Truqap’s positive clinical data comes after it failed a late-stage study in metastatic triple-negative breast cancer. It helps AstraZeneca position itself as a top player in the prostate cancer space, alongside its Big Pharma colleagues.
AstraZeneca on Monday released high-level data from the Phase III CAPItello-281 trial, demonstrating that a combo regimen based on its AKT inhibitor Truqap (apivasertib) significantly boosts radiographic progression-free survival in patients with one type of prostate cancer.
Without providing specific data from the study, AstraZeneca revealed that Truqap plus abiraterone and androgen deprivation therapy (ADT) resulted in a “statistically significant and clinically meaningful improvement” in radiographic progression-free survival (rPFS), versus abiraterone, ADT and placebo. Patients enrolled in CAPItello-281 had PTEN-deficient de novo metastatic hormone-sensitive prostate cancer.
Data for overall survival (OS), a key secondary endpoint of the late-stage study, were still immature at the time of the analysis, though AstraZeneca said there was an “early trend towards an OS improvement” as compared with the control arm. CAPItello-281 will continue to follow patients for OS.
As for safety, the Phase III trial found the Truqap combo to be well-tolerated. Adverse events were broadly consistent with the known toxicity profiles of the individual medicines.
Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said in a statement that Monday’s readout shows “for the first time, that adding an AKT inhibitor to a standard-of-care therapy” can result in clinical benefit for patients with this specific type of prostate cancer.
“By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need,” Galbraith added. AstraZeneca will present the findings at an upcoming medical congress and will share the data with regulatory authorities worldwide, according to its press release.
With Monday’s readout, Truqap redeems itself after its late-stage flop in breast cancer. In June 2024, AstraZeneca announced that the AKT blocker failed the Phase III CAPItello-290 study, as it did not significantly boost OS in patients with metastatic triple-negative breast cancer. The trial, which combined Truqap with paclitaxel, found no significant OS benefit to the Truqap combo in the overall study population or in patient subgroups defined by mutations in the AKT1, PTEN or PIK3CA genes.
The CAPItello-281 results also position AstraZeneca as a formidable player in the prostate cancer arena, alongside its fellow pharma powerhouses, which have delivered a string of late-stage victories in the indication in recent months.
Pfizer, for instance, announced last month that its PARP inhibitor Talzenna, combined with its androgen receptor pathway inhibitor Xtandi, significantly boosted survival in patients with metastatic castration-resistant prostate cancer (mCRPC) versus Xtandi alone. These findings could help the pharma expand the coverage of Talzenna plus Xtandi to include all mCRPC patients regardless of biomarker status.
In January 2024, Roche and Exelixis scored a late-stage victory for the combo regimen of Tecentriq and Cabometyx, which improved PFS in mCRPC patients as compared with a second novel hormonal therapy. Novartis in October 2023 also notched a Phase III prostate cancer win for Pluvicto, positioning the radiopharmaceutical asset as an earlier-stage treatment option in this indication.
