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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65 year-old Jenny was diagnosed with triple-positive breast cancer in 2017. After completing radiotherapy, chemotherapy and HER 2 targeted therapies, she was enrolled in a NERLYNX® trial program. Click on the image banner above to play the video.
Cath Griffiths has been an oncology nurse for almost 30 years and has extensive experience in managing breast cancer patients who have been taking NERLYNX within trial programs. In this piece, she provides her advice on optimal patient management. Click on the image banner above to play the video.
47-year-old mother-of-two Kate Harper was diagnosed with HER2+ breast cancer in 2017. Following chemotherapy and trastuzumab-based therapy, she has commenced NERLYNX therapy. She has continued working throughout her treatment. Click on the image banner above to play the video.
When the ExteNET study was undertaken, researchers did not provide prophylactic anti-diarrhoeal medications to those patients enrolled, despite neratinib being a TKI absorbed through the bowel.
The CONTROL trial is an open label Phase 2 study investigating whether the incidence and severity of diarrhoea can be reduced in patients with early-stage HER2+ breast via prophylactic management.
Professor Arlene Chan has enrolled more than 50 patients in this study and in this piece, discusses the trial and her anecdotal findings prior to full publication.