While European regulators appear ready to slap down Puma Biotechnology’s $PBYI first shot at an approval for Nerlynx (neratinib), the company is pushing ahead with a basket trial it hopes to use to eventually use to broaden its initial FDA approval for breast cancer to a whole range of solid tumors.
In the first cut of the SUMMIT study, researchers say they noted that “responses were observed in patients with breast, cervical, biliary, salivary and non-small-cell lung cancers, which led to cohort expansions in these tumor types. No activity was observed in the HER3-mutant cohort.”
Rather than mount an individual study on each cancer type, Puma is pursuing a basket design that groups together patients with different types of cancers to see how their drug can be more rapidly accelerated to each, or where they should avoid going.
“SUMMIT is also significant in that it will provide the largest body of clinical data to date on the use of an irreversible pan-HER inhibitor in patients who have solid tumors with somatic HER2 or HER3 mutations,” says CEO Alan Auerbach.
The CHMP, though, has raised concerns about the clinical relevance of the data Puma gathered in their first Phase III study.
Nerlynx is also linked to a high rate of serious diarrhea, which didn’t prevent a lopsided vote in its favor by a group of expert FDA advisers, who appeared satisfied that the side effect could usually be controlled with daily doses of loperamide.
Even so, in the SUMMIT trial “four patients (2.8%) permanently discontinued neratinib and 21 patients (14.9%) had dose interruptions due to diarrhea.”
In the meantime, analysts are watching for a new round of Phase III data that should be coming up soon. In a recent note, Leerink’s Michael Schmidt said:
This second pivotal Phase III trial of neratinib in the 3rd line metastatic HER2+ breast cancer setting completed patient accrual in mid-17. Top-line results are expected in 1H18. NALA is a double-blind controlled trial comparing Nerlynx combined with capecitabine (Xeloda) vs. Tykerb (lapatinib) combined with Xeloda in 600 patients. The trial is conducted under an SPA agreement with the FDA with the co-primary endpoints being PFS and OS. PBYI plans to submit the NDA and MAA based on the PFS results – if positive.
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