January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Ataraxis AI has launched Ataraxis Breast CTX, an AI test that predicts individualized chemotherapy benefit for breast cancer patients. The tool uses digital pathology and clinical data to estimate patient-level outcomes with and without chemotherapy, moving beyond population averages. The test has been validated across studies involving over 10,000 patients and is now available through CLIA-certified laboratories.
Over 20 pharmaceutical companies are developing therapies for HER2-positive gastric cancer, with multiple Phase III trials launched in March 2026 testing novel combination treatments for advanced disease.
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
Recent research explores plant-based diets' association with breast cancer risk, disparities in care for Black women in Canada, and survival outcomes for young women with breast cancer in Latin America.
The U.S. FDA granted orphan drug designation to HCB101, a next-generation immunotherapy from HanchorBio, for treating gastric cancer including HER2-positive and HER2-negative subtypes.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07059338 |
Dual EGFR/HER2 Blockade Combined With Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT06818773 |
Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer |
NOT_YET_RECRUITING | PHASE4 |
| NCT04152057 |
Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer |
UNKNOWN | PHASE1/PHASE2 |
| NCT02202746 |
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer |
TERMINATED | PHASE2 |
| NCT01996267 |
Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2 |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT01238029 |
Dose Finding Study for Combination of Capecitabine, Lapatinib and Vinorelbine in Metastatic Breast Cancer |
TERMINATED | PHASE1 |
| NCT01226316 |
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules |
COMPLETED | PHASE1 |
| NCT00768859 |
Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study |
COMPLETED | PHASE2 |
| NCT00614978 |
Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer |
COMPLETED | PHASE1 |
