pirotinib (KBP-5209) / Sihuan Pharmaceutical - LARVOL DELTA

Multicenter real-world study of trastuzumab combined with pirotinib or pertuzumab as a neoadjuvant therapy for stage II-III HER-2 positive breast cancer. (ASCO 2025) - "In recent years, multiple studies have revealed that the combination of Trastuzumab and Pyrotinib (HPy) has satisfactory efficacy and controllable toxic side effects. In the real-world study, HER-2 positive early breast cancer patients are more likely to use HP as neoadjuvant therapy, and HP are more likely to be used in combination with platinum drugs. Our study has confirmed that there is no significant difference in tpCR rates between HPy or HP."

Clinical • Real-world • Real-world evidence • Anemia • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Oncology • Solid Tumor • HER-2

PYTHON: Preoperative Treatment of HR+/HER2+Breast Cancer With Pirotinib, Trastuzumab and AI Research (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

A phase I study of the tolerability, safety, pharmacokinetics and preliminary antitumor effects of KBP-5209, a novel pan-HER inhibitor, in patients with advanced solid tumors. (ASCO 2017) - P1; "Based on the present data, KBP-5209 has been well tolerated with a safety profile similar to other pan-HER inhibitors. For QD dosing, maximum tolerated dose has been identified as 70mg QD. The BID dose escalation continues."

Adverse events • P1 data • Serious adverse event • Biosimilar • Colorectal Cancer • Gastric Cancer • Non Small Cell Lung Cancer • Sarcoma

A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Sihuan Pharmaceutical Holdings Group Ltd. | Recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

[VIRTUAL] Studies on the efficacy of pyrotinib in the treatment of HER-2 positive advanced solid tumors. (ASCO 2020) - "11 cases of trastuzumab were changed to anti-HER-2 after treatment failure, of which 2 cases were treated with pirotinib after trastuzumab and lapatinib failed treatment...The common symptoms were diarrhea (100%), hand and foot skin reaction (38%), rash (8%), etc. Grade 3 to 4 adverse events occurred in 1 patient (8%) received pyrotinib plus capecitabine...The treatment of HER-2 positive advanced solid tumors with pyrotinib have good exact affect, and the toxicity could be controlled. Research Funding: None"

Clinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2