Puma's Nerlynx Edges Out Novartis' Tykerb in Breast Cancer Trial

Breast cancer cell illustration

Ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting, Puma Biotechnology presented a meeting abstract. In it, the company’s Nerlynx (neratinib), in combination with Roche’s chemotherapy drug Xeloda (capecitabine), was compared to Novartis’ Tykerb (lapatinib) and Xeloda in breast cancer. The Nerlynx-Xeloda combination showed a treatment advantage.

The NALA clinical trial is a multinational, randomized, open-label, Phase III trial in patients with stage IV HER2+ metastatic breast cancer who had received two or more previous HER2-directed treatments. Patients were randomized 1:1 to receive Nerlynx and Xeloda or Tykerb and Xeloda. Co-primary endpoints were progression-free survival (PFS) and overall survival (OS).

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Secondary endpoints were investigator-assessed PFS, objective response rate (ORR), duration of response (DoR), clinical benefit rate (CBR); time to intervention for symptomatic metastatic central nervous system (CNS) disease, safety, and patient-reported health outcomes.

The trial evaluated 621 patients. PFS for the Nerlynx-Xeloda cohort at 6 and 12 months were 47% and 38%, respectively. For the Tykerb-Xeloda cohort, the PFS at 6 and 12 months were 29% and 15%, respectively.

In addition, overall survival at the same time points was higher for the Nerlynx-Xeloda group, 33% compared to 27% for the Tykerb-Xeloda group, but that wasn’t statistically significant.

Tolerability was similar between the two cohorts and no new safety signals were observed.

Nerlynx is Puma’s first commercial product. At the company’s May 9 first-quarter financial report, Puma noted that all sales revenue for the quarter came from Nerlynx, which brought in $45.6 million, compared to net revenue for the drug in the first quarter of 2018 of $36 million. The company reported a net loss for the quarter of $10.1 million, or $0.26 per share, for the quarter. Non-GAAP adjusted net income was $8.1 million, or $0.21 per basic share and $0.20 per diluted share, for the quarter.

“Puma experienced lower than expected net product revenue in the first quarter of 2019,” stated Alan H. Auerbach, chairman, chief executive officer and president of Puma. “This reduction in net revenues was the result of an increase in expenses charged against gross revenue for the quarter. Additionally, net product revenue declined in the quarter as a result of an increase in patients discontinuing treatment with Nerlynx.”

Nonetheless, the company expects to file a new drug application (NDA) for Nerlynx based on data from the Phase III trial in third-line metastatic breast cancer this summer, meet with the U.S. Food and Drug Administration (FDA) this summer to discuss the clinical development and regulatory strategy for the SUMMIT clinical trial, and is expecting regulatory decisions for the extended adjuvant HER2+ early stage breast cancer indication in other countries in the second half of this year. It also expects to report more data from the Phase II CONTROL trial soon and Phase II data from the SUMMIT basket trial in patients with HER2 mutations in the second half of the year.

Nerlynx is a once-daily oral drug indicated for patients who finished Herceptin (trastuzumab) therapy after surgery for early-stage breast cancer. The drug is a kinase inhibitor.

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