1 trial of Petosemtamab + pembrolizumab versus pembrolizumab alone met both primary endpoints in PD-L1 positive HNSCC patients 

Positive Results from Ph 2 BELLA Trial of Lifyorli, Nab-Paclitaxel and Bevacizumab in Patients with Platinum-Resistant Ovarian Cancer Reported

trial status

First Patient Dosed in Ph 1 Trial of UGN-501 for NMIBC

Ph 3 IMpactMF trial of imetelstat in JAK inhibitor R/R myelofibrosis to be discontinued based on DMC recommendation

First Patient dosed in Ph 3 RASolve 308 Trial of Zoldonrasib + Pembrolizumab and Chemo in 1L Metastatic RAS G12D Non-Squamous NSCLC

First Patients enrolled in Standard of Care Chemo Combination Cohorts of Global Ph 1/2 ASCEND Trial of CR-001

Business news

Novocure enters clinical trial collaboration and supply agreement with Verastem Oncology to evaluate TTFields therapy, chemo and VS-7375 to treat pancreatic cancer

Dren Bio Announces $350 Million Financing to Advance Dibotatug Toward Commercialization and Accelerate Development of Broader Pipeline

Astellas and Audax Biosciences Enter Exclusive Option and License Agreement for DAX-044

Starton Therapeutics Signs Clinical Trial Agreement with the Stanford School of Medicine to Evaluate STAR-LLD Combo with Novel CAR-T for Multiple Myeloma

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