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Tsucatinib added to primary maintenance during investigation of HER2 + metastatic breast cancer

The addition of tucatinib to the maintenance of standard of care in the first-line setting of patients with HER2-positive metastatic breast cancer will be considered in the ongoing Phase 3 HER2 CLIMB-05 trial.

The addition of tsucatinib (Tuxa) to the standard of care maintenance therapy consisting of trastuzumab (Herceptin) and pertuzumab (Perjeta) in the first line of patients with HER2-positive metastatic breast cancer will be considered in ongoing Phase 3 HER2 CLIMB-05. The study, according to a poster presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

Additional goals for this study include assessment of antitumor activity, overall survival, and safety and tolerability of the combination of treatments.

“Adding Tsukachinib to the first line [standard of care] Maintenance therapy with trastuzumab and pertuzumab may prolong PFS while maintaining quality of life. In patients with brain metastases, tucatinib has shown the ability to improve PFS, OS, and / or delay the appearance of brain metastases. Therefore, it is believed that patients in the front-line setting may also benefit from the administration of tucatinib, “said the Sara Cannon Institute’s Breast Cancer and Gynecology Research Program at Tennessee Oncology, Nashville. The research author, Tennessee, led by Dr. Erica Hamilton’s director, wrote on their poster.

To enroll, patients centrally identify HER2-positive breast cancer, unresectable locally advanced or metastatic disease, and receive 4-8 cycles of previous treatment with trastuzumab and pertuzumab in first-line treatment with no evidence of disease progression. Must be. Additional criteria include known hormone receptor status, 0 or 1 ECOG performance status, and no evidence of brain metastases, no evidence of progression, asymptomatic, untreated brain metastases, or asymptomatic progression. Since any of the previously treated brain metastases that have not included treatment.

Exclusion criteria consisted of pretreatment with anti-HER2 and / or anti-EGFR tyrosine kinase inhibitors and the inability to undergo contrast-enhanced MRI of the brain. CNS exclusion criteria consisted of symptomatic brain metastases, brain metastases that progressed after the start of front-line treatment, and continued use of corticosteroids with daily doses of dexamethasone greater than 2 mg. I did.

After complete induction of 4-8 cycles with trastuzumab / pertuzumab and taxane therapy, approximately 650 patients were randomized 1: 1 with 300 mg oral tuzumab twice daily or trastuzumab continuous with placebo. / Use with pertuzumab. Instead of receiving trastuzumab and pertuzumab separately, patients may also be given subcutaneous pertuzumab, trastuzumab, and hyaluronidase-zzxf (Fesgo).

Time to worsen HRQOL is the time it takes for the European Cancer Research and Treatment Organization (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) to reduce global health / QOL scale by 10 points. It is defined. .. While assessing safety, researchers examine side effects, laboratory evaluations, and the frequency of dose retention, dose reduction, and treatment discontinuation.

Exploratory objectives outlined in the presentation include identifying somatic changes associated with resistance to tsucatinib, assessing health utilities with the EuroQol-5 Dimension 5 Level (EQ-5D-5L) questionnaire, and worldwide. EORTCQLQ-C30 scale that includes assessment of health status and physical and role function.

reference

Hamilton EP, O’Sullivan C, Martin M, etc. Phase 3 study of trastuzumab and pertuzumab in combination with trastuzumab and placebo as maintenance therapy for HER2 + metastatic breast cancer (HER2CLIMB-05, under study). J Clin Oncol.. 2022; 40 (suppl 16): TPS1108. Doi: 10.1200 / JCO.2022.40.16_suppl.TPS1108

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Tsucatinib added to primary maintenance during investigation of HER2 + metastatic breast cancer

reference