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Strata Oncology to Aid Puma Biotech in Recruiting for Neratinib HER2 Basket Study

NEW YORK (GenomeWeb) – Puma Biotechnology and Strata Oncology said today that they have entered a collaboration aimed at accelerating patient enrollment in Puma's ongoing Phase II SUMMIT trial of PB272 (neratinib).

The SUMMIT trial is a multi-histology basket study evaluating the safety and efficacy of neratinib in patients with a wide variety of solid tumors that are characterized by activating mutations in EGFR, HER2, or HER4. Neratinib is already approved by the US Food and Drug Administration for the extended adjuvant treatment of early-stage HER2-positive breast cancer and marketed in the United States as Nerlynx. But data has shown more recently that the drug has activity across multiple tumor types with HER2-activating mutations.

Under the terms of the new agreement, Strata will exclusively refer advanced cancer patients with HER2 mutations, identified through what it calls its "Strata Trial" screening protocol, for potential enrollment in SUMMIT. Comprehensive tumor molecular profiling through the Strata Trial is available to advanced cancer patients across the Strata Precision Oncology Network — which currently includes 11 health systems — under a unique model wherein Strata provides free testing to patients and then charges pharmaceutical companies for access to the resulting data.

In addition to the new deal with Puma, Strata has publicized partnerships with several other pharmaceutical companies, including Clovis Oncology and Epizyme.

"We frequently identify HER2-mutant patients across the Strata Precision Oncology Network and we believe this partnership will greatly facilitate patient access to this promising clinical trial," Strata CEO Dan Rhodes said in a statement.

Financial terms of the agreement were not disclosed.