|The following article features coverage from the Society of Gynecologic Oncology’s 50th Annual Meeting on Women’s Cancer. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
An updated interim efficacy analysis of data from the ongoing Neratinib HER Mutation Basket Study (SUMMIT; ClinicalTrials.gov Identifier: NCT01953926) revealed a clinical benefit rate (CBR) of 67% for the subcohort of women with metastatic HER2-positive cervical cancer treated with neratinib. The findings from this study were presented at the Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer.
The SUMMIT trial is an open-label, non-randomized, multinational phase 2 study of the efficacy and safety of neratinib alone or in combination with other therapies for patients with solid tumors that are characterized by an ERBB mutation or EGFR gene amplification. Included in SUMMIT is a subgroup of women with metastatic HER2-positive cervical cancer receiving 240 mg once daily doses of single-agent neratinib, an oral, irreversible pan-HER tyrosine kinase.
As of August 17, 2018, 9 of the patients in this subgroup were considered eligible for an efficacy analysis. Of these patients, most had HER2 S310F/Y mutations (6 patients), the remaining patients had HER2 mutations characterized as G776V (1patient), R678Q (1 patient), or D769N (1 patient). In addition, 8 and 1 patient(s) had disease characterized by adenocarcinoma and squamous cell carcinoma histology, respectively. The median number of prior treatments was 2, with 100% and 67% of patients receiving prior treatment with platinum-based chemotherapy and bevacizumab, respectively.
Treatment efficacy was determined by RECIST 1.1 and/or PET response criteria. Four patients achieved a confirmed objective response, with 1 complete response (CR), for an overall response rate of 44%. Two patients (22%) achieved stable disease. Median progression-free survival was 8 months.
Diarrhea was the most commonly reported adverse event, with 1 patient experiencing grade 3 diarrhea, however no patients discontinued neratinib treatment due to diarrhea. In addition, no new safety signals were observed for neratinib in this subgroup of patients.
Read more of Cancer Therapy Advisor‘s coverage of SGO’s annual meeting by visiting the conference page.
- D’Souza A, Roman LD, Saura C, et al. Neratinib in patients with HER2-mutant, metastatic cervical cancer: findings from the phase 2 SUMMIT ‘basket’ trial. Presented at: the Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer, Honolulu, Hawaii; March 16-19, 2019. Abstract 18.