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Author: Admin | 2025-04-28
Is really consistent, regardless of the subgroups that are evaluated,” Dana Kennedy, Pfizer’s genitourinary cancers development head, said in an interview with Fierce Pharma. “We see that median [overall survival] around 45 months in our gene-altered patients, as well as those patients who lack HRR gene alterations.” Related PARP inhibitors have historically been able to show some tumor progression benefits, but these benefits haven’t always translated into longer patient life spans thanks in part to nasty side effects. In TALAPRO-2, treatment-related serious adverse events were notably more frequent, at 21.4%, in the Talzenna-Xtandi arm than the 3.2% rate seen in the Xtandi group. Anemia was the most common treatment-emergent adverse event, with rates of 67.8% and 20%, respectively, in the two arms.Anemia is not a cumulative toxicity for the combo, Kennedy noted. Cases typically arose early in the course of treatment, and patients were mostly able to stay on treatment with dose modifications or interruptions. All told, 21.6% of patients discontinued Talzenna due to any adverse events in the combo arm, including a fewer than 10% rate of discontinuations from anemia, according to Kennedy.The other concern for Pfizer is whether doctors will paint all PARP inhibitors with the same brush. Back in 2023, the FDA gave Johnson & Johnson’s Akeega—a fixed tablet of GSK’s PARP inhibitor Zejula and J&J’s Zytiga—and AstraZeneca and Merck’s Lynparza-Zytiga cocktail separate approvals that limit their mCRPC uses to BRCA mutations only.In addition, in ovarian cancer, the largest market for PARP inhibitors, cases with BRCA mutations are driving the majority of PARP adoption despite the larger non-BRCA-mutated patient base.Kennedy acknowledged that the other two PARP drugs’ results might impact the scientific community’s view of Talzenna. But she argued that Pfizer’s data set is differentiated because it’s the only one that now boasts an overall survival win
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