Samuraciclib

Samuraciclib Shows Promise in HR+ Breast Cancer Patients Without TP53 Mutations or Liver Metastases

7 days ago

• Carrick Therapeutics' CDK7 inhibitor samuraciclib demonstrated significantly extended progression-free survival in HR+ advanced breast cancer patients without TP53 mutations or liver metastases in two independent Phase 2 trials. • Patients without TP53 mutations showed median progression-free survival of 14.2 and 7.4 months across two trials, compared to just 1.8 months for patients with these mutations. • The biomarker-driven approach could provide a new treatment option for patients who develop resistance to standard CDK4/6 inhibitor therapy, with Phase 3 trials planned for 2026.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Robust Clinical Trial Pipeline Fuels Hope for Renal and Breast Cancer Advances

8 months ago

• The renal cancer clinical trial pipeline is robust, with over 70 companies developing more than 75 therapies, including novel immunotherapies and targeted agents. • Breast cancer research is also thriving, with over 100 companies exploring 120+ new drugs, such as antibody-drug conjugates and PARP inhibitors, in clinical trials. • Recent FDA actions, including Fast Track and Breakthrough Therapy designations, highlight the potential of emerging therapies for both renal and breast cancer. • Advances in diagnostics, such as PET imaging agents for clear cell renal cell carcinoma, are also contributing to improved management of these diseases.

Carrick Therapeutics Initiates Phase 1 Trial of Novel CDK12/13 Inhibitor CT7439 in Advanced Solid Tumors

8 months ago

• Carrick Therapeutics has dosed the first patient in a Phase 1 clinical trial of CT7439, a novel CDK12/13 inhibitor and Cyclin-K glue-degrader. • The Phase 1 trial will assess the safety, pharmacokinetics, and early proof of principle of CT7439 in patients with advanced solid tumors. • CT7439's dual mechanism of action targets DNA repair at the transcriptional level, potentially synergizing with PARP inhibitors in various cancers. • This trial marks the advancement of Carrick Therapeutics' second therapeutic into clinical development for aggressive and resistant cancers.

Samuraciclib Shows Promise in Advanced Breast Cancer Patients After CDK4/6 Inhibitor Failure

2 years ago

• Phase I clinical trials demonstrate samuraciclib, a selective CDK7 inhibitor, has an acceptable safety profile with manageable gastrointestinal side effects and shows clinical activity in various advanced solid tumors. • In HR+/HER2- breast cancer patients who progressed on CDK4/6 inhibitors, the combination of samuraciclib with fulvestrant achieved a clinical benefit rate of 36% and median progression-free survival of 3.7 months. • Exploratory analysis revealed patients without TP53 mutations had significantly longer progression-free survival (7.4 months vs 1.8 months), suggesting TP53 status may serve as a potential biomarker for treatment response.

Samuraciclib Plus Fulvestrant Shows Promising Results in Heavily Pretreated HR+ Breast Cancer

3 years ago

• The CDK7 inhibitor samuraciclib combined with fulvestrant demonstrated 72% tumor shrinkage rate in hormone receptor-positive breast cancer patients previously treated with CDK4/6 inhibitors. • TP53 mutational status emerged as a significant biomarker, with wild-type patients achieving median progression-free survival of 32 weeks compared to just 7.9 weeks in those with TP53 mutations. • Patients without liver metastases showed particularly strong responses, with progression-free survival exceeding 48 weeks, suggesting potential for targeted treatment strategies in specific patient populations.

Advanced Drug Monograph