Author: Alsaalamy, Ali Hashiem ; Saleh, Ebraheem Abdu Musad ; S Gilmanova, Nataliya ; Alawady, Ahmed Hussien Radie ; Mamajanov, Nodirjon Akhmetovich ; Ibrahim, Ahmed Jaber ; Ansari, Shakeel Ahmed ; Al-Hawary, Sulieman Ibraheem Shelash ; Alsaab, Hashem O ; Alghamdi, Adel

According to the International Agency for Research on Cancer, breast cancer is more common than lung cancer globally. By 2040, mortality from breast cancer will rise by 50% and 40%, respectively. Despite advances in chemotherapy, endocrine therapy, and HER2-targeted therapy, breast cancer metastases and recurrences remain challenging to treat. Cancer vaccines are an effective treatment option because they stimulate a long-lasting immune response that will eliminate tumor cells. In studies on the breast cancer vaccine, no appreciable advantages were discovered. A recent study claims that immune checkpoint inhibitors or anti-HER2 monoclonal antibodies may be used in vaccinations. This vaccination strengthens the immune system to fight off breast cancer cells. Clinical trials have been conducted on DNA, dendritic cells, and peptide-based breast cancer vaccines. Studies on the breast cancer vaccine have employed subcutaneous, intramuscular, and intradermal injections. Clinical studies have shown that these efforts have not been successful. Several factors might have slowed the development of a breast cancer vaccine. The complexity of the immune system makes it challenging to create cancer vaccines. Given the heterogeneity of breast cancer, there may be a need for different vaccination strategies. Despite these obstacles, research into breast cancer vaccines continues. Effective methods for creating vaccines include immune checkpoint inhibition and anti-HER2 monoclonal antibodies. Research is also being done on specialized tumor vaccinations.

28 Apr 2023·Translational lung cancer research

Activity of osimertinib in a patient with stage IV non-small cell lung cancer harboring HER2 exon 19, p.L755P mutation: case report.

Author: Wood, Samuel ; Furqan, Muhammad ; Jonsdottir, Gudbjorg ; Smith, Mark ; Hejleh, Taher Abu

BackgroundRecurrent in-frame insertions within exon 20 causing duplication of amino acids Tyrosine-Valine-Methionine-Alanine (YVMA) represent 80% of all HER2 alterations in non-small cell lung cancer (NSCLC). HER2 tyrosine kinase inhibitors (TKI), anti-HER2 monoclonal antibodies and HER2 directed antibody-drug conjugates have been evaluated in patients with HER2 mutated NSCLC. Limited data are available regarding the activity of these agents in exon 19 alterations. Osimertinib, a 3rd generation EGFR-TKI, has been found in pre-clinical studies to decrease growth of NSCLC with HER2 exon 19 aberrations.Case DescriptionA 68-year-old female with a past medical history of type 2 diabetes and minimal smoking was diagnosed with stage IV NSCLC. Next generation sequencing on tumor tissue demonstrated an ERBB2 exon 19 c.2262_2264delinsTCC, p.(L755P) mutation. After five lines of treatment that included chemotherapy, chemoimmunotherapy and investigational agents the patient's disease was progressing. At this time her functional status remained good, therefore clinical trials were explored however, none were available. Based on findings from pre-clinical studies, the patient was commenced on osimertinib 80 mg OD and achieved a partial response (PR) according to RESIST criteria both intra- and extracranially.ConclusionsThis is the first report to our knowledge to demonstrate activity of osimertinib in a patient with NSCLC harboring HER2 exon 19, p.L755P mutation resulting in intra- and extracranial response. In the future, osimertinib could become a targeted treatment for patients harboring exon19 ERBB2 point mutations.

01 Feb 2023·JACC: CardioOncology

Pharmacovigilance Analysis of Heart Failure Associated With Anti-HER2 Monotherapies and Combination Regimens for Cancer

Article

Author: Neal, Joel W ; Witteles, Ronald M ; Myall, Nathaniel ; Zhu, Han ; Waliany, Sarah ; Caswell-Jin, Jennifer ; Riaz, Fauzia

BackgroundTrastuzumab improves outcomes in patients with HER2-overexpressing malignancies but is associated with decreases in left ventricular ejection fraction. Heart failure (HF) risks from other anti-HER2 therapies are less clear.ObjectivesUsing World Health Organization pharmacovigilance data, the authors compared HF odds across anti-HER2 regimens.MethodsIn VigiBase, 41,976 patients had adverse drug reactions (ADRs) with anti-HER2 monoclonal antibodies (trastuzumab, n = 16,900; pertuzumab, n = 1,856), antibody-drug conjugates (trastuzumab emtansine [T-DM1], n = 3,983; trastuzumab deruxtecan, n = 947), and tyrosine kinase inhibitors (afatinib, n = 10,424; lapatinib, n = 5,704; neratinib, n = 1,507; tucatinib, n = 655); additionally, 36,052 patients had ADRs with anti-HER2-based combination regimens. Most patients had breast cancer (monotherapies, n = 17,281; combinations, n = 24,095). Outcomes included comparison of HF odds with each monotherapy relative to trastuzumab, within each therapeutic class, and among combination regimens.ResultsOf 16,900 patients with trastuzumab-associated ADRs, 2,034 (12.04%) had HF reports (median time to onset 5.67 months; IQR: 2.85-9.32 months) compared with 1% to 2% with antibody-drug conjugates. Trastuzumab had higher odds of HF reporting relative to other anti-HER2 therapies collectively in the overall cohort (reporting OR [ROR]: 17.37; 99% CI: 14.30-21.10) and breast cancer subgroup (ROR: 17.10; 99% CI: 13.12-22.27). Pertuzumab/T-DM1 had 3.4 times higher odds of HF reporting than T-DM1 monotherapy; tucatinib/trastuzumab/capecitabine had similar odds as tucatinib. Among metastatic breast cancer regimens, HF odds were highest with trastuzumab/pertuzumab/docetaxel (ROR: 1.42; 99% CI: 1.17-1.72) and lowest with lapatinib/capecitabine (ROR: 0.09; 99% CI: 0.04-0.23).ConclusionsTrastuzumab and pertuzumab/T-DM1 had higher odds of HF reporting than other anti-HER2 therapies. These data provide large-scale, real-world insight into which HER2-targeted regimens would benefit from left ventricular ejection fraction monitoring.

100 Deals associated with Fully human internalizing anti-Her2 monoclonal antibodies(A&G Pharmaceutical)

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Preclinical	US	A&G Pharmaceutical, Inc.	16 Apr 2023

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