Nerlynx (neratinib) vs Truqap (capivasertib)

Nerlynx (neratinib) is an oral tyrosine kinase inhibitor specifically approved for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Truqap (capivasertib) is a selective inhibitor of the AKT serine/threonine kinases, which is under investigation for use in various cancers, including breast cancer, but as of the knowledge cutoff date, it has not been approved for clinical use. When deciding between these medications, it is important to consider the specific type of cancer, the molecular targets, the approval status of the drugs, and to consult with a healthcare provider for personalized advice based on the individual's medical history and the current standard of care.

Difference between Nerlynx and Truqap

Metric	Nerlynx (neratinib)	Truqap (capivasertib)
Generic name	neratinib	capivasertib
Indications	Extended adjuvant treatment of HER2-positive early stage breast cancer	Currently being investigated in clinical trials for various cancers, including breast cancer and prostate cancer
Mechanism of action	Irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2, and HER4	AKT inhibitor that targets the PI3K/AKT signaling pathway
Brand names	Nerlynx	Truqap (investigational, not yet commercially available)
Administrative route	Oral	Oral (in clinical trials)
Side effects	Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT elevation, nail disorders, dry skin, abdominal distention, weight loss, urinary tract infection	Hyperglycemia, rash, diarrhea, fatigue, nausea, decreased appetite, vomiting, stomatitis, dry skin, hypercholesterolemia, hypertension
Contraindications	None known beyond hypersensitivity to neratinib or any of its excipients	Not yet determined, still under investigation
Drug class	Tyrosine kinase inhibitor	AKT inhibitor
Manufacturer	Puma Biotechnology	AstraZeneca (in collaboration with Merck & Co., known as MSD outside the US and Canada)

Efficacy

Nerlynx (neratinib) Efficacy in Breast Cancer

Nerlynx (neratinib) is an oral medication that is used for the treatment of breast cancer. Specifically, it is indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Clinical trials have demonstrated that neratinib can significantly reduce the risk of breast cancer recurrence. The most notable study, the ExteNET trial, showed that neratinib improved invasive disease-free survival (iDFS) when patients were treated following trastuzumab therapy. Patients who received neratinib had a 2-year iDFS rate of 94.2% compared to 91.9% for those who received the placebo, which was a statistically significant improvement.

Despite its efficacy, neratinib is associated with a high incidence of diarrhea, which can be a limiting factor for some patients. However, proactive management strategies, including the use of antidiarrheal prophylaxis, have been shown to be effective in reducing this side effect, allowing patients to benefit from neratinib's efficacy in preventing breast cancer recurrence.

Truqap (capivasertib) Efficacy in Breast Cancer

Truqap (capivasertib) is an investigational drug that targets the AKT pathway, which is known to be involved in the growth and spread of cancer cells. While capivasertib is not yet approved for commercial use, it has shown promise in clinical trials for the treatment of breast cancer. In studies, capivasertib has been used in combination with other cancer therapies, such as fulvestrant, to treat patients with hormone receptor-positive, HER2-negative advanced breast cancer that is also AKT pathway-activated.

One of the key studies evaluating the efficacy of capivasertib is the FAKTION trial. This phase II trial demonstrated that the addition of capivasertib to fulvestrant significantly improved progression-free survival in patients with advanced breast cancer compared to fulvestrant alone. The median progression-free survival was 10.3 months for the combination therapy compared to 4.8 months for the fulvestrant plus placebo group. These results indicate that capivasertib, when used in combination with other therapies, may offer a new treatment option for patients with this subtype of breast cancer.

It is important to note that the information provided here is based on clinical trials and investigational studies. The efficacy of Truqap (capivasertib) in breast cancer will continue to be evaluated in ongoing and future clinical trials to further understand its benefits and risks in the treatment of this disease.

Regulatory Agency Approvals

Nerlynx

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA
Health Canada
Therapeutic Goods Administration (TGA), Australia

Truqap

Food and Drug Administration (FDA), USA

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