Malignant solid neoplasm, ERBB3-mutated

1 regimens on this page 1 variants on this page

All lines of therapy

Neratinib monotherapy

Regimen

Study	Evidence
Hyman et al. 2018 (SUMMITHER)	Non-randomized basket trial, fewer than 20 pts in this subgroup

Note: the cycle length is not described in the manuscript; the authors have clarified that the cycles are 28 days in length. This trial should not be confused with the one by the same name in multiple myeloma.

Biomarker eligibility criteria

• Gene: HER3
• Alteration: various substitutions
• Acceptable methods of measurement: next-generation sequencing assay or RT-PCR, Sanger, pyrosequencing, or mass spectrometry-based sequencing methods

Prior treatment criteria

• No prior treatment with HER kinase inhibitors

Targeted therapy

• Neratinib (Nerlynx) 240 mg PO once per day on days 1 to 28

Supportive therapy

• Loperamide (Imodium) (dose not specified) mandatory during cycle 1

28-day cycles

References

1. SUMMIT: Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler RE Jr, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature. 2018 Feb 8;554(7691):189-194. Epub 2018 Jan 31. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01953926