NEW YORK – Allarity Therapeutics on Tuesday said it has scrapped its registrational plans for dovitinib monotherapy in biomarker-selected metastatic kidney cancer patients and is shifting its pipeline focus to combination treatment approaches.
The Cambridge, Massachusetts-based firm made the decision after it met with the US Food and Drug Administration in the second quarter, during which the agency said that before Allarity could move dovitinib into registrational Phase III trials and try its hand at filing another new drug application, it would likely need to conduct a new dosing study. Allarity's board of directors decided that given the costs and delays associated with conducting a new dosing study and the increasingly competitive market in third-line metastatic renal cell carcinoma, advancing dovitinib as a monotherapy would no longer be "commercially viable" or in the best interest of shareholders.
Allarity had been advancing the tyrosine kinase inhibitor dovitinib — originally a Novartis product that failed to outperform Bayer's Nexavar (sorafenib) in head-to-head trials — in kidney cancer patients selected based on gene expression as determined by its DRP-dovitinib test.
Allarity was using a retrospective dataset from the original head-to-head dovitinib-Nexavar trial to try to show dovitinib's non-inferiority to Nexavar in patients with high DRP scores. Based on this analysis, the firm filed a new drug application for dovitinib in the biomarker-selected patient population late last year. Shortly thereafter, however, the FDA sent Allarity a refusal to file letter saying that neither the dovitinib application nor the premarket approval application for the companion diagnostic DRP was complete enough to warrant substantive reviews.
Allarity is still codeveloping dovitinib as a potential monotherapy for pediatric cancers with OncoHeroes Biosciences. Beyond that, the firm is making a strategic shift toward combination therapies in DRP biomarker-selected patient populations.
According to Allarity, its board of directors decided to refocus the pipeline on combination therapies out of a desire to align the firm with where the rest of the precision oncology drug market is headed. The board also believes this shift will improve the company's ability to attract investors, open opportunities to partner with larger drugmakers, and improve its products' chances of reaching the market.
Later this year, Allarity will begin enrolling previously treated ovarian cancer patients to a Phase Ib/II study of its PARP inhibitor stenoparib combined with dovitinib. The firm is also considering combining stenoparib or dovitinib with other therapies and studying them in various tumors, including kidney cancer.
Though the firm is shifting its focus to combination therapies, Allarity said that ongoing monotherapy trials, including for stenoparib for DRP-selected ovarian cancer and Ixempra (ixabepilone) for DRP-selected metastatic breast cancers, will continue until interim data reads out in the fourth quarter of this year and the first quarter of next year, respectively.