elgemtumab (LJM-716) / Novartis - LARVOL DELTA

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer (clinicaltrials.gov) - P1; N=23; Completed; Sponsor: Memorial Sloan Kettering Cancer Center; Active, not recruiting ➔ Completed; Trial completion date: Jun 2022 ➔ Jul 2021; Trial primary completion date: Jun 2022 ➔ Jul 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer (clinicaltrials.gov) - P1; N=23; Active, not recruiting; Sponsor: Memorial Sloan Kettering Cancer Center; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Jun 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

A Phase I study of alpelisib in combination with trastuzumab and LJM716 in patients with PIK3CA-mutated HER2-positive metastatic breast cancer. (PubMed, Clin Cancer Res) - "Combination treatment with alpelisib, trastuzumab and LJM716 was limited by gastrointestinal toxicity. Further efforts are warranted to target the PI3K pathway in HER2+ MBC."

Clinical • Combination therapy • Journal • P1 data • Breast Cancer • Diabetes • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Positive Breast Cancer • Mucositis • Oncology • Solid Tumor • HER-2 • PIK3CA

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer (clinicaltrials.gov) - P1; N=23; Active, not recruiting; Sponsor: Memorial Sloan Kettering Cancer Center; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Jun 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

An ERBB1-3 Neutralizing Antibody Mixture With High Activity Against Drug-Resistant HER2+ Breast Cancers With ERBB Ligand Overexpression. (PubMed, J Natl Cancer Inst) - "...HER2+ cell lines and xenografts (n ≥ 6 mice per group) were treated with the ERBB1-3 antibody mixture Pan-HER, trastuzumab/lapatinib (TL), trastuzumab/pertuzumab (TP), or T-DM1...Post-TP and post-T-DM1 recurrent tumors expressed higher levels of neuregulin-1 (NRG1), HER3 and P-HER3 (all P < .05)...These data suggest that upregulation of a NRG1-HER3 axis can mediate escape from anti-HER2 therapies. Further, multitargeted antibody mixtures, such as Pan-HER, can simultaneously remove and/or block targeted ERBB receptor and ligands, thus representing an effective approach against drug-sensitive and -resistant HER2+ cancers."

Journal • Biosimilar • HER2 Breast Cancer

HER3 and its ligand, heregulin, as targets for cancer therapy. (PubMed) - Recent Pat Anticancer Drug Discov - "Concomitantly, the HER3 ligand, heregulin, represents an encouraging candidate biomarker for prediction of the efficacy of HER3-targeting agents. Ongoing clinical trials will address the remaining issues related to optimization of drug combination therapy and improving the targeting of each agent to the most appropriate individuals."

Biomarker • Journal • Biosimilar • Oncology

A phase 1 dose-escalation study of anti-HER3 monoclonal antibody LJM716 in combination with trastuzumab in patients with HER2-overexpressing metastatic breast or gastric cancer (ASCO 2014) - Presentation time: Friday, May 30; 1:00 PM - 4:00 PM; Abstract #2519; P1, N=35; NCT01602406; Sponsor: Novartis; "Of 30 evaluable pts, 2 partial responses (PRs) were observed: 1 each at 3 mg/kg and 10 mg/kg QW (18 and 40 weeks of exposure, respectively)....Six additional pts (17%) with MBC demonstrated minor responses (8-27% tumor shrinkage). Twelve pts (40%) with MBC or MGC had stable disease as the best response (> 16 weeks of exposure in 3 MBC pts)."

P1 data • Biosimilar • Breast Cancer • Gastric Cancer • Oncology

Preparation and identification of single-chain fragment variable against epidermal growth factor receptor 3 (PubMed, Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi) - "Methods We searched NCBI for the light chain sequence and heavy chain sequence of anti-HER3 mAb LJM716 to construct the gene of scFv against HER3. Western blotting showed that the anti-HER3-scFv was correctly expressed and ELISA indicated that anti-HER3-scFv could specifically recognize HER3. Conclusion The anti-HER3-scFv has been successfully prepared."

Journal

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer (clinicaltrials.gov) - P1; N=23; Active, not recruiting; Sponsor: Memorial Sloan Kettering Cancer Center; Trial completion date: Jun 2019 ➔ Jun 2020; Trial primary completion date: Jun 2019 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date