Puma Biotechnology received an update on the development program for its HER2-targeted drug neratinib (Nerlynx) on the third day of the 38th annual JP Morgan Healthcare Conference, while Natera addressed the application of its Signatera genetic test to precision oncology trials. Below are short updates on the presentations that our staff will cover at the conference and at our New York offices.
Alan Auerbach, CEO of Puma Biotechnology, addressed the development of neratinib (Nerlynx), that the company has been investigating for various tumor types with HER2, HER3 or EGFR mutations or with EGFR gene amplification in the Phase II SUMMIT basket trial. The medication has already been licensed by the U.S. Food and Drug Administration and has the European Commission’s marketing authorisation for extended early-stage adjuvant, HER2-positive breast cancer treatment following adjuvant trastuzumab-based therapy.
He also tackled the high neratinib discontinuation levels due to diarrhea. Nearly 40 percent of patients had grade 3 or more severe diarrhea in the Phase III study which led to approval of the medication, and about 17 percent terminated the trial due to this adverse event.
Given this side effect, Auerbach acknowledged that neratinib has an advantage over other HER2-targeted drugs, since it can cross the blood brain barrier. This advantage was apparent in the Phase III NALA trial, which matched neratinib and chemotherapy capecitabine (Genentech’s Xeloda) to lapatinib (Novartis ‘ Tykerb) plus third line metastatic breast cancer capecitabine HER2-positive.
In addition, Auerbach spoke about success in the SUMMIT basket trials targeting tumors with EGFR exon 18, HER2 or HER4 mutations. The nature of the study provides for an extension of the cohort to 18 patients if at least one of the first seven enrolled patients react to the therapy.
Auerbach said the population for breast cancer affected by HER2 would be extended. Puma plans to obtain accelerated approval for the hormone receptor-positive / HER2-negative, and HER2-mutated metastatic breast cancer cohort.
Puma is also conducting a study in which researchers are examining metastatic breast and cervical cancer patients with somatic HER2 mutations in their blood using the Alman HER-Seq Assay Kit. In the procedure, patients are eligible for trial periods of three to six months to track them for progression
Natera CEO Steve Chapman addressed the firm’s oncology-based cell-free DNA testing business, including the launch of a new clinical trial for its Signatera assay to control colorectal cancer and check residual disease. AstraZeneca funds the trial, called COLUMBIA-2,.
Chapman said the study is noteworthy because it is the first time that the primary endpoint of a procedure, as assessed by Signatera, will be clearance of circulating tumor DNA after six months of treatment.