Adam M. Brufsky, MD, PhD Speaking at the Singapore Society of Oncology July 2022 on ‘Available Therapeutic Options for the Management of HER2-Positive Metastatic Breast Cancer: 2nd Line and Beyond’.
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NALA was a multi-national, randomised, open-label Phase 3 trial of NERLYNX (neratinib)/capecitabine versus lapatinib/capecitabine in patients with HER2+ mBC who had received more than 2 prior lines of HER2-directed therapy. Investigators found that the NERLYNX/capecitabine cohort had significantly improved PFS and importantly, there was a significant delay in the onset and progression of brain metastases in the NERLYNX treated patients.
Abstract link: https://abstracts.asco.org/239/AbstView_239_262265.html
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The Phase 2 CONTROL study is an international, open-label, sequential-cohort, Phase 2 study investigating the effects of loperamide prophylaxis alone or with add-on budesonide, a locally-acting corticosteroid used for inflammatory gastrointestinal conditions, or colestipol, a bile acid sequestrant, on NERLYNX-associated diarrhoea. Investigators have found that the addition of budesonide or colestipol to loperamide prophylaxis given for 1-2 cycles reduces the severity and duration of diarrhoea in patients treated with NERLYNX, improving tolerability. The initial data suggests that the benefits appear even greater in the dose escalation cohort, although this cohort is yet to complete enrolment.
Abstract link: https://abstracts.asco.org/239/AbstView_239_265427.html
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Patients whose adverse affects are appropriately managed and remain on NERLYNX for longer stand to gain the most benefit. That was the top-line message from a further analysis of the pivotal phase 3 ExteNET study, according to Puma Biotechnology Medical Director Dr Brian Barnett at ASCO 2018.
Here he discusses the CONTROL study and optimal strategies for mitigating adverse events associated with NERLYNX.
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NERLYNX and the Phase 3 ExteNET study were the focus of key presentations at ASCO 2018. New York Medical Oncologist Francis Arena MD provided the following insights.
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Breast cancer patients with HER2+/HR- tumours can still benefit from neratinib therapy, provided treatment is initiated within 6 months of trastuzumab therapy. We spoke with Dr Bent Ejlertsen from the Rigshospitalet, Copenhagen at ASCO 2018.
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